2/2/2014 1

Jobs That Crossed My Desk Through Feb. 2, 2014 Complimentary Service of Audreysnetwork.com

Feb. 2, 2014

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. Cath Lab Capital Equipment Sales Northern CA/WA/NV, 100k base 200/250 at plan. Experience selling 50k+ equipment into Cath Labs required. Joy@legacymedsearch.com ******************************************************************************** Newest Jobs at JGB BioPharma Consulting- Week of 2/3/14 To apply for a position send your resume to Jobs@JGBBioPharma.com Head of Project Management – Full Time Position (San Francisco Bay Area) R121MT DESCRIPTION: The position requires a seasoned hands-on professional to ensure that timelines are met, issues anticipated, resources are allocated and product development planning is maximized through an interdisciplinary team. In the near term, the position will act as the Project Director and Project Management lead for key programs, and then eventually will create a project management organization to oversee multiple programs. Responsible for product portfolio and project planning process for the organization. This includes

implementing portfolio management strategies and technology assessment processes and overseeing project planning methods for preclinical through clinical programs to launch or partnering milestones. The project management and planning includes return on capital analysis, risk profile and resource requirements, and is integral for the corporation’s annual operating and budget plan. The position is key to determine and oversee timeline management and risk analysis in order to meet corporate objectives. This position will lead the effort for continuous improvement of project operations, direct the operational aspects of the organization’s pharmaceutical partnerships, and direct programs and maximize resources through project management best practices.

Will report to CEO and will work closely with the executive team, functional leaders and program team representatives to achieve results in a matrix environment, and will be responsible for managing and influencing internally and externally to achieve project objectives on time and on budget.

Implement project management infrastructure, in addition to initially managing the day-to-day operations of the project teams and driving the deliverables.

Develop timelines, performance objectives, deliverables and meeting protocols for all project teams.

Participate in senior management and executive committee meetings to align corporate objectives with project team activities and deliverables.

Identify and solve resource allocation, product development risk areas and financial budget responsibilities and variances.

2/2/2014 2

Anticipate potential issues and roadblocks to achievement of objectives; strategize and implement solutions.

Create dashboard and project team timeline snapshots for senior management updates. Be a spokesperson for product development, portfolio planning and project management teams. Be the senior operational contact for all partnered programs. Responsible for making decisions regarding the appropriate risk when there is substantial program

impact. Recommends, implements, and manages the appropriate program structure and standard

performance metrics. Contributes to the creation and maintenance of historical databases for the purpose of tracking,

trending, learning, and improving decisions regarding program performance and continuance. Maximizes business results through continuous improvement in organization's ability to execute

programs from initiation to completion and production scale. Leads development team in defining program strategies and developing goals for the budget

process. EXPERIENCE AND QUALIFICATIONS: Experience as a VP or Head of project management, or a candidate who has clearly demonstrated

those skills. Extensive product development expertise and understanding of all stages of drug development;

biologics drug development experience preferred. Functional expertise outside of Project Management (i.e. Clinical, Finance, R&D, Operations). Outstanding analytical abilities to review financial and project data and resolve project issues. Excellent written and oral communication. Strong interpersonal skills, conflict management skills, and influencing skills. Facilitation, presentation, problem-solving, and conflict resolution skills. The ability to interact with, and influence senior internal and external stakeholders. Senior leadership experience with strategic planning, relationship management, and change

management skills to collaborate and influence at all levels within the organization. BS/MS or PhD in relevant scientific field, or MBA. 15+ years experience in pharmaceutical/biotech industry, with proven track record of success.

____________________________________________________________________________________________________________________ Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D DESCRIPTION: Supports the planning and implementation of clinical development plans required for evaluating the

efficacy and safety of investigational drugs and biologics. This position will support the medical monitoring activities and assist Sr. Director, MD, Clinical

Development, in the management and oversight of Phase II trials, leading to Phase III trials. The therapeutic areas of interest include respiratory and oncology. This position reports to Sr. Director, MD, Clinical Development. Supports medical monitoring efforts in Phase II trials Supports strategic clinical trial input to the clinical operations team Supports investigator selection and evaluations Supports evaluation of safety data from clinical trials and reports safety findings to regulatory

authorities and licensing partners Supports writing efforts on clinical study reports Reports status of clinical programs to project teams and management Identifies and maintains liaison with leading investigators in the areas of medicine where products

are being developed Reports clinical study findings at professional meetings Assists project teams to identify clinical indications appropriate for investigational drugs EXPERIENCE AND QUALIFICATIONS: At least two years of experience in drug development in the biotechnology or pharmaceutical

industry; respiratory experience desired, but not required. Knowledge of clinical trial design, data interpretation and analysis

2/2/2014 3

Ability to analyze, interpret, and report clinical trial findings Effective oral and written communication skills Strong interpersonal skills and ability to work effectively with project teams Medical Doctor degree, board certified ____________________________________________________________________________________________________________________ Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX DESCRIPTION: Identify and assist in the management of safety concerns with drug product(s). Ensure that any safety signals are appropriately evaluated, communicated and managed with

guidance from supervisor. Responsible for writing documents required for assessment & communication of product safety

information for core safety documents. Perform aggregate safety data tabulation and listing compilation. Able to provide some clinical

judgment on safety data review Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups

in identification, analysis, and reporting of possible trends or concerns Contribute to development & maintenance of product safety profile Track events of special interest and assist in development & maintenance of standardized queries

for events of special interest Support the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc

inquiries regarding safety issues Draft regulatory inquiry responses Provide input and review to key regulatory or clinical documents (i.e. clinical study reports,

investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director

Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis.

Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners

EXPERIENCE AND QUALIFICATIONS: Previous experience in scientific /medical writing required Ability to read and collate scientific and medical literature Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both

safety reporting and processing for clinical trial environments Working knowledge of MedDRA dictionary Familiarity with common safety databases (e.g. Argus, Aris) is preferred Proficient with Windows: MS Word, Excel, PowerPoint and ability to learn new programs as needed Must have excellent writing and communication skills Collaborate effectively with the study team, cross-functional team members, and external partners. MSc, Pharm.D., Ph.D. preferred Minimum of 3 years experience with pharmacovigilance or clinical safety ____________________________________________________________________________________________________________________ Senior Clinical Drug Safety Specialist – Full Time Position (San Francisco Bay Area) TD114J DESCRIPTION: Responsible for narrative writing and case processing of serious adverse event (SAE) data within

department timelines assuring compliance with SOP’s and FDA regulations for the reporting of adverse events to regulatory agencies.

Acts as mentor for junior staff members and performs Quality Control on other team members work.

Ability to work independently and prioritize workload. Support all Drug Safety activities for sponsored trials and programs, to include: Use medical background and experience to integrate case-related information including medical

conditions, lab results and procedures to write comprehensive SAE case narratives Generate clinically relevant SAE queries to obtain missing information Act as Team Lead for products/studies as applicable Represent Clinical Drug Safety as a member of study management teams

2/2/2014 4

Assist in the oversight of CRO and business partners to ensure adherence to safety management plans and data exchange agreements

Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, European clinical expert reports)

Assist in the creation/revision of department procedures and policies Assists with Safety Science pharmacovigilance projects as necessary Performs other duties as requested. EXPERIENCE AND QUALIFICATIONS: Strong organizational, management, teamwork, and interpersonal skills and professionalism

required. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically

sound and understandable way Outstanding communication skills (verbal and written). Focus on detail with enthusiasm to constantly seek ways to improve processes and practices. Ability to manage multiple projects in a fast-paced environment. Collaborate effectively with the study team, cross-functional team members, and external partners. Previous Drug Safety/Pharmacovigilance experience of at least 3-4 years in a global environment. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both

Safety reporting and processing for clinical trial environments. Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding. Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as

needed. Familiarity with common Safety databases (e.g., Arisg, AERS, Argus, etc.) necessary. At a minimum, Bachelor’s level degree in life sciences, pharmacy, or nursing. RN, PharmD, or MD

strongly preferred. ____________________________________________________________________________________________________________________ Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ DESCRIPTION: Accountable for the day-to-day management and performance of case management team

activities. Responsible for managing all aspects of safety operations by ensuring the accurate and timely

collection, recording, evaluation and reporting of adverse events involving clinical trial and post-marketing studies.

implements department policies and operating procedures. Develops systems, tools and processes for drug safety operations. Reviews and approves adverse event analyses and reports prepared by staff for submission to regulatory agencies. Collaborates with clinical teams, regulatory teams, clinical research organizations and corporate partners in the development of safety reporting procedures and post marketing activities. Sets project goals, timelines and resource requirements. Maintain efficiency of the case management activities.

Ensure that all Safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements (of all relevant countries), alliance agreements, and OPs and procedures.

Perform, or provide oversight for, all case processing activities including data entry, narrative writing, quality control, and coding of all cases to ensure accuracy, integrity and completeness of information entered in the Safety database.

Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes (as needed).

Manage vendor safety reporting activities including site queries, extraction of eCRF information, and quality assurance.

Lead, or participate in, safety data analysis and/or procedure development projects to support the Clinical Drug Safety Science group. Participate in the planning and preparation of the adverse event and/or risk sections of protocols, IBs, and ICFs for studies and review of CRFs (as necessary).

Support the Clinical Operation teams with respect to safety related issues as required. Participate in Clinical meetings representing safety. Oversee reconciliation of Safety database with clinical database for a given study.

2/2/2014 5

Provide expert guidance on regulations and their impact on safety management processes and procedures.

Participate in the development and management of Data Monitoring Committees, including development of charters and ensure that activities/listings for meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/IECs and/or regulatory authorities.

Develop, manage, and implement departmental safety policies and SOPs. Manage drug safety staff members, as applicable. Performs other duties as requested. EXPERIENCE AND QUALIFICATIONS: Previous Safety/Pharmacovigilance experience of at least 5 years in a global environment. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both

Safety reporting and processing for clinical trial environments. Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding. Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as

needed. Familiarity with common safety databases (e.g., Arisg, AERS, Argus, etc.) a must. Strong organizational, management, teamwork, and interpersonal skills and professionalism

required. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically

sound and understandable way Outstanding communication skills (verbal and written). Focus on detail with enthusiasm to constantly seek ways to improve processes and practices. Ability to manage multiple projects in a fast-paced environment. Collaborate effectively with the study team, cross-functional team members, and external partners. Education Requirements (degree, certifications, etc.): At a minimum, Bachelor’s level degree in life sciences, pharmacy, nursing or RN. Master’s Degree

or PharmD preferred. ____________________________________________________________________________________________________________________ Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A DESCRIPTION: Responsible for the medical oversight of global pharmacovigilance activities of clinical trials and

product development. Post-marketing safety experience is highly desirable. Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug

Safety Department. Perform or provide oversight for the medical review of serious adverse event reports to ensure

accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.

Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.

Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management

Support both Clinical Science and Clinical Operations teams with respect to safety related issues as required

Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.

Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.

Oversee the activities of both internal safety meetings and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings).

Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.

Support development and maintenance of product benefit-risk profile Manage Drug Safety Science staff members, as applicable. EXPERIENCE AND QUALIFICATIONS:

2/2/2014 6

General knowledge of pharmaceutical development and a minimum of 5 - 7 years of experience in Safety/Pharmacovigilance in a global environment.

Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.

Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding. Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as

needed. Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) Argus experience

preferred. Strong organizational, management, teamwork, and interpersonal skills and professionalism

required. Ability to evaluate and interpret adverse event/serious adverse event reports and other documents

to be used in Safety/Pharmacovigilance submissions. Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically

sound and understandable way. Outstanding communication skills (verbal and written). Ability to manage multiple projects in a fast-paced environment. Collaborate effectively with the study team, cross-functional team members, and external partners. M.D. required ____________________________________________________________________________________________________________________ Medical Director – Full Time Position (San Francisco Bay Area) B114TN DESCRIPTION: Develops the strategies, designs, implements, monitors and evaluates clinical trials and other associated clinical development programs for assigned molecules or drugs. Medical Director will be assigned responsibilities for Ph II and Ph III clinical trials, programs and/or other projects. Work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities. Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy.

Helps Research and to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects

May also consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio

Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs

Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)

Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities. Includes playing a key role in the organization and delivery of successful expert advisory boards

Participates in FDA or other health authority interactions with little or no supervision from his/her manager

Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings. Supports Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug’s Package Insert. Acts as the clinical lead on Filing Teams. Monitors IND filings for all assigned molecules and programs

Provides clinical oversight for a variety of projects: Works with a host of internal and external partners and stakeholders in the design and

implementation of clinical trials for assigned molecules and drugs Designs and develops trial protocols; including effectively incorporating cross-functional strategies

and input into programs Develops the product safety profile Gains alignment with various internal partners and stakeholders on goals and resource needs.

Includes working with core team project teams to establish appropriate budgets and other resource plans

2/2/2014 7

Develops key clinical sections of Investigator brochures Plays a key role in the identification of appropriate external investigators Produces clinical components of presentations at clinical trial investigator meetings; delivering

high-quality presentations at such meetings Converts clinical development plans into project implementation plans and leads clinical trial

implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally. Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such

Plays an important role in the development of disease and/or treatment registries. Includes developing strategies or plans to enable appropriate registry recruitment

Keeps all partners abreast of developments throughout all applicable intervals Contributes to safety and/or other relevant sections of IND annual reports, as these sections and

reports relate to assigned molecules and/or drugs May interact with Board of Directors and Investor Relations Works closely with Clinical Operations to close-out clinical trials and complete internal reporting of

trial status and results; including associated publications EXPERIENCE AND QUALIFICATIONS: Boarded in hematology or oncology Biotech/pharmaceutical industry experience preferred OR be a recognized expert in the field Strong background/experience with clinical trials (as typically measured by 2 or more years’

experience) Strong, relevant therapeutic experience (as typically measured by 3 or more years’ relevant clinical

experience) In-depth understanding and firsthand knowledge of Phase I-III drug development. Broad experience in the principles and techniques of data analysis, interpretation and clinical

relevance (e.g., ISS, ISE, competitor data, etc.) Demonstrate ever-increasing competence and abilities in leading disease strategy planning and

reviews. Expected to provide important, strategic inputs in Clinical Development decision-making Create targeted and executable clinical development plans for multiple molecules and or drugs Deliver multiple projects and programs on-time, on-target and within-budget Develop and cultivate important relationships with internal and external partners and stakeholders.

Includes developing and cultivating important relationships with thought leaders and KOLs (key opinion leaders)

Competently and collaboratively interact with a host of internal and external partners and stakeholders

Effectively represent Clinical Science on multi-disciplinary teams. Stay informed and abreast of the external landscape as it relates to assigned molecules, drugs

and/or programs and the associated therapeutic area(s) Comprehensive understanding of product and safety profiles Well-versed in medical aspects of FDA regulations

Apply Here: http://www.Click2Apply.net/7cj233w Bioinformatics Software Engineer The J. David Gladstone Institutes Location: San Francisco, CA Posted Date: 1/14/2014 Position Type: Full time

2/2/2014 8

Job Code: C14-01BSP Salary: Required Education: Bachelors Degree Areas of Expertise Desired: Bioinformatics, The Gladstone Institutes is an independent, not-for-profit research institution affiliated with the University of California San Francisco (UCSF), contributing to the health and well-being of all people through medical research, education, and outreach in the areas of heart disease, HIV/AIDS, and neurological disease. Gladstone is composed of three separate institutes and approximately 400 employees. Our employees receive exceptional benefits. We are located in an award-winning building adjacent to UCSF's Mission Bay Campus. Gladstone has consistently ranked as one of the top places to work in academia in the United States. Job Description: We are recruiting a Bioinformatics Software Engineer to support the bioinformatics needs at Gladstone. Main duties will involve developing and maintaining scientific databases and performing data analysis of large-scale genomic data. Primary projects will include developing tools for analysis of metagenomics data (from human body sites and environmental samples) and designing pipelines for next-generation human genomics and epigenomics research. The candidate will interact with labs spanning all Gladstone Institutes. Requirements The candidate should have a BS in Bioinformatics, Computer Science or similar field and at least 2 years experience with MySQL or other relational database software and scripting languages (e.g., Perl, Python, shell scripting). MS or PhD is desirable. Experience with analysis of large biological datasets, including developing pipelines for analysis using R and scripting languages in a Linux environment is required. Knowledge of programming languages (e.g., Java, C/C++) and best practices is also important. Additional useful experience includes the ability to work in a distributed computing environment using a queuing system such as SGE or PBS and a demonstrated ability to create data visualization tools. We need a good communicator who can work across disciplines, and a self-starter who can work effectively on projects with long development times. Please address how your experience fulfills these requirements in a cover letter and/or resume. Candidates with relevant expertise who wish to join Gladstone’s mission of preventing, treating and curing some of the world’s most relentless diseases should send their curriculum vitae and contact information for three references. ************************************************************************************************* Apply at http://goo.gl/6kep8F

Drug Product Technical Operation Manager / Specialist-Pharmacyclics, Inc.- Sunnyvale Job Code: 11-HC-1 Salary: Required Education: Bachelors Degree Areas of Expertise Desired: Manufacturing/Production Primarily responsible for the production of drug products intended commercial markets and clinical

2/2/2014 9

studies. Oversight of drug product manufacturing activities at contract manufacturing organizations. Key Accountabilities/Core Job Responsibilities: • Provide technical review of batch records and associated documents for commercial drug products manufactured at the CMO. Function as technical expert to formulate solutions to complex manufacturing issues. Collaborate with internal quality organizations to enable timely lot release and issue resolution. • Interact with the supply chain group at Pharmacyclics to monitor and direct the drug product production schedule in accordance with the supply forecast. • Create and maintain manufacturing database and lead continued process verification efforts. Compile and interpret intra- and inter- batch data to assess variability and formulate strategies to minimize and improve process control. • As necessary, function as Person-In-Plant to oversee GMP manufacturing operation performed at CMO site. Formulate solutions to complex manufacturing issues. • Assist in formulation and process development studies as needed. Requirements • Solid background in solid dosage form manufacturing processes. Experience in managing CMO’s required. • Thorough understanding of regulatory guidance as applied to solid dosage forms and cGMP. • Excellent organizational and time management skills. Team Player. • Advanced communication and technical writing skills. • Strong strategic planning ability as well as detail-oriented thinking required. Experience: • 5+ years of relevant experience in the pharmaceutical industry. Level and salary commensurate with experience. • Working knowledge in GMP enviroment and familiar with investigation,deviation and CAPA process. Education Requirements (degree, certifications, etc.): • Include must have and preferred BS in a scientific discipline.

Drug Product Technical Operation Manager / Specialistqmedcareercentral.devicespace.com Pharmacyclics, Inc. has an opening for a Drug Product Technical Operation Manager / Specialist in Sunnyvale,...

************************************************************************************************** Senior IT Systems Engineer- Five Prime Therapeutics-South San Francisco Code:NA1102014 Five Prime Therapeutics is a newly public, clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases. We are currently leveraging our platform to identify novel targets in the area of cancer immunotherapy. We have an emerging portfolio of innovative products for inflammation and cancer including: FP-1039 – an FGF ligand trap in Phase 1b for solid tumors FPA008 – a monoclonal antibody targeting CSF1R in Phase 1 for RA FPA144 – a monoclonal antibody targeting FGFR2b in IND-enabling studies for selected gastric cancers On the strength of our unique discovery platform and capabilities, we have entered into discovery collaborations with several leading biopharmaceutical companies. The IT Systems Engineer will be responsible for designing, building and maintaining robust information technology infrastructure and operations at Five Prime and will report to the Director of Systems Engineering & IT. The position offers excellent growth opportunities in both technical and

2/2/2014 10

management functions along with experience in enabling state of the art, data intensive scientific operations. Responsibilities: • Improve, optimize and maintain IT infrastructure and services to ensure high availability and reliability. • Windows Server administration – installation, configuration, active directory, group policy, remote access (VPN, remote desktop), file and print servers. • Work with external service providers to provide support for cloud based software services such as SharePoint and Office365. • Storage, backup and disaster recovery administration – Manage a heterogeneous enterprise storage environment including storage platforms (NetApp, Nexenta, etc), file servers (Windows and UNIX), cloud storage, and work with external service providers to administer back up and disaster recovery. • Network administration – Configure, deploy and maintain network hardware and software. Maintain network integrity and security. • Work closely with members of the data integration group and provide support for infrastructure hosting databases (SQL Server, Oracle, MySQL), image servers and webservers (IIS, Jetty) • Develop and deploy robust IT management practices and processes. Develop and maintain active documentation of IT infrastructure and processes. • Assist with IT planning and strategy. • Communicate highly technical information to both technical and nontechnical personnel. Required Education and Experience: • A bachelor’s degree with 5+ years of experience as an enterprise IT Systems Engineer. • Ability to diagnose and troubleshoot problems in a heterogeneous desktop and server environment. • Experience with Windows server and domain administration. • Experience with scripting (e.g. PowerShell) and process automation. • Experience with server virtualization and VMware platform administration. • Experience with administering enterprise storage platforms such as NetApp, Nexenta, etc and cloud storage. Experience with administering back up and disaster recovery. • Experience with Network design, implementation and network management. Networking skills including configuration of switches, routers and other networking equipment and network services such as DNS, DHCP, Firewalls and VPN. • Intermediate level experience with Linux and Mac OS. • Excellent interpersonal and leadership skills and experience in working with external service providers and contractors. • Excellent verbal and written communication skills. • Ability to prioritize and manage multiple projects simultaneously and effectively. • Intrinsically motivated, with a passion for technology, innovation, and enabling outstanding Science. ****************************************************************************************************************** Apply on company website

Senior Manager, R&D – Product Development Allergan - USA-CA-Santa Barbara Posted 13 days ago Job description Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have approximately 10,500 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

2/2/2014 11

The Senior Manager, R&D leads the design and development of medical devices, testing equipment and novel materials for the Product Development department. Mentors and coaches an engineering group that designs, tests, integrates, documents and validates new concepts, new materials, and new designs. Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines.

• Interacts frequently with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements and/or contractual clarifications. Leads briefings and technical meetings for internal and external representatives.

• Responsible for Aesthetics Product Development design control projects/systems. Leads Product Development sub teams in the completion of PD deliverables for organizational project teams.

• Facilitates problem solving techniques to overcome complex technical problems and provide solutions which are highly innovative.

• Provides Leadership to Product Development engineers and contract manufacturers to develop and implement prototypes, prototype tooling, testing equipment, and testing/manufacturing procedures.

• Leads and manages the support for Operations Engineering in failure investigation and product enhancement on existing products.

Qualifications Education and Experience: B.S. Engineering or other related discipline with 11 years of experience OR M.S. with 9 years of experience OR PhD with 6 years of experience. Prior managerial experience highly desired. Medical device experience highly preferred. Essential Skills and Abilities:

• Extensive experience in engineering program and project management. • Comprehensive design experience in product development. • Experienced user of PC based design tools (design simulation, CAD - e.g. SolidWorks,

AutoCAD, Mechanical Desktop). • Knowledge of cost effective design techniques. • Experienced in leading large scale projects and programs and direct supervision of Project

Managers and advanced level engineers. • Successful experience with development of medical devices from early stage on to design

control and market release. • A team attitude with positive outlook is a must. • Ability to lead and directly manage a group of high level technical (Sr. Engineers, Sr. Project

Managers) personnel. • Leadership/Ownership skills to take a project from concept to market release • Support of Manufacturing to resolve production problems. • Excellent communication skills, both written and oral. Ability to prepare technical reports

and presentations to senior level management. • Creation of schedules and tracking of tasks to these schedules. • Creation/management of program budgets with multiple projects. Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have 11,000+ highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics and urologics, Allergan is proud to celebrate

2/2/2014 12

more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

___________________________________________________________________________________________

Apply on company website Sr. Business Relationship Manager, Research and Laboratory Systems - Santa Barbara, CA Allergan - USA-CA-Santa Barbara Posted 6 days ago Job description Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers. Establishes and maintains relationships with Allergan R&D Device users to deliver high-quality, innovative and compliant IT solutions. Works with Allergan R&D Device Leadership Teams to develop strategic and tactical IS plans. Negotiates prioritization of efforts by facilitating communication between with R&D Device Leadership and various R&D Informatics Services (RDIS) teams. Possesses strong expertise in R&D Device processes and operations as well as an understanding of Allergan’s technology platforms, systems and capabilities. Manages Research and Development (R&D) applications and performs light system administration in support of R&D Device Engineers (mechanical and electrical), Biologists, and Chemists. Typical systems include: EDA, CAD, and CAM systems; Product Data Management systems, Design Simulators; Physical, Chemical, and Biological characterization equipment and software; Electronic Laboratory Notebooks, and 2D/3D image acquisition, storage, and archival. Leads cross functional project teams to gather requirements, design, and implement systems. Assists in business process redesign efforts to leverage the capabilities of new technology solutions. Provides expertise in vendor provided and in-house developed software tools for projects of small to medium size or complexity. Manages vendor work quality, productivity and deliverables. Participates in managing vendor relationship and contracting activities. Qualifications Education and Experience

• 8 or more years experience with a Bachelor's Degree in a relevant field of work or equivalent experience; 6 or more years experience with a Master's Degree in a relevant field of work or equivalent experience.

• 5 or more years of relevant work experience in Information Technology (IS Project Management, Consulting, Business Analysis, etc.).

• 3 or more years deploying, supporting and/or developing laboratory systems in the medical device or pharmaceutical industry.

• 3 or more years supporting computer system validation projects for laboratory systems. • 2 or more years of project management experience in a multi-project environment using formal

project management methodologies, techniques, and tools. • PMP Certification preferred. Essential Skills and Abilities

• Relationship Building, Communication and Leadership Skills. • Proven ability to develop and cultivate relationships with business customers.

2/2/2014 13

• Ability to communicate and work effectively with others, especially under pressure of meeting project deadlines.

• Highly developed interpersonal, oral and written communication, negotiation, facilitation and leadership skills.

• Ability to manage others with varying degrees of technical and scientific knowledge. • Strong background in R&D systems, applications development, and processes within the medical

device business. • Ability to facilitate meetings (e.g., status meetings, functional requirements gathering, process flow

development workshops, end user training, etc.). • Well organized with the ability to manage and prioritize multiple simultaneous complex projects

(often with changing timelines and dependencies) in a matrix team environment. • Proven analytical skills with the ability to evaluate needs and develop and implement effective

solutions. • Ability to identify risks and escalate when necessary. • Willingness and ability to travel up to 25%. Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, we have 11,000+ highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics and urologics, Allergan is proud to celebrate more than 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

********************************************************************************************************************************* Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://jgbbiopharma.com/jobs-category/biostatistics-data-management-related-jobs

Director, Statistical Programming – Full Time Position (San Francisco Bay Area) PPBI Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Lead the statistical programming activities for multiple compounds and will lead the programming submission related activities. • Establish standards for programming and efficiency within the group. • Manages a team of statistical programmers. • Identifies new tools to increase group productivity. • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures. • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. • Excellent verbal and written communication skills and interpersonal skills are required.Has understanding of the business beyond the functional area. • Capable of recommending new operating procedures as appropriate and determining if the analysis infrastructure needs changes to improve efficiency and minimize errors. • Must be able to lead strategic initiatives for the statistical programming group. • Represents the statistical programming group at project team meetings. • Has the proven ability to directly supervise personnel. EXPERIENCE AND QUALIFICATIONS:

2/2/2014 14

• Submission, ISS, and ISE expertise • Leadership skills • Experience in multiple therapeutic areas is desired • Experience in clinical development statistical programming methods and processes in industry setting required • Experience in direct management of statistical programmers • Experience and in-depth knowledge in CDISC including SDTM, ADaM, Metadata, and controlled terminologies • Enable to establish process and develop utilities efficiently for different versions of Implementation Guides and Standards. Enable to assess the impact of procedural or system changes , and develop/implement strategies to maintain consistency of programming • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application • Good presentation, oral and written communication skills, including a customer base focus, a commitment to quality management, and problem solving experience. • 11 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 7 years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or 5 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

***************************************************************************

Jobs That Crossed My Desk Through Jan. 26, 2014 ************************************************************************ Apply on company website Centers for Therapeutic Innovation - Research Project Leader Pfizer Inc - La Jolla, California Posted 2 days ago Job description Org Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place. Role Description Department Marketing Statement Centers for Therapeutic Innovation (CTI) is an entrepreneurial network of partnerships with leading academic medical centers (AMC) that aligns leading scientific and clinical experts from the AMCs with Pfizer's world-class scientists, drug development capabilities and breadth of resources to speed the translation of breakthrough science into innovative medicines for patients. CTI's scientists work alongside with academic post-docs assigned to sponsored programs towards the common goal of translating science into novel Proof-of-Mechanism (PoM) studies across multiple therapeutic areas and indications to ultimately increase the probability of reaching Proof-of-Concept (PoC) and bringing novel and differentiated medicines to patients. To date, CTI has established collaborations with 23 AMCs in New York, Boston, San Francisco and San Diego. Job Focus CTI seeks an individual with a strong background in small molecule drug development. The successful candidate will lead cross-functional project teams from the discovery/screening stage through clinical candidate. Projects are formed as collaborations between Academic Investigators and Pfizer Scientists representing several functional areas. Projects can be focused in any of several therapeutic areas. Skilled leadership and excellent interpersonal and communication skills are musts. Responsibilities *Review Academic proposals from the CTI network. Co-author drug development plans and statements of work for chosen projects.

2/2/2014 15

*Lead small molecule drug development project teams. Will set strategy and drive decisions for cross-functional, matrixed teams consisting of Academic collaborators, chemists, cell biologists, pharmacologists, toxicologists, pharmacokineticists, and others as needed. *Work closely with a project manager to plan and oversee the execution of project activities for multiple project teams. *Interact and coordinate with several Pfizer departments and therapeutic research units in accomplishment of team goals and timelines. *Analyze, interpret, and present scientific and logistical data at internal and external meetings. Prepare publications. Qualifications *PhD in Chemistry, Life Sciences, or a related field *8 - 12 years of industry experience *Strong project leadership skills *Experience leading preclinical small molecule drug development teams *Previous successful delivery of molecules when leading teams *Capable of leading multiple projects in parallel *In depth knowledge of chemistry and biology related to small molecule drug discovery *Excellent interpersonal and communication skills *High level of self-motivation and ability to thrive in a goal- and team-oriented setting Equal Employment Opportunity Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. ********************************************************************************************************************** Apply on company website Research Product Manager 23andMe - Mountain View, CA Posted 1 day ago Job description 23andMe empowers individuals with access to and understanding of their own genetic information while harnessing the power of this data to drive breakthrough research. We are seeking an outstanding Research Product Manager to lead all aspects of the consumer facing and partner facing 23andMe research offering. This is an opportunity to craft an experience that turns individuals into research accelerators and helps researchers uncover genetic insights with unprecedented power, speed, and flexibility. This research has the potential to truly impact peoples’ lives. The right candidate will have a relentless user focus, passion for using data to improve peoples’ lives, unique ability to make complex concepts simple, and deep curiosity into the “whys” behind each element of the experience. You must have an ability to see the big picture while also being detail and execution

2/2/2014 16

oriented, have a strong POV while being highly collaborative and communicative across teams, and be thoughtful about all touchpoints in the user lifecycle. Valued Qualifications:

• Passion for improving peoples’ lives through innovative health products • Product management experience with data tools, consumer, and/or health • MBA or similar advanced degree • Knowledgeable in technology • Genetics, biology, psychology, sociology, or healthcare domain experience/expertise • Strong product and design sense • Strong oral and written communication skills • Highly collaborative leader • Detail and execution oriented • Experience with statistics and data analysis • Experience with quantitative and qualitative user research 23andMe, Inc. is a privately-held company dedicated to helping individuals understand their own genetic information using recent advances in DNA analysis technologies and web-based interactive tools. 23andMe enables individuals to gain deeper insights into personal ancestry, genealogy and inherited traits. **************************************************************************************************************** Newest Jobs at JGB BioPharma Consulting- Week of 1/27/14 Engineer II Electrical – Full Time Position (San Francisco Bay Area) RB73Y DESCRIPTION: Interfacing with product development, production, vendors and other groups to improve and

update designs for manufacturability, testability, reliability, and cost savings. Contribute in areas of electrical design of PCAs, power distribution, cables, harnesses and other

electronic subassemblies. Responsible for providing support to products already released into production by solving

manufacturing issues, as well as, problems reported from the field. Develop and maintain all manufacturing related documentation for instruments and subassemblies

(i.e. BOMs, Procedures, Datasheets, Manufacturing Deviations, Drawings, etc.). Develop test specifications and work w/suppliers to develop and implement PCA test fixtures. Develop and implement PCA test procedures and datasheets. Determine fixture requirements and write test plans. Design, build, test and troubleshoot PCAs and PCA test fixtures Work with suppliers to improve

manufacturability, resolve quality issues and realize cost reductions. Design, build and document cable and harness assemblies. Select, procure and manage components for use in breadboard PCAs. Build breadboard and pilot instruments Work with the design team to ensure subassemblies and instruments are manufactureable and

testable. Transfer product designs to manufacturing sites EXPERIENCE AND QUALIFICATIONS: Proven experience with designing and implementing subassembly and PCA functional test fixtures Working knowledge of analog and digital circuit design, switching power supplies, communication,

programmable logic and control systems Able to use AutoCAD, OrCAD Capture, and PADS Layout Able to troubleshoot and repair PCAs to the component level Able to fabricate and troubleshoot electronic circuit and system prototypes Clear understanding of MRP Strong verbal and written communication skills Team player who can work well under aggressive deadlines Must be well organized and able to document project activities Must be self-motivated and requiring minimal supervision Must have a clear understanding of Good Manufacturing Activities (GMP, cGMP) Experience with regulatory/safety compliance testing

2/2/2014 17

Experience leading/managing projects. Able to develop practical plans/schedules from general strategies.

Able to conduct vendor, ISO or other internal/external audits. The candidate must have a minimum of 2 yrs directly related manufacturing experience with

electromechanical instrumentation/devices and a minimum of BS in Electrical Engineering, Physics or equivalent.

Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) R82BW DESCRIPTION: Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality

metrics are met for a Phase 1 oncology trial Serves as primary contact for functional area representatives in managing the financial aspect of

clinical trials to ensure accuracy and timeliness of service provider and site payments. Oversight for forecasting of clinical supplies Manage study milestones to ensure accurate tracking and reporting of study metrics. Manage trial-specific collaborations with other research entities. Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including

independent negotiation of scope of work, budgets, performance management, and issue resolution. Create and manage clinical trial budgets and staffing/resourcing plans. Provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate. Manage adherence to ICH/GCP/local regulations. Participate in clinical operations initiatives and programs as assigned and other duties as assigned. Establish and maintain a work environment that fosters learning, respect, open communication,

collaboration, integration, and teamwork. Other duties as assigned. EXPERIENCE AND QUALIFICATIONS: Broad and current knowledge of regulations, clinical development process and therapeutic area to

study plans. Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics

are met. Excellent communication skills to effectively disseminate information within clinical as well as other

functional areas as appropriate. Experience developing trial plans including developing creative strategies for site monitoring, risk

mitigation, trial budgets, site selection, and clinical supplies management. Extensive clinical research knowledge and cross-functional understanding of clinical trial

methodology. Excellent organizational and negotiation skills. Proven ability in creative problem-solving and possess sound judgment. Team oriented and collaborates effectively with the clinical operations study team, cross-functional

team members, and external partners. Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel,

PowerPoint, and Outlook. Working knowledge of MSProject for development and update of clinical study timelines. Willing to travel – anticipate 25%. Bachelor’s Degree with 8+ years of clinical research experience. Clinical Consultant (24 to 40 hrs/ week) Long Term Contract – Contract to FTE (San Francisco Bay Area) Z124RJ DESCRIPTION: Work directly with the Medical Director at a well-funded pre-IND start-up to initiate the first clinical

study (Phase I / 2A) Select CRO and study s Support the writing of the investigator brochure and protocol Develop budget and timeline scenarios and a clinical project plan Manage more junior clinical operations consultant(s) EXPERIENCE AND QUALIFICATIONS:

2/2/2014 18

Knowledge of GCP and ICH guidelines required Proficiency in the implementation, monitoring, and management of clinical trials Able to work collegially within a team and carry out duties/responsibilities with general instructions Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project Must be willing to travel occasionally (this is an in-house position so very little travel is required) Previous experience as the lead clinical operations member Clinical study start-up experience is required Demonstrated stellar track record in the oversight of all trial operational aspects including:

budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.

Bachelor’s Degree in a relevant scientific discipline or equivalent At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 7+

years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 3 years prior experience as an Associate Director Clinical Operations or higher level

1+ years managing staff/direct reports. Must be hands on and used to a start-up environment ************************************************************************************************************** Apply Here: http://www.Click2apply.net/xf8xpnc Senior Scientist, RNAi Genentech - San Francisco Bay Area Posted 2 days ago Job description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, CA headquarters: Senior Scientist, RNAi (High Throughput Screening/HTS) Responsibilities: The RNAi High-Throughput Screening group is seeking a highly motivated and innovative Senior Scientist with strong leadership and collaborative skills. This person should have experience in platform automation, siRNA/shRNA knockdown techniques, as well as high throughput cell based assay development. The Senior Scientist will interface with research groups throughout the Genentech Research community and will play a pivotal role in augmenting Genentech’s strong Research division by playing a key role in identifying new therapeutic targets. Requirements: Incumbent will possess a Ph.D. in Biochemistry, Molecular or Cellular Biology, or a closely related field. He/ she should have seven or more years of experience in developing high through-put cell based assays and automation platforms. He/she should have significant experience and knowledge of siRNA/shRNA techniques. He/she should possess strong molecular and cellular biology skills. Incumbent should have experience with development of automation to run and analyze cell based assays. He/she should have the ability to develop and apply new technologies to the field of RNA knock down. Incumbent should have excellent communication and organizational skills and strong knowledge of molecular and cellular biology and automation science along with a publication record that supports this knowledge. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. Apply Below! Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer.

2/2/2014 19

*********************************************************************************************************** Apply on company website Development Scientist Natera Inc - San Francisco Bay Area Posted 1 day ago Job description Development Scientist Natera is looking for a highly motivated, hands-on development scientist to join a world-class team of scientists to enhance delivery of cutting edge lab developed tests. The responsibilities of this position include leading the transfer of tests from research to production and interfacing with the production team to improve and scale existing tests. Desired Skills and Experience Requirements: PhD in genetics, molecular biology, or related field and > 4 years of experience in molecular biology research and development, with emphasis on development Substantial experience in optimizing laboratory methods and workflows as well as developing assays for quality control, verification, and qualification of reagents and equipment Proven success in managing collaborative and individual projects Skilled at writing clear SOPs Familiar with quality management, including design control, and risk analysis and mitigation strategies Knowledge and hands-on experience with various liquid handling robotics platforms as well as adapting and validating assays for robotics Understanding of regulatory requirements under CLIA, NYS, (FDA experience a plus) Knowledge of essential laboratory methods such as qPCR, gel electrophoresis, bioanalyzer, DNA quantitation, PCR, next generation sequencing a plus Company Description: Natera develops genetic tests that help families have healthy children. The company has a CLIA-certified laboratory in California and unique technologies that combine expertise in molecular biology with advanced statistical techniques. These techniques enable Natera to analyze tiny quantities of DNA more accurately than anyone else in the world, primarily serving OBGYN physicians and their patients. The team consists of over 300 statisticians, geneticists, doctors, laboratory technicians and software engineers from top-tier universities. Our technology has been funded by six grants from the National Institute of Health and a group of private investors led by Sequoia Capital and Orbimed investors. Natera is already providing genetic testing services to over 300 IVF centers, OBGYN practices, and partner laboratories in over 30 countries worldwide. Equal Opportunity Natera affords equal employment opportunities to all qualified persons, regardless of race, color, religion, national origin, age, sex, disability, sexual orientation, gender expression, veteran or marital status. To Apply: Please email your resume to resumeL2A@tavistock.com with the subject line: “Research Assistant Position” Research Assistant Position Tavistock Life Sciences - Greater San Diego Area Posted 17 hours ago Job description Tavistock Life Sciences (“TLS”) is the life sciences team of the international private investment organization Tavistock Group. TLS has a long history partnering with scientists to foster innovation and help enable our portfolio companies to maximize opportunities. TLS operates within a culture that fuels creativity, collaboration and problem solving, and prides itself on being a dynamic organization able to respond quickly and reliably to the needs of our companies while maintaining a long-term commitment.

2/2/2014 20

Boxer Capital is the financing vehicle for the TLS team for investments in a portfolio of public company and private equity investments. At Boxer Capital, we leverage our internal expertise in evaluating pre-clinical and clinical data to generate outsized returns for company founders and employees as well as for our investor the Tavistock Group. Boxer Capital has a focus on biotechnology drug development companies across multiple therapeutic indications. Boxer Capital is currently seeking a Research Assistant with a passion for learning and conducting research to join our Level II Analytics team in San Diego, California. Responsibilities of the Research Assistant role include:

• Developing and maintaining accurate and detailed project documentation; including timelines, action items, agendas, and research/project plans;

• Conducting due diligence on a variety of potential investment opportunities into various private and public innovative biotechnology companies;

• Researching molecular targets and pathways within various disease mechanisms with the goal to help the team better understand potential product opportunities to invest in;

• Conduct competitive intelligence and research emerging technologies for existing and potential investment opportunities;

• Ability to synthesize and translate these findings and present them to the team as part of the internal diligence process.

Qualifications include:

• PhD in cancer biology, molecular/cell biology, or immunology; • Experience gained in an academic lab and/or an industry setting; • Up to two years of work experience, including internships; • Self-motivated, proactive approach to work, with the ability to work both independently and in

teams; • Detail-oriented, mature, conscientious, and self-critical; • Creative and innovative approach to problem solving; • Highly proficient in the use of PubMed and able to digest research into presentable forms; • Ability to succeed in a fast-paced, ever changing environment and meet absolute deadlines; • Sharp wit, a desire to gain experience in a research role at a crossover investment fund and a

willingness to work during non-standard business hours; • Excellent written and verbal communication skills; ability to write and communicate complex data

findings in an effective and professional manner with the ability to adapt to varying audiences • Advanced computer literacy in a Microsoft Office environment with strong experience in using

Excel, Word, and PowerPoint to present data. About Tavistock Group: Tavistock Group is an international private investment organization founded by Joe Lewis more than 35 years ago. Our reputation is built on a simple philosophy – we strive for excellence in everything we do. Entrepreneurial and progressive, we value long-term relationships and seek investment opportunities around the globe, which will benefit from our capital, experience, flexibility and broad base of resources. www.tavistock.com ******************************************************************************** Apply on company website Business Analysis & Info Sr Manager Amgen - Thousand Oaks, CA Posted 9 days ago Job description Job Summary The Business Analysis and Information (BAI) Senior Manager will lead all BAI activities in driving the US business for the Enbrel Rheumatology franchise. This highly visible role reports to the Director, US BAI IBU/BHBU Lead.

2/2/2014 21

Job responsibilities include: • Develop productive relationships with the Enbrel Rheumatology brand team/commercial leadership to define BAI objectives, budgets and work plans for performance management in the face of a competitive and dynamic marketplace. • Prioritize research resources to impact critical business issues and decisions. • Partner and influence commercial leadership so they understand and implement key customer and market insights • Provide an objective and rigorous point of view to performance management, while collaborating with other disciplines, e.g., marketing analysis, forecasting, finance, competitive intelligence • Independently plan, design, and conduct simultaneous complex market research projects in support of the annual brand plan/commercial strategic plan • Drives strategic and innovative approaches to key business problems • Manage relationships with external vendors and consultants to enable effective and efficient project execution • Provide analyses and summaries of results, interpreting and communicating results and recommendations to brand/business stakeholders Basic Qualifications � Doctorate degree & 2 years of BAI experience OR � Master’s degree & 6 years of BAI experience OR � Bachelor’s degree & 8 years of BAI experience OR • Associate’s degree & 10 years of BAI experience OR • High school diploma / GED & 12 years of BAI experience Preferred Qualifications • Demonstrated analytical skills—understands the advantages and limits of different analytical approaches and studies and their findings • Demonstrated ability to influence senior executives • Deep understanding of marketing and business analysis concepts • Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences • Demonstrated ability to think strategically to support key business decisions • Ability to work collaboratively in team-based environment • Strong ability to quickly understand the latest developments in the biopharmaceutical industry, and unmet medical needs and opportunities in oncology • Broad, working knowledge of commonly used biopharmaceutical industry databases • Proficient facilitation, negotiation, problem-solving and conflict resolution skills. • Understanding of at least one other functional area in BAI Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. _____________________________________________________________________________

2/2/2014 22

Training & Development Mgr - Oncology Business Unit Amgen - Thousand Oaks, CA Posted 5 days ago Job description The OBU Hew Hire Training Manager is primarily responsible for development, coordination, maintenance, and execution of New Hire training (Phases I – V) for the Oncology Business Unit field sales force. Individual will interact with the OBU Sales and Marketing teams to develop and execute a New Hire training strategy aligned to the current Brand strategic plans and marketplace dynamics. Develop and update training modules, field training curriculum, training exams and role play scenarios, etc.. Work with Compass Training Manager and Sales Operations to train on automated customer management system and sales reporting tools. Individual is responsible for translating national brand plan strategies and tactics into training curriculum/content for new hire training execution. Responsible for creating all training content for brands to newly hired representatives, as well as gain MAC approval and dating of all new hire training materials. Individual will prepare, coordinate, and facilitate new hire training classes with field leadership and guest trainers. Establish training metric/assessment to measure model performance during Phase I – V of the New Hire and report findings to sales leadership. Individual will also assist with POA training for the existing OBU sales force as requested by Strategic Training Managers. Interface with Strategic Training Managers to provide new hire curriculum updates. Individual will also be responsible for other functions and special projects as assigned. Basic Qualifications • Doctorate degree OR • Master’s degree & 3 years of directly related experience OR • Bachelor’s degree & 5 years of directly related experience OR • Associate’s degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience Preferred Qualifications - BA/BS degree - 4+ years of pharma/biotech/healthcare direct selling experience, along with demonstrated ability to transfer skills to a group or an individual - Strong planning and organization skills, talent development, excellent communication skills(written, verbal), problem solving skills, and conflict management skills - Experience in the oncology marketplace highly desirable - Ability to reside/relocate to Thousand Oaks area Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. _________________________________________________________________________________ Sr Associate Project Mgmt Amgen - Thousand Oaks, CA Posted 2 days ago

2/2/2014 23

Job description Under minimal supervision, The Senior Associate Project Management will provide project management support for the Global Scientific Affairs Training and Development (GSATD) team. Responsibilities include managing training program logistics, developing department standards and policies, and working cross-functionally to ensure flawless execution of high quality training programs. Key activities include: •Develop and execute logistics for all live training events •Provide project management support for all Therapeutic Area Senior Managers in GSATD, including items such as tracking and documenting progress of projects, monitoring project expenses, maintaining accurate records and project files, and liaising with the Learning Operations group. •Manage and oversee department budget •Develop and update internal department process documents •Generate quarterly executive dashboards •Coordinate Therapeutic Competency Certifications (TCC) for Scientific Affairs staff •Update GSATD SharePoint portal •Manage timelines and resources and provide editorial support for new hire training materials •Create complex presentation materials and spreadsheets •Anticipate project challenges, troubleshoot, problem solve and recommend solutions Basic Qualifications Master’s degree OR Bachelor’s degree and 2 years of project management / external medical event support experience OR Associate’s degree and 6 years of project management / external medical event support experience OR High school diploma / GED and 8 years of project management /external medical event support experience Preferred Qualifications •Successful track record of project management in the biotechnology and/or pharmaceutical industry •Experience in a Scientific Affairs or Medical Affairs organization •Excellent verbal and written communication skills •Expertise in Microsoft PowerPoint, Excel, and Word •Prior experience supporting a training department •B.S. or higher in related field Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. ********************************************************************************** http://www.linkedin.com/jobs2/view/10694300?trk=eml-anet_dig-b_premjb-ttl-cn Sr. Manager, Market Research/Business Intelligence Penfield Search Partners Ltd - Southern California Posted 2 days ago

2/2/2014 24

Job description Title: Sr. Manager, Market Research/Business Intelligence Location: Southern California – Full Relocation Paid Contac: Monica Prangley, mprangley@penfieldsearch.com This highly visible role reports to the Director, US Business Intelligence on a blockbuster pharmaceutical product. You will be intimately engaged with the brand team and commercial leadership to define research objectives, budgets and work plans for performance management in the face of a competitive and dynamic marketplace. We are looking for a seasoned pharmaceutical market researcher to: • Prioritize research resources to impact critical business issues and decisions. • Partner and influence commercial leadership so they understand and implement key customer and market insights • Provide an objective and rigorous point of view to performance management, while collaborating with other disciplines, e.g., marketing analysis, forecasting, finance, competitive intelligence • Independently plan, design, and conduct simultaneous complex market research projects in support of the annual brand plan/commercial strategic plan • Drive strategic and innovative approaches to key business problems • Manage relationships with external vendors and consultants to enable effective and efficient project execution • Provide analyses and summaries of results, interpreting and communicating results and recommendations to brand/business stakeholders Basic Qualifications: Pharmaceutical, Biotech or Life Sciences experience including: -- Doctorate degree & 2 years of market research/business analytics experience -- Master’s degree & 6 years of market research/business analyticsexperience -- Bachelor’s degree & 8 years ofmarket research/business analytics experience Desired Skills and Experience Preferred Qualifications • Demonstrated analytical skills—understands the advantages and limits of different analytical approaches and studies and their findings • Demonstrated ability to influence senior executives • Deep understanding of marketing and business analysis concepts • Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences • Demonstrated ability to think strategically to support key business decisions Monica Prangley – Penfield Search Partners – Pharmaceutical Market Research – Insights –Business Analytics and Intelligence – Primary Market Research – Innovative Methods – Rheumatology – Oncology – Cardiovascular – Inflammation – Pipeline – Inline Penfield Search Partners Ltd. is an executive recruiting firm dedicated to personalized recruitment services; specializing in two specific areas: ~ Property and Casualty Insurance ~ Pharmaceutical, Biotech and Life Sciences Our Insurance principals, Karen McCorkindale, Andy Davis and Sean de Groot have recruited together for nearly two decades; our Pharmaceutical and Life Sciences practice is headed by principals Kyle Diamond and Kevin McGrath with over 25 years of combined industry expertise. Property and Casualty Insurance - Our relationships include carriers, retail and wholesale brokers, corporate risk buyers and consultants, as well as reinsurance entities. In addition to our broad capabilities, we are recognized as the “go to” firm in the management and professional liability niche markets.

2/2/2014 25

Collectively, our team possesses over 80 years of experience with an outstanding referral to placement ratio. Pharmaceutical, Biotech and Life Sciences – Our relationships include many of the leading pharmaceutical and biotech companies nationwide. Our strength is our niche expertise in sales analytics, marketing sciences, forecasting, market research, marketing, health economics, outcomes research and market access. We are a seasoned team of specialists with knowledge of the influencers, thought leaders and decision makers in the industry. ******************************************************************************* Apply on company website Scientist, Immunology-(Biochemical and Cellular Pharmacology) Genentech - US - California,South San Francisco Posted 2 days ago Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position We have an opening for a talented Scientist to join our Biochemical and Cellular Pharmacology group. The successful candidate will be responsible for supporting Immunological therapeutic antibody projects as part of the biologics drug discovery program in our South San Francisco location. More specifically, the individual will focus on developing, optimizing, and automating both biochemical and cellular functional assays to support the discovery of new protein therapeutics, on projects ranging from early to late stage discovery and IND filing. The scientist will draw on their significant expertise in Immunology to contribute on a multi-disciplinary team by designing functional, binding, bioanalytical pharmacokinetic and pharmacodynamic assays to screen and characterize antibody candidates. The candidate is expected to display leadership in the laboratory by guiding associates at the bench, and leadership in Genentech’s scientific community by guiding drug discovery strategies in multi-disciplinary teams. In addition, the candidate should be proactive and innovative in defining new scientific, therapeutic, and technological strategies to enhance Genentech’s biologics platforms. Who You Are A Ph.D. in Immunology, Biochemistry, Cell Biology, or a related field is required, with at least 2 years of post-doctoral experience and 4+ years of biotechnology or pharmaceutical experience. Experience with a diverse set of functional quantitative assays in the Immunology therapeutic area is essential, and recent experience in bioanalytical protein quantitation using ligand-binding assays or mass spectrometry is highly desirable. The candidate should have a record of scientific accomplishments reflected by publications, presentations, and IND contributions. Proven expertise in modern automation of immunological, cellular and pharmacodynamic assays is essential. Individuals with strong leadership and supervisory skills, and with experience participating in or leading multi-functional project teams are encouraged to apply. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. ______________________________________________________ Apply on company website Scientist/Sr. Scientist, Immunology Genentech - US - California,South San Francisco

2/2/2014 26

Posted 3 days ago Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Scientist/Sr. Scientist (Department of Immunology) The Department of Immunology in Genentech Research is seeking a highly motivated Scientist /Senior Scientist to lead an effort in developing novel therapies for the treatment of various autoimmune diseases with unmet medical needs. The successful candidate will head a research group with the mission to identify and pursue therapeutic ideas. The candidate will also lead the effort to translate these ideas to therapeutic approaches for clinical development through the collaboration with other groups and departments,. In addition, the candidate will perform cutting-edge research in immunology to discover novel pathways and mechanisms that contribute to the pathogenesis of diseases and will publish impactful papers on this research. Who You Are A PhD, MD, or MD/PhD and post-doctoral training or equivalent experience in immunology, molecular biology, or cell biology is required. A minimum of 5 years of research experience in immunology with demonstrated academic achievement, as evidenced by publications in high impact journals, is required. Additional experience in mucosal biology, in vitro study of primary cells, or the biochemistry of signaling cascades, is encouraged. The candidates should also have strong communication skills and evidence of dedication to translating basic research insights into therapeutics. LI-KD1 The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. ______________________________________________________ Apply on company website Principal Scientist/Staff Scientist, Immunology Discovery Genentech - US - California,South San Francisco Posted 1 day ago Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position The Discovery Immunology department is seeking an exceptional and highly motivated scientist to join a team focused on the discovery and clinical translation of novel drug targets for autoimmune and inflammatory diseases in the Genentech Research and Early Development organization. He/she will in collaboration with the Senior Director of Immunology Discovery work to identify and

2/2/2014 27

successfully initiate new innovative strategies for drug target discovery and new therapeutic area programs. Who You Are The Principal and Staff Scientist are the most senior levels in the Scientist track. A Ph.D. plus 12+ years of relevant combined post-doctoral and independent research experience in the immunology field is required. It is expected that the applicant will have demonstrated a sustained record of productivity and impactful scientific contributions as determined by consistent publications in high-impact journals. The successful candidate will have a demonstrated record of people management and outstanding communication skills. Preference will be given to individuals with a background in mucosal immunology and/or tolerance. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. ****************************************************** Apply on company website Senior Research Associate I, Biology Gilead Sciences - Fremont Posted 6 days ago Job description Seeking a highly-motivated, team-oriented research associate to join our in vivo cardiovascular pharmacology group. Daily responsibilities include conducting in vivo cardiovascular efficacy studies, including but not limited to perform experimental procedures in small animal models of arrhythmias or other cardiovascular diseases, assessment of cardiovascular function, routine dose administrations, tissue and blood sampling and data collection and analysis. Desired Skills and Experience The candidate should have good understanding and knowledge of integrated physiology and/or pharmacology, be able to accurately interpret their own study results. The candidate must have hands-on experience in performing in vivo experiments, preferably with animal models of cardiovascular diseases. Experience in developing or using small animal models of arrhythmias (particularly atrial fibrillation) is preferred. Candidate should have excellent technical trouble-shooting, problem solving capability in the lab and be able to work independently with minimal supervision to generate high quality experimental data. Basic computer skills in word processing, spreadsheet and graphing software to prepare reports, data spreadsheets, and data analysis are required. In addition, the candidate is expected to have multi-tasking/ sound time management and good communication skills. BS/MS degree in life sciences including pharmacology, physiology, biochemistry, or related fields, with at least 3 years of relevant working experience. Gilead Sciences was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. **************************************************************************** http://www.linkedin.com/jobs2/view/10637535?trk=job_view_similar_jobs Research Scientist: Immunology/Biochemistry/Cancer Biology/Immunopathology Diagnostic BioSystems - San Francisco Bay Area Posted 3 days ago

2/2/2014 28

Job description Diagnostic BioSystems is a growing biotechnology company focused on developing, manufacturing and marketing immunohistochemistry reagents for Anatomical Pathology market. We are looking for a full time PhD level scientist with a strong background in tissue based immunostaining. Prior experience in the field of immunohistochemistry, tissue sectioning and immunostaining is a must. Candidate must have the ability to read the slides and troubleshoot the staining. A strong background in cancer research is required. Experience in monoclonal and polyclonal antibody production, purification and characterization, protein modification and conjugation, tissue culture, Western Blot, ELISA etc. will be a plus. Strong organizational and communicational skills are required. Candidate must have prior experience in field of Anatomical Pathology market. Desired Skills and Experience Candidate must be able to wear many hats, as we are a small but growing company with tremendous future growth potential. Job responsibility includes;

• Expanding our current line of Multiplex Reagents and antibodies, including antibodies for clinical and research application as well as reagents for immunohistochemistry.

• Overseeing new product development and technology transfer in accordance with FDA and ISO standards

• Experience with automatic IHC stainer platform protocol will be a plus. • Facilitate new processes, tools, communications, training, technical designs and methodologies to

ensure success • Troubleshoot experiments to identify problems. Maintain project schedules by implementing

solutions and deadlines. • Demonstrated strong leadership in the team environment. Effectively collaborated and

communicated with multiple project teams/functional areas. • Sound knowledge in computer skills required. Must know MS office, Photoshop, presentation tools

as well as public databases (NCBI, Ensembl etc.) • Candidate must have excelled in experimental design, analysis of data and literature as well as

collaborations with professionals in different fields and in problem solving skills. Diagnostic BioSystems is a leading developer of specialty Immunohistochemistry reagents. The company is dedicated to high quality antibody production and development of novel multiplex staining reagents. Building on its strong global presence, Diagnostic BioSystems produces novel, clinically relevant tools for pathology market including: monoclonal and polyclonal antibodies, a wide range of detection systems and ancillary reagents for high quality immunostaining. Custom Monoclonal and Polyclonal Antibody Production Services include peptide synthesis, in vitro and in vivo antibody production, purification and conjugation. Diagnostic BioSystems is an FDA registered medical device manufacturer, operating under FDA 21CFR Part 820 Quality System Regulations and certified under ISO 9001:2000 Quality Management System International standards, manufacturing CE marked medical devices, for use in the European market. ******************************************************************************* Apply on company website Principal Scientist - Protein Purification Merck - Palo Alto, CA, US Posted 3 days ago Job description Principal Scientist - Protein Purification-MOL000293 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

2/2/2014 29

We are looking for an experienced hands-on manager in protein purification to join the Protein Sciences group at the Merck Biologics unit in Palo Alto. The successful candidate will manage a group of four scientists (including one PhD-level scientist) to purify and characterize a variety of reagent and therapeutic candidate proteins including tagged and untagged proteins, monoclonal antibodies, and antibody scaffolds. The protein purification group generates micrograms to multiple grams of purified proteins/antibodies. Candidates must have solid, proven experience in all aspects of protein purification and purification process development for early stage protein therapeutics. The successful candidate will be expected to demonstrate technical leadership in the laboratory, oversee and delegate experimental/project responsibilities, independently champion technology development projects, be involved in new product evaluation, and definition of process platforms. The candidate is also expected to work at the bench as needed (up to 50% of the time). The candidate will work collaboratively with the protein expression and protein analytics teams to design and execute experiments supporting process definition, optimization and scale up. Candidates must have deep and broad knowledge of protein analytical technology including chromatographic and biophysical characterization methods such as HPLC (SEC, IEX, RP), capillary electrophoresis, IEF, dynamic and static light scattering. The candidate will be in charge of establishing a high-throughput protein and antibody purification platform to support antibody discovery, optimization, and technology development. Experience with automation is a plus. The candidate will be also managing some protein production projects at various CROs. This individual is expected to be a critical member of the Biologics Discovery team and will be required to efficiency plan and execute cross-line collaborations as well as execute on advanced innovative scientific approaches. He/She will contribute to defining expertise-related aspects of overall program goals. Qualifications Education: * PhD, preferably in related field, with at least 8 years of post-doctoral experience in in protein purification and analytical characterization or a MS with at least 10 years of experience in protein purification and analytical characterization or a BS degree with at least 14 years of experience in in protein purification and analytical characterization. Required Skills: * At least 5 years of experience as manager of a protein purification group in an industry setting. * Skills in managing, mentoring and developing scientific staff. * Extensive and proven theoretical basis and hands-on experience in protein purification and analytical characterization * Technical expertise with automation and high-throughput research processes is highly valued. * Strong understanding of the biotech industry needs in terms of product quality and process-flow. * Initiative to drive projects and deliver results on time * Excellent written and verbal communication skills are essential

2/2/2014 30

* Strong organizational skills * Committed to working synergistically and harmoniously with others Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. Search Firm Representatives - Please read carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes ted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Merck is an equal opportunity employer, M/F/D/V – proudly embracing diversity in all of its manifestations. Former Military, Transitioning Service Members, National Guard & Reserves - We value your past and present service. Job: Molecular Discovery - Biologics Job Title: Prin. Scientist, Molecular Discovery Primary Location: NA-US-CA-Palo Alto Employee Status: Regular Number of Openings: 1 Hazardous Materials : n/a *********************************************************************************** http://www.linkedin.com/jobs2/view/10644874?trk=eml-anet_dig-b_premjb-ttl-cn Purification Lead (Biotech/Life Sciences) AnaSpec - San Francisco Bay Area Posted 2 days ago Job description The Purification Lead will be responsible for handling all peptide purification techniques and be accountable for managing a team of chemists. This position provides technical training experience to their team and others. Familiar with standard concepts, practices, and procedures in proteomics and genomics. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under general supervision. A certain degree of creativity and latitude is required. This person will report to the Director, Peptide Department. Desired Skills and Experience This position involves the following:

• Mass-directed HPLC analysis and purification • Method development • Train and assist team members. Create a knowledge-sharing environment so everyone on the

team learns and grows with the Company • Adhere to Standard Operating Procedures

2/2/2014 31

• Following and ensuring strict safety procedures and safety tasks required • Ability to produce and maintain good written documentation of experiments Specific Responsibilities:

• Follows protocols, designs, sets-up and conducts basic experiments • Performs sample prep, instrumental analyses and compound purification including through mass-directed HPLC • Analyzes and troubleshoots methods and data obtained from individual experiments • Recommends alternatives and suggestions to improve processes, validity and/or accuracy • Maintains and troubleshoots instruments, equipment and general lab areas if needed • Maintains detailed records of results which may include collecting, extracting and entering data via both electronic

and paper files/notebooks • Manipulates, interprets and/or presents results; prepares charts and graphs for presentations and publications as

needed • Tracks and summarizes lab supply expenses; orders and maintains inventory of reagents, lab supplies and

consumables and requests quotes for external vendors and verify accuracy of invoices Minimum Qualifications/Competencies:

• M.S. in chemistry or related field of study or B.S. in chemistry or related field with at least 2 years practical lab/bench experience is required

• Experience in HPLC method development and/or mass spectrometry • Hands on experiences on peptide purification techniques as follows: HPLC, dissolution, lyophilization, and

general wet chemistry experience such as: reversed-phase chromatography, ion-exchange chromatography, and size exclusive HPLC

• Current analytical methodology experience with HPLC and Mass Spectrometers • Excellent oral, written communication, and reporting skills

Personal skills • Goal oriented and solutions driven • Comfortable working in a fast changing, uncertain emerging market segment. • Ability to prioritize work and be expert in developing, presenting and achieving buy-in of new ideas • Familiarity with working with multi-national companies is a plus. • Team player and self-motivated

AnaSpec, Eurogentec Group is a leading provider of integrated proteomics and genomics solutionsTM for worldwide life science research. AnaSpec offers expertise in peptides, detection reagents, antibodies, assay kits, amino acids, oligonucleotides, and qPCRs. AnaSpec carries a broad product line of biochemicals and reagents for basic research, high-throughput screening and drug discovery. AnaSpec also provides premier custom services including peptide synthesis, antibody production, assay development, fluorescent dyes, and oligonucleotide synthesis. AnaSpec is certified to ISO 9001:2008.

**************************************************************************************************************************************** Contact: jobs@clinovo.com for more information. Must be able to work in the US immediately

Contract opportunity in the SF Bay Area for a Sr. CRA. 3-5 years’ experience needed. Leslie KolmanBiotechnology Staffing Specialist at Clinovo

Responsible for Clinical data review of data listings and summary tables, including query generation. Responsible for review or approval of IP release packages. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures. Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate. Strong computer skills (MS Office); with working knowledge of FDA & ICH/GCP regulations and guidelines.Thorough knowledge of clinical monitoring procedures and strong analytical and assessment skills needed.

2/2/2014 32

*****************************************************************************************************

Looking for SAS Clinical Programmers with 5+yrs of experience in US. Location: NJ/ Remote/SF Bay Area/MA. If interested send resumes at jessica@bodhisol.com

Jessica BodhiAccounts Manager at Bodhi Global Solutions LLC

*

***********************************************************************************************************

Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://www.jgbbiopharma.com/jobs-category/clinical-jobs

Clinical Trial Manager – Contract or Full Time (San Francisco Bay Area) PPBI

Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc. To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met for a Phase 1 oncology trial • Serves as primary contact for functional area representatives in managing the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments. • Oversight for forecasting of clinical supplies • Manage study milestones to ensure accurate tracking and reporting of study metrics. • Manage trial-specific collaborations with other research entities. • Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution. • Create and manage clinical trial budgets and staffing/resourcing plans. • Provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate. • Manage adherence to ICH/GCP/local regulations. • Participate in clinical operations initiatives and programs as assigned and other duties as assigned. • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork. • Other duties as assigned. EXPERIENCE AND QUALIFICATIONS: • Broad and current knowledge of regulations, clinical development process and therapeutic area to study plans. • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met. • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate. • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management. • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology. • Excellent organizational and negotiation skills. • Proven ability in creative problem-solving and possess sound judgment. • Team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners. • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook. • Working knowledge of MSProject for development and update of clinical study timelines. • Willing to travel – anticipate 25%.

2/2/2014 33

• Bachelor’s Degree with 8+ years of clinical research experience.

__________________________________________________________________________

Clinical Consultant (24 to 40 hrs/ week) Long Term Contract – Contract to FTE (San Francisco Bay Area) PPBI Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Work directly with the Medical Director at a well-funded pre-IND start-up to initiate the first clinical study (Phase I / 2A) • Select CRO and study s • Support the writing of the investigator brochure and protocol • Develop budget and timeline scenarios and a clinical project plan • Manage more junior clinical operations consultant(s) EXPERIENCE AND QUALIFICATIONS: • Knowledge of GCP and ICH guidelines required • Proficiency in the implementation, monitoring, and management of clinical trials • Able to work collegially within a team and carry out duties/responsibilities with general instructions • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project • Must be willing to travel occasionally (this is an in-house position so very little travel is required) • Previous experience as the lead clinical operations member • Clinical study start-up experience is required • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities. • Bachelor’s Degree in a relevant scientific discipline or equivalent • At least 7 years of relevant clinical experience in the pharmaceutical industry or equivalent with 7+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 3 years prior experience as an Associate Director Clinical Operations or higher level • 1+ years managing staff/direct reports. • Must be hands on and used to a start-up environment

*************************************************************************

Contact: Jay

Note: Candidates with experience in AKTA and unicorn software highly preferred. Please send your resume to: jay.surya@makroscientific.com

Research Assistant, Contract Employment Makro Scientific: Life to Life for Better Life. Makro Scientific: Staffing Specialist in Clinical and Scientific. Job Order:LJS-35033; Job Title: Research Assistant; Duration: 4 Months; Location: South San Francisco, CA;

2/2/2014 34

Description: Duties associated with this position are: protein purification utilizing GE's AKTA platform systems, running of SDS-PAGE gels, protein concentration, dialysis and characterization, lab notebook upkeep, online database upkeep. Job Requirements: This is a temporary employment position in a protein purification laboratory in the department of Protein Chemistry. We are looking for an individual who is eager to learn and implement various protein purification methodologies, someone with high level of organization, scientific interest and, most importantly, scientific integrity. As we are a large team, strong interpersonal and communication skills are also a must. Buffer production and handling, SDS-PAGE, PC and Mac operating systems. Candidate with expertise in Protein affinity and size exclusion chromatography, method development using GE's Unicorn software are highly desired Qualifications: BA/BS/MS with equivalent experience.

****************************************************************************************************** Evans Aguilar | Recruiter Legacy MedSearch Evans@LegacyMedSearch.com Reply with Resume if interested. I'm working with a Medical Device Manufacturing Company looking for a Director of Quality in the Tennessee area. A strong candidate will be one managing from the floor level to the board level, and sees challenges as opportunities for improvement. High volume manufacturing experience is a must. The ideal candidate will be a change agent who has experience guiding folks through events such as aquisitions, plant relocation, etc. ISO 13485 experience required. Is there anyone that you can recommend, if not yourself? ********************************************************************* Please email wirth@wirth-associates for detailed job descriptions. Posted by Summer Lake Wirth & Associates wirth@wirth-associates.com Director, Scientific Support & Education West Coast Responsible for leading the global strategic direction of the customer facing Scientific Support teams, as well as the Education Services team. Typically this will include responsibilities for leading phone/field applications support functions, course development, customer training, technical training, overall Sales &

2/2/2014 35

Services talent management and will have indirect responsibility for worldwide science support and education standardization. Plant Manager - J03-1009-T13 Northeast Manage, plan, direct, and coordinate the general operations of the solid dose, generics, manufacturing facility. Senior Management experience is required. Hands On - Pharmaceutical manufacturing experience is required. Current 10+ years, Solid Dosage experience is required. Sr. Director Hardware Engineering - 88-112113-54B CA The Sr. Director Engineering manages and leads the following functional R&D groups: Mechanical Engineering, Engineering Technical Services, Fluid Management Systems Engineering, Reliability Engineering and Electrical Engineering. Regional Business Manager The Regional Business Manager leads a US-based Regional sales team. This role is accountable for the attainment of sales goals in line with business strategy with the goal of attainment of budget for all territories within the region. Sales Consultant Sales Consultant to represent the Medical Surgical product portfolio to the US Medical/Hospital healthcare market segment. Primary responsibilities meeting/exceeding sales budget for territory. Sr. Product Technical Support Manager - 76-012014-64B CA The Sr. Product Technical Support Manager is responsible for setting strategic direction, as well as managing the activities of the Product Technical Support Sustaining Support, New Product Introduction, Technical Training and Technical Publications teams. Director Facilities - 22-112113-89B CA Direct Responsibility for Facilities Management, including project management, maintenance, cafeteria services, and security services. Includes responsibility for budgeting, vendor management, occupant moves, safety for contractor and facilities personnel. Director, Manufacturing - 66R-112013-59N Northeast Manage all aspects of clinical and commercial parenteral drug product filling, labeling and packaging operations for fully integrated biopharmaceutical company. Experience and Required Skills: Requires minimum BS/MS in a scientific discipline with 10+ years of related experience in a biopharmaceutical cGMP environment. Field Service Engineer - 21B-112013-87B CO - CA - UT - WA

2/2/2014 36

Responsible for providing on-site support to . customers that includes, but is not limited to: installation and service of diagnostic instrumentation, after-hours phone support, holiday and weekend on-site support, marketing, exhibitions, and clinical trials support. QC Lab Manager - 88J-120313-66C Rapidly-growing OTC drug firm seeks an experienced Lab Management candidate to oversee all microbiological and chemistry product testing to include raw materials, in-process, finished products, stability, methods development/validation, CAPA's, investigations, and allied areas. Validation Manager - -76-120913-45C South Central This person will oversee all aspects of sterile drug manufacturing validation to include process, water, manufacturing/packaging, HEPA filtration, CIP, SIP and allied areas. STATISTICAL QUALITY ENGINEER - 87J-1212213-74 South Central US This individual will act as a plant resource to create and maintain processes for statistically evaluating quality systems. VALIDATION ENGINEER - 14-011014-00J Midwest We are seeking a qualified Validation Engineering professional for a large solid-dose manufacturing operation in the Midwest. Qualified individual will have experience in Utilities (Clean Steam,Purified Water, Compressed Air, HVAC), Equipment Qualification and Cleaning Validation to include establishment of cleaning limits and calculation of product contact surface areas. MANAGER OF PRODUCTION MAINTENANCE - 76-J0122114-77C South Central This individual will manage a diverse maintenance organization to support sterile drug manufacturing with one of the world's largest Pharmaceutical companies. ********************************************************************************** Apply on company website Director, Business Development (Ph II-IV)-California/Bay Area Pharmaceutical Product Development, Inc. - US-California-San Francisco Posted 17 days ago

Job description Description The Director, Business Development will secure and retain business for PPD through professional, consultative, proactive sales activities directed at decision makers and decision influencers at existing and new sponsors. Oversee the sales activities (including, but not limited to cold calling, proposal writing, contract negotiation, sales presentations, support of client relations). Director will position PPD as a primary or preferred provider for all Phase II-IV Clinical Development Services to be outsourced. **Strong preference for a candidate based in the SF Bay area**

2/2/2014 37

Qualifications Education and Experience:

• Bachelors degree in science or business • 5 years sales experience including prior CRO sales experience in Phase II-IV clinical services • Solid understanding of clinical drug development industry, specifically in Phase II-IV • Or equivalent combination of education, training and experience that provides the knowledge, skills and

abilities to perform the job Knowledge, Skills and Abilities:

• Computer skills to handle sales automation, word processing, spreadsheets, power point and email • Excellent oral and written communication skills • Ability to manage people and tasks • Problem solving • Sales skills • Contract negotiation skills

PPD is an equal opportunity employer, M/F/D/V – embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military & transitioning service member’s service. PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 45 countries and more than 11,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.

*************************************************************** Jobs That Crossed My Desk Through Jan. 19, 2014

******************************************************************************************************************************

http://www.linkedin.com/jobs2/view/9348286?trk=rj_em

Sr. Product Manager--Genomics Real Staffing - San Francisco Bay Area Posted 2 days ago

Job description We are looking for someone to join our high-performance Genomics team that develops vibrant and profitable product offerings. Your focus will be on the cytogenetics space, managing the market leading CGH product line. Key Responsibilities: -Strategically evaluate new product opportunities and identify synergies with other products - Develop and execute portfolio product marketing strategies to achieve stated revenue, profitability and market share objectives -Develop novel product launch strategies and implement launch plans -Define pricing strategy, product positioning and configuration to ensure the best possible performance versus business goals -Set product-pricing strategies including discount structures, and manage those strategies in conjunction with market dynamics and target markets

2/2/2014 38

-Collaborate with cross-functional partners from other groups including marketing from other business units, R&D, manufacturing, and sales to achieve business objectives - Work with KOLs to drive market penetration in specific application areas - Work with marketing communications professionals to develop programs and collateral materials for products on the market - Define training and content requirements for products and programs - Drive the product/marketing message through all communication channels - Participate in key sales situations for the product.

Desired Skills and Experience Requires: - BS in biology, biochemistry, molecular biology; related discipline or equivalent. Master or Ph.D. preferred. - 8+ years experience in marketing life science products. - Experience in molecular diagnostics or regulated environment. - Experience with diagnostic products is important to be successful in this role. - Demonstrated use of marketing skills and market knowledge to define and commercialize products that result in business success - Experience in working with worldwide customers and is a strong advocate for customer focus and customer driven development - Demonstrate ability to develop marketing plans that align with strategic objectives - Ability to work independently to plan, prioritize workload, schedule time, assess and solve problems - High proficiency in pricing and forecasting - Must exhibit strategic thinking, teamwork, creativity, planning and organization, and flexibility - Strong analytical and decision making skills - Experience in working with global markets/customers an advantage - Excellent written and oral communications skills and comfortable presenting to high level audiences both internally and externally - Must have flexibility in working hours and available for 25% business travel Real Staffing is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services and has one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time. At Real Staffing we offer retained search as well as contingency recruitment within both the contract and permanent markets. Our consultants are market specialists and it is this in-depth market knowledge that allows our consultants to develop tailored recruitment solutions for this demanding recruitment market. We take the time to understand our candidates' current and future ambitions and actively seek out roles that will help take our candidates to the next level in their career. The strength of our client relationships and global network means we can access the best new roles within the sector. Whether you are looking to strengthen your team or looking for your next career move contact us today. www.realstaffing.com

**********************************************************************************************

Apply on company website

Director, Commercial Planning and Operations – Oncology Gilead Sciences - San Francisco Bay Area Posted 3 days ago

2/2/2014 39

Job description The Director CP&O will be responsible for global commercialization activities supporting oncology (85%) and inflammation (15%) molecules. Current pipeline molecules include:

• Idelalisib a PI3K-d inhibitor (GS-1101) currently in phase III for indolent non-Hodgkins lymphoma and chronic lymphocytic leukemia

• Momelotinib a JAK inhibitor (GS-0387) in phase III for myelofibrosis • GS-9973 a SYK inhibitor in phase II for B-cell malignancies • Simtuzumab (GS-6624) an antibody targeting LOXL2 in phase II for myelofibrosis, pancreatic and colorectal

cancers • GS-5745 an antibody targeting MMP9 in phase I for pancreatic, non-small cell lung and gastric cancers

This position will report directly to the Therapeutic Area lead for oncology and hematology. Three major responsibilities include, but are not limited to: 1) Support global commercialization efforts for at least one Phase 3 oncology molecule. High-level activities include development of molecule-specific global commercial plan, leading global launch planning including all aspects of branding and campaign development. 2) New Product Planning for the Gilead MPN, solid tumor and inflammation portfolio. This activity requires ability to integrate and influence at a project team level with individuals that represent key functional areas across the organization. This individual will need to demonstrate a strong ability to mobilize a global organization and operate effectively in a matrix team environment. 3) The role is also accountable for commercial assessments to inform decisions at IND, P1, P2 and P3 development milestones as well as providing strategic input and commercial assessments for corporate development activities in oncology and inflammation therapeutic areas. The Director CP&O will be expected to gather input from and provide strategic information to business partners and key stakeholders across the global organization to aid in the overall commercial planning and tactical execution. The Assoc. Director will work closely in collaboration with multiple functional leaders, Project Team Leaders, Regional Business Leaders, US Commercial, Pricing Strategy Leads, Medical Affair Leads, Market Planning, Competitive Intelligence and Clinical Teams to ensure molecule strategies and commercial assessments reflect US and affiliate strategic objectives. In addition this role will be responsible for executing appropriate activities in collaboration with functional partners to ensure that goals are achieved. Incumbents in the Director role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the business conduct of Gilead. Incumbents in the Director CP&O role are generally expected to:

• Demonstrate significant leadership skills, business knowledge, analytic and strategic agility, high-level of collaboration, ability to mobilize an organization toward a common goal, and effective communication and presentation skills.

• Responsible for providing strategic and tactical inputs into Gilead oncology business planning and review processes, e.g., Commercial Strategic Plans, Tactical 1 Year Brand Plans, Global Launch Plan and Affiliate Specific Plans.

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Work collaboratively, effectively and efficiently with all internal and external partners and stakeholders. Includes acting effectively, where applicable, as Gilead co-developed with external partners.

• Support his/her manager in a variety of departmental leadership projects and endeavors, e.g., training and development programs for departmental staff, new templates or other tools for departmental work, taking a leadership role in special projects, etc.

• Supports and, if needed, represents the respective project teams for business related issues at meetings with Sr. management across the global organization.

• Serves as key communication and knowledge transfer link between all key stakeholders within the organization.

2/2/2014 40

Director, CP&O Oncology/Inflammation is based in Foster City. Travel is required.

Desired Skills and Experience Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements. QUALIFICATIONS & EXPERIENCE:

• Bachelors Degree (Marketing, Business Management, or Science discipline is a plus) • MBA or other related graduate-level degree is preferred (Master’s or Doctoral degree in a life sciences field is a

plus) • 4-6 years or more previous experience in marketing, market research, competitive intelligence, business

development, field sales, or managed care in the pharmaceutical/biotech/or other related industry, with at least 3 years’ previous experience in marketing

• 1-3 years new product planning preferably global in scope • Launch experience is highly preferred • Previous experience in leading the development and implementation of brand/product strategy and vision

required • Demonstrated ability to lead development and execution of complex plans across multiple priorities • Must demonstrate some past experience with, and knowledge of, the drug development process (pre-clinical and

Phase I – III); has worked on core team/project team related projects • Must demonstrate strong knowledge of product development, regulatory and clinical affairs • Must demonstrate previous experience in, and strong abilities for, establishing relationships with key opinion

leaders and other relevant, external influencers • Must demonstrate strong knowledge of message development and clinical publications’ planning • Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as

qualitative goals • Previous experience in completing & implementing business plans • Must demonstrate strong skills in building team and collaboration • Business travel, by air or car, is required for regular internal and external business meetings

ABILITIES:

• Impeccable ethics and integrity • Ability, comfort & commitment in/to operating in a highly regulated environment and industry, which requires

understanding of the imperative for compliance with company policies, procedures and other relevant internal or external laws and regulations

• Demonstrable abilities to manage more complex marketing responsibilities, to include integration across multiple projects and activities

• Has sufficient strategic agility capable of assessing marketplace, product-specific and financial data and translating this into meaningful, appropriate and executable marketing opportunities & plans

• Financial acumen; able to create & perform more detailed and sophisticated financial modeling to support or refute recommendations & plans

• Demonstrable abilities to oversee the work of other team members and ensure the highest standards, efficiencies and overall effectiveness

• Can motivate & inspire others • Demonstrable track record of creating innovative/breakthrough marketing strategies for products in the

pharmaceutical/biotech/or other related industries • Exceptional organizational skills • Outstanding communication, presentation & facilitation skills, able to tailor presentations to different audiences

across the organization • Strong influencing & negotiation skills; proven abilities to influence others without authority

2/2/2014 41

• Strong customer orientation/focus

*********************************************************************************************

Send resumes to pharmacontractjobs@gmail.com

Scientist position in Los Angeles, CA - 1 year+ contract with a big pharma

Jennifer CapelliPharmaceutical Recruiter The Scientist will be responsible to develop, validate, transfer and troubleshoot Analytical test methods. He/she is responsible for performing Analytical out of specifications/out of trend (OOS/OOT) investigations, non-conformances, test method development, test method validation, test method transfer, stability, and technical troubleshooting. The individual will manage the workload to meet the aggressive timelines and have strong written and verbal communication skills. In addition, he/she is responsible for following all internal policies and procedures; author all pertinent data and documentation; and complete all necessary testing, while maintaining the necessary cGMP compliance requirements. Qualifications A minimum of a Bachelors degree with minimum 5 years of professional experience is required. Additional requirements: 1. A strong working knowledge of Analytical test methods development, validation, and transfer per ICH requirements 2. Experience and working knowledge of HPLC, wet chemistry and compendial techniques 3. Must have excellent working knowledge of Empower, strong knowledge of cGMP requirements and have excellent documentation and communication skills. ********************************************************************************************************************************* Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://jgbbiopharma.com/jobs-category/biostatistics-data-management-related-jobs

Senior Biostatistician – Full Time Position (San Francisco Bay Area) PPBI

Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc. To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Collaboration with clinical scientists on protocol design (author statistical methods section and generate study randomization) • Generate statistical analysis plan for assigned protocols (incl. Mock displays) • Assume responsibility for individual studies, write statistical portion of integrated clinical/statistical reports • Work with SAS programmer to develop statistical programs to perform analysis, prepare data displays, verify data accuracy and validity • Supply statistical input for NDA submissions and in response to FDA queries • Provide support for investigator publications

2/2/2014 42

• Review case report forms, data management plan, and monitoring plan to ensure that protocol objectives are met and project standards are maintained EXPERIENCE AND QUALIFICATIONS: • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials. • Experience with SAS. • Strong interpersonal and effective communication skills • Pharmaceutical industry experience required. • NDA submission experience required. • Global submission experience is a plus • Education Requirements (degree, certifications, etc.): • Ph.D. in Biostatistics or closely related discipline with a minimum of 8 years experience in pharmaceutical and biotech industry _________________________________________________________________________________

Statistical Programmer III – Full Time Position (San Francisco Bay Area) PPBI

Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc. To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures. Key Accountabilities/Core Job Responsibilities: • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data. • Create CDISC SDTM and ADaM files and SAS export files to use for Electronic Submission from the data received in non-standard form from various sources. • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. • Review Data Management Plan, Data validation plan and edit check specifications • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements. • Recognizes inconsistencies and initiates resolution of data problems. • Acts as a liaison between statistical programming, subcommittees and project teams as needed. • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles. • Acts independently to determine methods and procedures on new assignments. • May provide guidance to other lower level personnel. • Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices. • Validate work of other programmer/analysts at CRO or in-house. • Maintain complete and auditable documentation of all programming activities. • EXPERIENCE AND QUALIFICATIONS: • Ability to use professional concepts to achieve objectives in creative and effective ways. • Experience in the analysis of Oncology clinical trial data a plus. • Knowledge of CDISC standard (SDTM & ADaM) a plus. • Minimum 5 years Pharmaceutical/Biotech programming experience. • NDA submission experience is a plus • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros,

2/2/2014 43

SAS/Graph and SAS/Stat. • BS in Statistics, Math or Scientific Discipline.

__________________________________________________________________________________

Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) PPBI

Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc. To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices. Key Accountabilities/Core Job Responsibilities: • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established procedures and policies. • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF). • Develops, implements and maintains CTMFs for all clinical trials. • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents. • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and procedures and processes. • Manages and controls the paper-based CTMF storage room and its contents. • Manages and controls the eCTMF storage and maintenance systems. • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and procedures and processes. • Develops and manages the archiving systems and retrieval of archived CTMF documents. • Functions as the Subject Matter Expert for CTMF document management systems and processes within • Provides CTMF support and guidance for internal and external CTMF audits. • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections. • EXPERIENCE AND QUALIFICATIONS: • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs. • Excellent working knowledge of current electronic CTMF systems and standards. • Ability to analyze and reconcile complex issues independently. • Ability to independently and effectively manage assigned task and projects. • Ability to lead and manage CTMF support personnel. • Ability to develop or update Standard Operating Procedures and Work Instructions. • Excellent verbal and written communication and interpersonal skills. • Must be an individual with proven initiative and demonstrated ability in a fast paced environment • Established experience and knowledge of general CTMF systems and standards. • Established experience and knowledge of paper-based document CTMF systems. • Established experience and knowledge of electronic CTMF systems. • Established experience providing CTMF support for US and Ex-US regulatory authority inspections • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements. • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite. • Established experience with design, development and implementation of a paper-based CTMF storage room. • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system. • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.

2/2/2014 44

• Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

__________________________________________________________________________________

Associate Director / Director Clinical Operations – Full Time Position (San Francisco Bay Area) PPBI

Margaret ImperialeRecruiting Specialist at JGB BioPharma Consulting Inc. To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Position reports to the VP Clinical Operations • Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical oncology trials. • Line management of CTA Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues. • Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project. • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs. • Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility. • Interact with study teams to ensure consistent functional performance and quality of work. • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables. • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed. • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials. • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations. • Ensure effective and efficient collaboration between internal customers and external providers (CROs). EXPERIENCE AND QUALIFICATIONS: • Phase 3 experience required. • Line management experience required. • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must. • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate. • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment. • Demonstrated competency in leading cross-functional process improvement efforts. • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching. • Financial budgeting and resourcing planning skills. • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. • Knowledge of medical terminology. • Strong computer skills to include MS Office: Word, Excel and PowerPoint. • Excellent oral/written/presentation – communication skills. • Cross-functional and cross-cultural awareness • BA/BS or equivalent degree in life sciences or allied health field.

2/2/2014 45

• Minimum of 10 years experience in clinical operations roles, including at least 3 years of global clinical trial experience. Oncology indication experience required ***************************************************************************************************************

http://www.linkedin.com/jobs2/view/10199301?trk=rj_em

Director of Alliance Management Onyx Pharmaceuticals - San Francisco Bay Area Posted 3 days ago

Job description At Onyx, the Alliance Management ensures that the product-related partnerships Onyx has in place are functioning optimally and that Onyx establishes and maintains a reputation of being a capable, objective and preferred partner to other Pharma and Biotech companies. Alliance Management develops Onyx s best practices and approaches to manage partnerships and acts as a bridge between partners and the Onyx organization. Essential/Primary Duties, Functions and Responsibilities:

• Act as the primary point of contact for partners • Sponsor the transition phase from partnership or licensing negotiations to implementation of the partnership within

Onyx • Build and maintain strong and collaborative partnerships • Develop positive and strong working relationships; strive for frequent in-person interactions; active listening;

timely and pro-active issue resolution • Manage partners’ information requests; collect answers and respond to partner; issue resolution • Form a strong link with the respective functions/individuals within Onyx to ensure smooth operations of the

partnership • Work closely with all parts of Onyx’s organization to address partners’ needs; Proactively identify needs and help

organize/drive Onyx and partners towards mutually beneficial solutions • Maintain an organized record of exchanged information, agreements and action items • Contracts, meeting agendas, minutes, press releases, publications, etc.; database set-up and management • Drive resolution of conflicts, actively identify, support and sponsor opportunities to expand or reduce partnership

scope, negotiate changes to partnership agreements • Organize partnership governance meetings (e.g. Steering and/or Joint Development Committees), lead internal

Onyx pre-meetings to align positions and interests, chair or co-chair the meetings and issue agendas and minutes, and follow-up on action points

• Work with Law Department to manage legal agreements, including tracking of legal obligations • Perform database management to capture key partnership documents and actions; ensure cross-functional

implementation of contract • Transfer learnings and partnership best practices to new transaction negotiations and governance • Develop tools to assess the health of partnerships; manage partnership reporting to Management

Desired Skills and Experience Work Experience:

• A minimum of 10+ years of related industry experience • Broad cross-functional experience in Pharmaceutical/Biotech Industry • Prefer prior experience in Alliance management or related area • Previous exposure to senior management (presentations, proposals, etc)

Education/Training: • Bachelor degree; MBA or equivalent preferred

__________________________________________________________________________

http://www.linkedin.com/jobs2/view/10249736?trk=job_view_browse_map

2/2/2014 46

Director, Commercial Financial Planning & Analysis Onyx Pharmaceuticals - San Francisco Bay Area Posted 3 days ago

Job description The Director/Senior Director, Commercial Financial Planning & Analysis leads the Commercial Finance function and is responsible for all aspects of financial management, including decision support and stewardship of Onyx’s Commercial and Medical Affairs functions. The role has the opportunity to directly influence and contribute towards Onyx’s success in its mission to improve the lives of people with cancer and change the way cancer is treated.

• Lead Commercial financial planning and analysis function, including setting priorities for department and individual objectives

• Participates as a member of the Commercial Leadership Team • Lean financial analysis and management projects • Financial management and analysis to facilitate decision making in the Commercial and Medical Affairs functions • Coordinates development of the Commercial Long Range Plan across all franchises and territories for Onyx, in

support of overall Long Range Plan • Participate in the financial relationship with Onyx’s principal collaborators • Lead the preparation and analysis of collaboration financial plans • Prepare financial analysis and presentations as needed • Special projects and analytical support as needed

Desired Skills and Experience Requirements: Minimum of 7 years relevant work experience, with a Bachelor’s degree in Finance or related field. MBA and/or CPA highly desirable Functional/Technical Knowledge & Skills: High attention to detail, works accurately and quickly, and has good organizational skills

• Strong ability to partner with Commercial business leaders • Sharp analytical, finance, and accounting skills • Excellent communication skills, written and oral; Displays executive presence • Energetic, flexible team player, with the ability to adapt in a changing environment

Customer & Industry Knowledge: • Biotechnology or Pharmaceutical experience preferred

Education/Training: • Minimum of 7 years relevant work experience and an MBA

Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.

**************************************************************************************************************

http://www.linkedin.com/jobs2/view/10494195?trk=eml-anet_dig-b_premjb-ttl-cn

Director of Sales -Surgery Center McKesson - San Diego

Job description We are seeking a seasoned sales executive to work from home (virtual office) and travel 75% within the Western region selling medical supplies distribution into Surgery Centers. Prior experience selling into the OR (Operating Room) or Surgery Centers is critical. Region will consist of western region of California, Washington, Oregon, Nevada, and Idaho.

2/2/2014 47

Candidate will be located Southern California. Primary responsibilities as follows:

• Achieving combined Sales, Gross Profit and Gross Profit percent plan on all base business accounts and new accounts. • Responsible for favorable, corporate and field, business relationships and ongoing partner momentum at our Surgery Center

customers. • This position must support the Company's strategic plan for the accounts to ensure long-term Company goals aligned with the

current business plans and aggressively supports a profitable growth strategy. • Measure customer penetration, performance and margin contribution of programs and services in coordination with financial

guidelines. • Interface with CEOs, COOs, Vice Presidents and Directors from various departments within customer headquarters,

including Sales, Operations, Accounts Payable, Information Technology and Training/Development. • Work with manufacturing vendors to enhance portfolios, gain compliance, grow sales and enhance margin. • Perform Business Reviews with customers on a quarterly, annual and bi-annual basis expanding base business via product

line expansions, new market penetration, promotions and other growth drivers. • Establish, manage and monitor new processes to relieve or alleviate customer business concerns or work flow processes. • Establish ongoing performance requirements and ensure effective processes to monitor contract agreements to include service

levels, pricing, vendor agreements, and customer support. • Identify and target potential new accounts. Cold call and gain access to key decision makers. Partner with Account Managers

on target opportunities. • Present McKesson value proposition and negotiate agreements for new business opportunities. • Train and educate sales team on Surgery Center strategy, process and working elements.

Desired Skills and Experience Minimum Requirements (Must have to be considered)

• 5 years experience in field sales. Critical Skills (Must have all of the following skills to be considered)

• Field sales experience within the surgery center market • Proven experience selling to C-Suite executives • Knowledge / experience of the healthcare distribution business

Additional Knowledge & Skills (preferred but not required)

• Proven sales or sales management experience with demonstrated ability in corporate account, surgery center, or OR (Operating Room) sales.

• Demonstrated success selling to the C-Suite. Strong verbal and written communication as well as presentation skills. • Understand GPO's • Must be able to work effectively in a team environment. • Must be able to work with little supervision. • Basic computer skills including ability to effectively use the Internet, Microsoft Word, Excel, and PowerPoint, and Outlook. • Strong organization and time management skills; results oriented • Excellent communication and listening skills. • Must be able to work in a high energy, fast paced environment. • Must have strong executive level negotiation skills. • Must have a demonstrated track record of sales success. • Nurses or administrators with sales experience would be ideal. OR (Operating Room) sales such as Medical Device Sales

with experience managing National Accounts could be a fit as well. Education

• Bachelor's degree or equivalent experience Certifications/Licensure

• Must have valid driver's license in good standing Travel Requirements

2/2/2014 48

• Must have ability to travel by air and by car within the assigned region McKesson Corporation, currently ranked 14th on the FORTUNE 500 list, is a healthcare services and information technology company dedicated to making the business of healthcare run better. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit us at www.mckesson.com.

***************************************************************************************************************

http://www.linkedin.com/jobs2/view/10495216?trk=eml-anet_dig-b_premjb-ttl-cn

Quality Manager National Staffing Consultants - Temecula, CA Posted 1 day ago

Job description Quality Manager Temecula, CA We are excited to announce a NEW opening at our client in the Temecula, CA area. Please contact us TODAY to learn more. The QA Manager will be focused on managing and developing the Quality staff; as well as, implementing, monitoring, and maintaining the Quality system at the facility; and, will drive improvement activities including the maintenance of comprehensive quality metrics. This position will partner with the manufacturing organization and support teams to make recommendations, set goals, and implement solutions for process improvements. Provide overall guidance on quality as well ensuring business objectives are met. Ideal candidate will have a proven track record as a manager and for developing a staff of engineers in a Quality OR Operations function.

• Lead, manage and develop staff that supports the daily operations of the Quality department; and, establish partnerships with all other site department managers

• Manage QC test and inspection, in addition to other manufacturing support roles, as required • Manage and drive improvements of the quality management system (U.S. QSRs, ISO 13485 and ISO 9001) • Lead development and implementation of productivity improvements and cost saving initiatives that support

business objectives • Drive product improvements through investigations and root cause analysis; provide resolution • Develop and implement standardized metrics that guide actions and promote continuous improvement • Actively support Quality Management across the company by providing expertise and sharing of best practice • Ensure compliance to all corporate and divisional procedures and processes as well as those local SOPs and

work instructions that support these procedures

Desired Skills and Experience Requirements:

• BS degree or higher in a scientific discipline • 5-7 years experience in employee management and 3-5 years experience in leading a quality organization or regulated

department in a scientific environment is a MUST. • Industry experience must be within the life science space such as pharmaceutical, medical device or biotech. • Strong foundation in Lean Manufacturing and Continuous Improvement with Strong command of ISO 900, ISO

13485, and U.S. QSRs. • LSS Black/Green Belt a plus

2/2/2014 49

• CQE, CQA, or CQM a plus • Travel between sites may be required • Proven, strong leadership skills; partnering with the business to make things happen • Proven, problem solving ability with attention to root cause • Strong organizational and communication skills are a must • Team player attitude, ability to drive change, challenge the status quo • Interface with peers and colleagues internal and external to identify and implement best practice • Motivate and build a high performing team • Set ambitious and achievable targets to drive for results based on organizational objectives

Please note we have multiple quality roles open that vary in scope. Contact us today to learn more. Email : tarabenoit@national-staff.com National Staffing Consultants is a National Search Firm Serving the Life Sciences Industry. “You have the best recruiters I’ve ever worked with.” At National Staffing Consultants, we hear this compliment time again from our clients and candidates. So what makes us different from other search firms? As a boutique executive recruiting firm, we focus on job recruitment for the Biotechnology, Medical Device, and Pharmaceutical industries in Greater Boston, MA, New England, and throughout the U.S. We bring PASSION, DEDICATION and COMMITTMENT to our work. We delive at nothing less than 100% and have 20 years of proven success. See for yourself what clients and candidates have to say about working with the recruitment team at National Staffing Consultants. Contact us today! http://www.national-staff.com/contact-us.html OR http://www.info@national-staff.com

******************************************************************************* FIRST STEP IN PROCESS: Send me your resume greg.grichuhin@gmail.com Greg Grichuhin Sr. Recruiter Med Device Search Group Fremont, CA Sr. Manufacturing Engineer (Extrusions). Trouble shoot extrusion operations (small diameter catheters). IQ-OQ-PQ and validations. Leadership role with great company. Must be expert in polymers and materials. Compensation $100-120k - relocation provided _____________________________________________________________________________________ San Jose, CA Sr. Quality Engineer - Development. Company makes plastic injection molding parts and does assembly. Stents, Catheters, RF Ablation, Heart Valves. Multiple QA roles open here - both full time employee and contract roles. $100-125 _____________________________________________________________________________________ Fremont, CA Sr. Production Engineer - High and low volume manufacturing lines. Neurovascular products. Must have 4 year engineering degree and knowledge of six sigma. Manages group of 8-10 production workers. $90-105k. Locals preferred. ********************************************************************************************

2/2/2014 50

Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://www.jgbbiopharma.com/jobs-category/clinical-jobs

Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) Baybio Margaret ImperialeHuman Resources Coordinator at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: • Reports to Sr. Director Clinical Operations; position initially has no direct reports but may within a year • Manage Phase 2A to 2/3 oncology program including CRO’s and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines • Works closely and independently with the CMO and Medical Directors and represents clinical operations for this program EXPERIENCE AND QUALIFICATIONS: • Experience in Oncology required • Must be hands on and used to a start-up environment • Knowledge of GCP and ICH guidelines required • Proficiency in the implementation, monitoring, and management of clinical trials • Able to work collegially within a team and carry out duties/responsibilities with general instructions • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project • Must be willing to travel occasionally (this is an in-house position so very little travel is required) • Previous experience as with minimum title of SCRA • Study start-up experience is required • Global trial experience is desirable • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities. • Bachelor’s degree in a relevant scientific discipline or equivalent • At least 4 years of relevant clinical experience in the pharmaceutical industry or equivalent (SCRA) and minimum of 7 years for Clinical Program Manager title. • Must have 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment • Basic relocation provided _____________________________________________________________________________________

Engineering Technician – Contract (San Francisco Bay Area) Baybio Margaret ImperialeHuman Resources Coordinator at JGB BioPharma Consulting Inc.

To view job description and other current positions please visithttp://jgbbiopharma.com/jobs/. Interested parties should contact/send resume to Margaret@JGBBioPharma.com. No Work Visa sponsorship is available for this position. DESCRIPTION: ♣ Operate semiconductor chip testers screening good and bad chips. ♣ Touch screen GUI operation. ♣ Run experiments and collect data on our chips in collaboration with engineers. ♣ Handle incoming chip shipments, test and inventory. ♣ Prepare prototype and production chips for shipment. EXPERIENCE AND QUALIFICATIONS: ♣ Excellent Lab organization and management skills.

2/2/2014 51

♣ Focus important. ♣ Experience operating typical semiconductor test equipment would find testers easier to use then the norm ♣ Familiarity with Linux and Windows operating systems. ♣ Soldering skills of SMT parts a plus (not required)2-5 years at an electronics/semiconductor company. ♣ 2-5 years at an electronics/semiconductor company. ♣ 2 year college electronics degree expected. ♣ Previous experience as a tech in a production capacity at a semiconductor company ideal. Margaret Imperiale Recruiting Specialist JGB BioPharma Consulting Inc http://jgbbiopharma.com/jobs-category/engineering-jobs

*****************************************************************************************Posted by Gennifer Vega To apply for a position send your resume to Jobs@JGBBioPharma.com Associate Director / Director Clinical Operations – Full Time Position (San Francisco Bay Area) R117GX DESCRIPTION: Position reports to the VP Clinical Operations Lead functional work process optimization, continuous improvement, and change management in

partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical oncology trials.

Line management of CTA Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed

Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.

Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.

Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.

Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility.

Interact with study teams to ensure consistent functional performance and quality of work. Strategically assess metrics and ensure implementation of appropriate measures as necessary to

support project or program targets / deliverables. Lead strategic planning and process development/ implementation for the function(s), tracking

timelines to remain on schedule, and developing contingency strategies, if needed. Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across

clinical trials. Lead/participate in meetings to plan and implement cross-functional operational activities to

increase quality, productivity, and efficiency within Clinical Operations. Ensure effective and efficient collaboration between internal customers and external providers

(CROs). Liaise with internal (Study Management, site contracting, Central Services) and external

(investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.

Collaborate and work effectively with other functional managers to establish high quality and efficient processes and ensure consistency and alignment throughout the team.

Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.

2/2/2014 52

EXPERIENCE AND QUALIFICATIONS: Phase 3 experience required. Line management experience required. Excellent people interaction and communication skills, strong professional diplomacy and positive

attitude a must. Ability to foster a collaborative team environment, motivate others, work in teams in a matrix

environment and with various levels both within company and with vendors as appropriate. Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-

task, re-prioritize duties, and work effectively in a fast paced matrix environment. Demonstrated competency in leading cross-functional process improvement efforts. Demonstrated leadership and management skills, prior supervisory experience with demonstrated

success in managing people, and expertise in mentoring and coaching. Financial budgeting and resourcing planning skills. Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology. Strong computer skills to include MS Office: Word, Excel and PowerPoint. Excellent oral/written/presentation – communication skills. Cross-functional and cross-cultural awareness BA/BS or equivalent degree in life sciences or allied health field. Minimum of 10 years experience in clinical operations roles, including at least 3 years of global

clinical trial experience. Oncology indication experience required Project Manager – Contract (Southern California) 73T6408 DESCRIPTION: Support the Market Development, Creative Services, Regional Marketing, and other users. Tasks include creating and updating training material, sending out relevant communications,

managing user questions and issues, and arranging scheduled training and orientation as needed. Determine additional system requirements based on business needs in line with evolving cross-

functional Marketing processes and industry standards. Partner with Marketing Systems owner and IT to prioritize and execute adaptations and

enhancements according to plans. Provide research and reports for leaders regarding the data Offer, as needed, analyses of contents and structure. Be capable of providing details and options for possible enhancements and solutions in response to

feedback and requests from users and leaders based on an ongoing assessment of system capabilities. May perform other related duties as required and/or assigned EXPERIENCE AND QUALIFICATIONS: This position functions as a team member, managing the training, support, and optimization of the

global campaign planning system. Effectiveness in this role requires a thorough working knowledge of the associated processes, tools

and systems as well as the department’s policies and procedures. The job encounters work situations of diverse scope and moderate to high complexity and

identifiable factors. Incumbent exercises judgment within defined procedures and practices to determine action. Requires solid communication and organizational skills to communicate and implement plans and

activities. Must have strong problem-solving and troubleshooting skills, especially as applied to cross-

functional logistics and computer software. Bachelor’s degree or higher in communications, marketing or a related discipline or equivalent

education and experience strongly preferred. Trainer – Contract (New Jersey) 6536 DESCRIPTION: Maintain quality standards and a state of audit readiness Develop and implement priority learning solutions that will support all learners with maintaining

compliance with company processes & procedures Creates and maintains 60 + Job Types and Roles in the Le@rn LMS

2/2/2014 53

Generates training compliance reports form Le@rn LMS Analyzes compliance reports, identifies gaps, escalates any potential concerns and ensures

corrective action in put in place Provide compliance reports as requested during internal & FDA Audits Interfaces with Functional Unit Training Leads throughout USMA and provide support and expertise

with Le@rn LMS Consults internal Quality Document author/SMEs and creates elearning modules using various

technologies i.e. Adobe Connect, Articulate, Brainshark, etc Consults internal Quality Document author/SMEs and instructor led training courses Manages the administration related to Le@rn LMS for USMA: ensure all USMA employees have a mandatory curriculum and determines necessary job type and

job role assignment create and maintain eLearning modules create and maintain prescriptive rules / training matrix monitors prescriptive rules to ensure system accuracy ensures all necessary R&D employees have access to USMA compliance training Monitors source data to ensure both employee and contractor Profiles in Le@rn are accurate Ability to pull information from multiple data sources and create custom reports using excel Monitors training compliance and escalates any issues Troubleshoot Le@rn LMS issues Manage the planning, implementation and close-out of learning events: course invitation,

conference room bookings and virtual training room set-up, provides user support for virtual classroom, provide on-site logistical support attendance tracking in Le@rn

Creates and Administers course evaluation via electronic survey tool Maintain training content (electronic and hard copy) Manage the mandatory Curriculum in Le@rn LMS including the creation and maintenance of

approximately 200 eLearning programs Manages the design, development, planning & implementation web based training courses Manages the design, development, planning & implementation for instructor-led learning events

(face to face and virtual participation) including training announcement/invitation, enrollment tracking, course confirmation and participation tracking in Le@rn LMS

Manages the technical application for all Adobe Connect Learning Events Manages and ensures accurate attendance tracking in Le@rn LMS Manage the planning, development implementation, close-out and evaluation of learning events: Assist subject matter experts with needs assessment, course design and development course

invitation, conference room bookings and virtual training room set-up, provides user support for virtual classroom, provide on-site logistical support attendance tracking in Le@rn

Administers course evaluation via electronic survey and produces report EXPERIENCE AND QUALIFICATIONS: Knowledge of SOPs & other Quality Documents Expertise in Course Design High level of expertise in Le@rn Learning Management System (Saba based LMS) Expertise in learning technologies i.e. Articulate; Adobe Connect, Brainshark, Storyline, etc. Expertise in MS PowerPoint, MS Excel, Survey Monkey Expertise in Sharepoint and Interwoven Excellent Communication Skills 3-5 years of experience working in the Pharmaceutical Industry 3-5 years of experience working in the Training Industry 3-5 years of experience designing and developing instructor led-courses and web-based training

courses 3-5 year of experience working in an LMS B.A/B.S Diploma Manager/Sr. Manager, Regulatory Affairs – Full Time Position (San Francisco Bay Area) PN94G DESCRIPTION: Responsible for implementing regulatory strategy and managing operational activities for assigned

projects.

2/2/2014 54

Provides input into global regulatory strategy. Manages planning and preparation of major regulatory submissions, e.g. INDs, NDAs/BLAs, annual

reports, orphan drug applications. Coordinates and prepares responses to health authority questions. Interacts verbally and in written fashion with regulatory agencies under the general direction of the

department director. Serves as regulatory representative on various subteams, e.g. study team. Interacts with consulting groups working on various regulatory projects. Periodically performs reviews/audits of internal systems to ensure ongoing compliance with SOPs

and regulations. Participates in multidisciplinary team audits. Maintains ongoing review of regulatory publications. Keeps necessary personnel apprised of changes in regulatory policies of practices for domestic and

international regulations. Performs regulatory intelligence searches for registration and other regulatory requirements as

applicable. Trains regulatory and clinical personnel on regulatory guidelines and internal procedures for

submission to regulatory agencies. Under the general direction of the department director oversees work assignment of Regulatory

Coordinator. EXPERIENCE AND QUALIFICATIONS: Excellent communication skills, both oral and written. In-depth knowledge of FDA regulations and ICH guidelines and general understanding of the

regulatory environment. Interpersonal skills and flexibility needed to work with, and in the confidence of, a diverse set of

team members from different disciplines. Ability to multitask and work under tight deadlines; excellent organizational skills. Proficiency with standard software programs (MS Word, Adobe Acrobat, etc.). Fluent in written and spoken English. BA/BS in Life Sciences or related field. 5 years minimum regulatory affairs experience in the pharmaceutical/biotechnology or medical

device industry with appropriate management experience. 7 years in the pharmaceutical/biotechnology or medical device industry to include experience in

R&D, clinical and/or quality. Experience preparing, managing and submitting regulatory submissions required. Experience with NDA/BLA submissions highly desirable. Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB DESCRIPTION: Provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates. Responsibilities: Manage the QA Document Control system. Assist in SOP writing and/or review. Assist in preparing and hosting Client audits Write/review/track CAPAs for audits. Conduct audits (internal systems and vendor) Provide QA/compliance advice to staff. Perform other related duties as assigned. EXPERIENCE AND QUALIFICATIONS:

2/2/2014 55

Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.

Working knowledge and understanding of drug development and global clinical regulatory environment.

Outstanding interpersonal, oral and written communication skills. Detail oriented. Available to travel 10% of the time. Bachelor's degree in scientific or related discipline, or equivalent work experience. Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA. Direct experience with internal/external clinical systems and process audits. Experience in QA audits of Clinical Investigators and Clinical Vendors. Experience in development of SOPs. Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook. Excellent

presentation skills. Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL DESCRIPTION: Reports to Sr. Director Clinical Operations; position initially has no direct reports but may within a

year Manage Phase 2A to 2/3 oncology program including CRO’s and vendors to ensure that the

study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines

Works closely and independently with the CMO and Medical Directors and represents clinical operations for this program

EXPERIENCE AND QUALIFICATIONS: Experience in Oncology required Must be hands on and used to a start-up environment Knowledge of GCP and ICH guidelines required Proficiency in the implementation, monitoring, and management of clinical trials Able to work collegially within a team and carry out duties/responsibilities with general instructions Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project Must be willing to travel occasionally (this is an in-house position so very little travel is required) Previous experience as with minimum title of SCRA Study start-up experience is required Global trial experience is desirable Demonstrated stellar track record in the oversight of alltrial operational aspects including: budgets,

timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.

Bachelor’s degree in a relevant scientific discipline or equivalent At least 4 years of relevant clinical experience in the pharmaceutical industry or equivalent (SCRA)

and minimum of 7 years for Clinical Program Manager title. Must have 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or

diagnostics company) environment Basic relocation provided IVD (Clinical) Project Manager – Contract (San Francisco Bay Area) RX108F DESCRIPTION: Coordinates set-up for companion diagnostic required for Phase 3 program. Works with assay laboratory, CRO, and internal client contacts. EXPERIENCE AND QUALIFICATIONS: Must have deep IVD development experience Must be hands on but strategic

2/2/2014 56

Must have minimum of 5 years experience working with IVD in either a Clinical Operations or Project Management capacity with minimums titles of Clinical Trial Manager or Project Manager in a Diagnostics company or a Pharma / Biotech company developing a companion IVD.

Higher level candidates preferred. Minimum of Bachelor Degree Sales – Contract (Massachusetts) 2801B73 DESCRIPTION: Email prospecting of existing company database, NIH grant databases, Tradeshow leads and lists

from Sales Engineers for possible leads Identifying cross-sell/up-sell opportunities Providing e-mail blasts and PDFs to leads who request more information. Entering all qualified leads into spreadsheet and report daily to manager Providing weekly reports to track metrics EXPERIENCE AND QUALIFICATIONS: Ability to work in a quota driven environment Be a proactive individual, as well as have solid communication, organizational, time-management,

and PC skills Confident and polished email prospecting skills Be a self-starter that is quickly motivated, effectively implements programs, recognizes

opportunities quickly Enjoys the challenge of obtaining new sales ********************************************************************************* Apply on company website Principal Process Engineer Hyde Engineering + Consulting - North Bay Area Posted 6 days ago Job description The principal process engineer is responsible for office and site based engineering design, commissioning and startup activities for cGMP Biopharmaceutical clients. Responsibilities

• Lead design, implementation, commissioning, qualification and operation of process and laboratory equipment to meet project goals.

• Support and lead Capital projects to implement process improvements and process equipment upgrades/changes.

• Actively use project management tools to independently manage medium/large-sized projects.

• Ensure a safe working environment by following safety rules and helping improve the safety culture.

• Lead troubleshooting efforts to resolve more difficult equipment and operational problems. • Provide engineering expertise and drive technical decisions as active member of area

process team. • Identify and drive improvement opportunities (procedural changes, upgrades, projects, etc.)

associated with equipment within the area. • Support manufacturing operations: Lead and support deviation investigations associated

with process equipment and operations, lead and support implementation of corrective actions and change controls for process improvements and enhancements.

• Perform deviation investigations Desired Skills and Experience

• BS degree or higher in chemical engineering • 10+ years experience in the Pharmaceutical industry • Ability to lead project teams to ensure successful project outcomes

2/2/2014 57

• Familiarity with process design and operations • Familiarity with process modelling and utility sizing calculations • Familiarity with engineering project management • Understanding of Fermentation, Cell Culture, Centrifugation, Chromotography, Tangential Filtration

Flow, CIP and SIP • Strong verbal and written communication skills • Ability to work independently and within project teams • Industry experience related to cGMP drug manufacturing, validation, and chemical process design • Strong computer knowledge including Microsoft Office products Are you looking for a meaningful career that makes a difference in the world? Then consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers are able to effectively and safely produce their life enhancing and often life saving medicines. At Hyde E+C we want to attract the industries best and brightest to help us achieve our vision to be the premier Biopharma Process Engineering, Validation and Regulatory Compliance Solution Provider in all Markets we service. To do so, we offer competitive compensation, excellent benefits and a strong commitment to work/life balance. At Hyde E+ C you will find these values reflected in our company:

• Family Happiness • Integrity • Friendship • Wisdom • Adventure Since 1993, Hyde Engineering + Consulting has worked as an integral part of project teams for clients and equipment vendors resulting in the successful construction, commissioning and validation of facilities and equipment . We provide high value engineering, compliance, qualification and automation solutions to the Biopharmaceutical and Biocommodity industries. Our knowledge and experience as well as our in-depth understanding of the regulatory FDA/EMEA risk based management approach, provides added value for our clients across the globe. Our offices are located: Domestically - California, Colorado, North Carolina, Pennsylvania, and Massachusetts; Internationally - Ireland, India, Singapore and China ********************************************************************************* Apply on company website Process Engineer Complete Genomics Inc. - San Francisco Bay Area Posted 5 days ago Job description We are looking for a motivated process engineer to join the Complete Genomics reagents team. The successful candidate will support the Reagent Manufacturing, Filling and Packaging departments, and contribute to the commercialization of consumables for our next generation DNA sequencing factories. Responsibilities:

• Lead process scale-up, technology transfer, and equipment/process validation activities, as related to the Formulation, Filling, Labeling, and Packaging of CGI’s consumable Reagents. Will help to develop and qualify robust, high quality, and cost effective processes for manufacturing of these products.

• Drive implementation through manufacturing, including setting up infrastructure, production documentation, and training on new processes and equipment.

• Ensure manufacturability of operations as it pertains to the utilization of staffing, facility (layout, etc.), materials, and equipment.

• Work with development and hardware engineers to establish equipment/instrumentation requirements and specifications. Interfaces with vendors on procurement, installation, maintenance, etc.

• Responsible for ongoing technical support of sustaining operations, including troubleshooting of equipment and process problems.

• Generate various documentation such as process flow diagrams, operating procedures, work instructions, equipment SOP’s, validation plans, reports and protocols.

2/2/2014 58

• Conform to requirements for Design Control. Perform design and process risk assessments, such as pFMEA. Conduct design reviews.

• Apply working knowledge of Lean/Six Sigma principles in manufacturing, utilizing various tools (VSM, 5S, Kaizen, Visual Controls, etc.) to drive Continuous Improvement efforts. Develop metrics and controls to drive manufacturing improvements in the areas of cost, quality, yield, safety, and TAT.

Desired Skills and Experience • Degree in Bioengineering, Chemical Engineering, Industrial Engineering or related field. • 6+ years of industrial experience in the commercialization, scale up, transfer, and validation of

molecular biology based consumables. Familiarity with the handling and processing of oligo and enzyme based reagents.

• Strong practical experience in the filling, labeling and packaging of consumable products, as well as familiarity working in controlled manufacturing environments and under aseptic conditions.

• Background in automation, robotics, filling, packaging and labeling equipment a must. • Expertise in the optimization of manufacturing processes through the use of Lean/Six Sigma tools

and principles, statistics and data analysis methodologies. Green or black belt highly desirable, with strong understanding of Operational Excellence concepts.

• Experienced with the systems used in production environments, such as the laboratory information management systems (LIMS) and business systems (Oracle ERP).

• Strong project management and organizational skills, with great attention to detail. Ability to handle multiple projects at once of varying scope and complexity.

• Creative thinker, with strong analytical and problem solving skills. • Demonstrated strength working with cross-functional partners in a rapidly changing and

challenging production environment. • Strong working knowledge of Design Control requirements and Quality Systems. • Experience working in an ISO 13485 or cGMP environment a plus. Complete Genomics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Complete Genomics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Complete Genomics and will be processed accordingly without fee. Complete Genomics has the sole discretion to determine with whom we will enter into a contract. If you wish to work with Complete Genomics, please contact the Human Resources department at careers@completegenomics.com. Complete Genomics is proud to be an equal opportunity employer ***************************************************************************** Apply on company website Engineer I - Late Stage Cell Culture Development Genentech - US -CA-South San Francisco Posted 5 days ago Job description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

2/2/2014 59

The Position Job Title: E. coli Fermentation Process Development Engineer I Department: Late Stage Cell Culture, BioProcess Development Position: Engineer I, E2 Location: South San Francisco, CA Job Description The candidate will contribute to the development and characterization of microbial fermentation processes for the production of recombinant proteins of therapeutic interest. Responsibilities will include participation in experimental design and execution of fermentation studies, analyses of data generated from in-process samples and culture trends and application of results to future experiments. Experimental data will ultimately be summarized in technical documents and reports. The candidate will also contribute to the identification and evaluation of new technologies related to protein expression and fermentation process development. The candidate will also support fermentation technology transfers across Roche/Genentech’s drug substance manufacturing facilities and to external contract manufacturing facilities. In addition, the candidate may have the opportunity to contribute to mammalian cell culture projects. This position will require a significant amount laboratory bench work and effective internal and external departmental collaborations to achieve desired results. Flexible working hours may also be required. Who You Are The candidate should have a BS or MS in chemical or biochemical engineering or related field with 2-4 years of related experience. Experience with bacterial fermentation, quantitative analysis and assay development is highly desirable. Strong analytical skills in addition to excellent verbal and written communication abilities are required. The candidate should be highly motivated and organized with the ability to work independently and in a team environment. The next step is yours. To apply today, click on the "Apply online" button below. Genentech is an Equal Opportunity Employer. **************************************************************************** Apply on company website Associate Process Engineer Experis - Emeryville, California Posted 1 day ago Job description Associate Process Engineer Duties This position will be responsible for providing technical support for routine manufacturing and development activities within the Dx Tech Ops Group. Major Accountabilities: Understand "GXP" requirements for operations which support Dx manufacturing. Write and train other associates on operational procedures or analytical methods. Support the design, implementation, commissioning, qualification and operation of process and laboratory equipment to meet project goals. Support and lead Capital projects to implement process improvements and process equipment upgrades/changes. Understand "GXP" requirements for operations which support Dx manufacturing. Write and train other associates on operational procedures or analytical methods. Understand requirements of equipment lifecycle for manufacturing and laboratory equipment. Support all

2/2/2014 60

equipment lifecycle activities (implementation through decommissioning) for new and existing "GXP" equipment. Support manufacturing operations: Lead and support deviation investigations associated with process equipment and operations, lead and support implementation of corrective actions and change controls for process improvements and enhancements, troubleshooting equipment failures, evaluation and implementation of preventative maintenance and calibration activities, design and development of cleaning methods for process equipment, Skills Key Performance Indicators: · Timeliness and accuracy of project completion according to plan goals. · Accurate data review, technical insight demonstrated by creative application of scientific principles. · Metrics for equipment uptime, process improvements. · Ability to train others on new procedures. · B.S. in chemical or mechanical engineering · 0-3 years relevant industry experience · English · Other languages desirable Ability to work independently and within project teams. Must be motivated and able to work under tight deadlines. Ability to prioritize, multi-task, and flexibility. Strong problem solving and analytical skills. Strong written and interpersonal communication skills. Proven success and demonstrated leadership ability within a previous academic and/or industrial setting, an added plus. Keywords Education · B.S. in chemical or mechanical engineering Experis is an Equal Opportunity Employer (EOE/AA) ************************************************************************* http://www.linkedin.com/jobs2/view/10434477?trk=job_view_browse_map Pharmaceutical Plant Engineer Delta Project Management - San Francisco Bay Area Posted 2 days ago Job description Delta Project Management (DPM) is looking for an experienced Plant Engineer to join our growing staff of consultants. This positiion will report to client engineering managers responsible for the operation, maintenance and calibration of commercial scale pharmaceutical and biopharmaceutical manfuracturing facilities.

2/2/2014 61

Ideal candidates have a strong grounding in GMPs and experience working as an engineering supporting commercial or clinical scale Biotech facilities. Familiarity with reliability programs, preventive maintenance, change control, DR and CAPA is a plus. Candidate will be responsbile for leading initiatives on behalf of the plant engineering department to ensure preventive maintenance, spare parts and reliability programs are meeting department expetations. Will work with clean utilities such as Water for Injection, Clean Steam, classified HVAC areas, process gases, etc. Potential to support the implementation of capital projects as a client side engineering representative. Desired Skills and Experience

• BS/MS in mechanical or chemical engineering, or related field/experience • Minimum of 5 years experience in GMP engineering in the pharma/biotech industry is required. • Working knowledge of multiple types of manufacturing environments including fill/finish, solid oral

dosage, spray dry, etc. is a plus. • Ability to work independently on projects with applicable client stakeholders in Validation, Quality

Assurance, Manufacturing and Maintenance personnel. • Basic understanding of change control is a plus • Experience supporting discreapancy reporting and investigations • Experience supporting Corrective Action and Preventive Action (CAPA) initiatives • Experience with WFI, Clean Steam, HVAC and process gases as applied to GMP manufacturing. Delta Project Management (DPM) is a San Francisco Bay Area-based provider of staff and consulting services for the biopharmaceutical, medical device, and pharmaceutical industries. Delta PM specializes in Capital Project Management, Commissioning and Qualification, Validation, Engineering Support, and Regulatory Compliance. DPM is also a recognized world-wide leader in the highly specialized area of diabetes marketing strategy. Our clients range from Fortune 500 biotech/pharmaceutical companies, to start-ups that seek assistance in bringing a product to market. ********************************************************************************** Apply on company website Senior Pharmaceutical Engineer Gilead Sciences - Foster City, California Posted 2 days ago Job description Join a dynamic technical team overseeing commercial manufacturing processes to ensure an uninterrupted supply chain. Extensive experience in technology transfer and process validation of pharmaceutical oral solid dosage forms. Technical expertise in all processing areas to include granulation, compression, and coating. Demonstrated leadership on technical projects with the ability to work on a cross-functional team.

• Contributes to and may lead complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.

• Works collaboratively with multiple functional areas to meet complex project deliverables. • Contributes to and may lead technical investigations and assessment of deviations. • Examines inter-departmental working issues, primarily from interdepartmental perspective. • With minimal guidance, determines the functions most critical to departmental success and

supports priorities accordingly. • Oversees and contributes to the completion of all technical and operational activities related to

maintaining commercial product supplies through management of internal and external resources. • Responsible for defining, planning, and implementing activities on one or more complex projects

related to scale-up, validation, and technology transfer between sites to ensure production schedules are met.

• Leads activities at manufacturing sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for limited-scope projects.

• Defines requirements for, and reviews master batch records. • Serves as the technical lead and supports the specification, installation, utilization, qualification,

and improvement of equipment used for solid dose and liquid products.

2/2/2014 62

• Executes equipment/process qualification (IQ/OQ/PQ) and validation (PV); writes and may review qualification/validation/technical reports. Prepares documents for Regulatory filings, and reviews filings, including sections from other disciplines.

• Designs specifications and resolves technical issues with material suppliers. Desired Skills and Experience

• Strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).

• Excellent verbal, written, and interpersonal communication skills are required. • Strong computer, organizational, and project management skills required. • 7+ years of relevant experience and a BS or BA. OR 5+ years of relevant experience and a MS. Gilead Sciences was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. ********************************************************************************* Apply on company website Scientist - Medicinal Chemistry Amgen - Thousand Oaks, CA Posted 2 days ago Job description Part of a Medicinal Chemistry group, with responsibilities including (but not limited to) conducting laboratory experiments; designing and implementing scientific research; planning detailed procedures for defined projects including timelines, milestones, methodological approaches, expected results and necessary resources; reviewing, analyzing, and interpreting scientific data and results; providing regular updates, documentation, and/or communication on project results; collaborating with other scientists and keeping current with field of expertise, including literature and technology development. Additional responsibilities may include advising supervisors and colleagues in areas of expertise; participating in national and international scientific meetings; providing scientific results that support the generation of publications, patents, or regulatory submissions and supervising research associates and laboratory assistants. Basic Qualifications Doctorate degree (or pending completion in 2014) OR Master’s degree & 5 years of scientific experience OR Bachelor’s degree & 7 years of scientific experience Preferred Qualifications • Chemistry degree specializing in organic synthesis • Proven track record of academic accomplishments (i.e., peer-reviewed publications and/or patents) • Demonstration of good lab practices, with particular attention to safety • Clear understanding of structural determination using NMR and Mass Spectral techniques as well as knowledge of related purification methods • Understanding of biological and pharmaceutical principles and a working knowledge of the use of structure-based or other computer-aided drug design tools

2/2/2014 63

• Knowledge of the application of parallel synthesis techniques to medicinal chemistry a plus • Excellent communication skills (both written and oral) Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology, and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. ******************************************************************************** http://www.linkedin.com/jobs2/view/10434525?trk=eml-anet_dig-b_premjb-ttl-cn Peptide Chemist AnaSpec - Fremont, CA Posted 2 days ago Job description RESPONSIBILITIES

• Synthesize peptides both in solution phase and on solid phase • Synthesize peptides on automation mode and manual mode • Synthesize peptides in multi-gram or kilo production scale • Synthesize protected amino acid derivatives, and resin modification • Synthesize dye conjugated amino acids • Perform different peptide conjugation, including dye-labeled, FRET, and others • Design peptide production strategies, and design of experiment (DOE) • Perform peptide or other molecule analysis using MALDI-MS, LC-MS, HPLC, TLC, -UV-Vis, and NMR • Perform peptide purification using Prep-HPLC,recrystallization, and others • Perform peptide production process development and improvement • Perform methodology studies (R&D) on peptide synthesis and peptide purification • Be able to work independently Desired Skills and Experience REQUIREMENTS

• MS and/or PhD degree or higher in chemistry.. • Strong Organic background, perform multi-step synthesis. • Strong peptide synthesis using ssps and solution phase method. • Writing technical SOPs and technical reports • Experience in peptide modification and peptidomimetic • Five year peptide production (synthesis, purification, and analysis) experience • More than five year working experience in industry or biotech environment • Experience in instrumentation (analytical and synthesis) • Good oral and written communication skills. • Must be organized and detail oriented. • Experience working in a global atmosphere is a plus. • Proficient in computer skills (MS Office, data analysis, ChemDraw, others). AnaSpec, Inc. is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, life insurance, short-term & long-term disability, 401(k), and other benefits! Established in 1993, AnaSpec, Inc. is a leading provider of integrated proteomics and genomics solutions™ for worldwide life science research. As a subsidiary of Eurogentec, AnaSpec offers expertise in peptides,

2/2/2014 64

detection reagents, antibodies, assay kits, oligonucleotides, and qPCRs. AnaSpec carries a broad product line of biochemicals and reagents for basic research, high-throughput screening and drug discovery. The scientific team at AnaSpec is staffed by experts in the fields of peptide technology, fluorescence technology, antibodies, and combinatorial chemistry. Our expertise in these complementary fields translates into both premium quality products and cutting-edge innovation. ******************************************************************************** http://www.biophaseinc.com/viewjob.php?jc=j_sci&rec=3258 QC Technician BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a QC Technician to work for a leading Bay Area biotechnology company. QC Technician We are recruiting for a Quality Control Technician to work with our medical diagnostic client located in Fremont, CA. This is a temporary position with possibility of conversion to hire. Responsibilities:

• Conduct inspections and tests following quality control testing procedures, review device history records, provide disposition status of inspected/tested parts and provide support for quality control development and validation activities.

• Perform final QC testing utilizing custom built test system and Flow Cytometer. • Perform in process QC testing (pH, Osmolarity, Contact angle, Density, volumetric). • Collects, analyzes, interprets data and completes appropriate record keeping for all tests. • Sample management – Collection & processing of reagents used in the manufacturing. This

includes sending sample to outside lab and coordinating with lab for timely completion of tests. • Visual inspection of subassemblies per documented inspection procedure. • Participate in the development and validation of inspection and QC test methods (incoming, in-

process & release), test methods validation activities, documentation and reports. • Train manufacturing personnel on new in-process QC methods when applicable • Accurately document the results of the inspections and testing, document QC results, tracking

database and provide feed-back. • Review device history records for compliance to established procedures and Good Documentation

Practice. • Initiate Non Conformance Reports as necessary and participate in complaints resolution. • Prepare quality control reports as necessary. • Assist in the drafting and revision of operating procedures and data tracking forms related to

inspection. Requirements:

• High School Diploma/Associate degree or equivalent experience in a Life Science Curriculum (Biochemistry, Chemistry, Materials Science, or Medical Devices).

• Minimum of 2 year experience in a hands-on, wet bench manufacturing support related position in the chemical or biotech industry.

• Flexibility to work various shifts or weekends as needed. • Proficient hands on experience with standard biotech laboratory and work practices (pipetting,

balances, pH meters, vortex mixer etc. • Working experience under cGMP. • Experience or ability to work in a BSL2 laboratory area, cleanroom, and with handling of human

patient fluid samples. • Hands on experience with microscopy / microscope observations, measuring tools and standard

biotech laboratory equipment (e.g. pipetting) and practices. • Excellent English verbal and written communication skills. • Proficiency with MS Word, Excel and PowerPoint. • Maintain extreme attention to detail and organization in all aspects of work. • Learn quickly and apply new skills, procedures and approaches; and handle multiple competing

priorities in a fast-paced work environment. • Effectively document procedures, processes, and results. • Good working knowledge of basic data analysis. • Proven ability to work collaboratively in a team-based environment.

2/2/2014 65

• Preferred skills include aseptic technique, and blood handling. • Location: San Francisco / Bay Area • Type: Contract To Hire • Rate: $ • Job ID: SF-454

************************************************************************************** Send an updated resume to brannon@alliedsearchpartners.com for review. Full time/permanent CLS (Solid Tissue) opening in southern CA. Must have a CA CLS license and IHC experience. Brannon OwensDirector, Staffing at Allied Search Partners

http://www.alliedsearchpartners.com/careers.php ***************************************************************************** *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ******************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/ Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2013 report authored by CHI, PWC and BayBio at http://www.californiabiomedreport.com/ ******************************************************* Writing Resumes UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________

2/2/2014 66

NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ______________________________________________________________ Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions: 1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position.

2/2/2014 67

3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what you want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume

2/2/2014 68

to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at caldwell@biotechink.com, phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. ___________________________________________________ “Writing Your Career Change Resume- 5 Tips,” Job-Hunt.org…your objective source of job search resources website; this might be helpful for those of you leaving a bench science position to another function inside a life science company. http://www.job-hunt.org/career-change/resume-for-career-change.shtml I googled several questions about writing a resume and was astounded that the different sites with free advice, templates, etc. Of course, some service providers were also listed. I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/ Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com • PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma • http://realendpoints.com/blog/ on pricing and reimbursement • Luke Timmerman’s blog on Xconomy. *********************************************************************

2/2/2014 69

Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites There’s a new biotech job site on the BIO website entitled Bio Jobs: The Talent Hub for Biotech at http://jobs.bio.org. You can search for open positions via various parameters. Review my weekly listings for individual recruiters and review their websites where they post jobs. Be sure to join the Bio2Device Group and their Linked In Groups where jobs are posted. There are specialized linked in groups that list jobs in the area of interest to its members. I’m a member of separate linked in groups in marketing and marketing research where I gather jobs for my weekly postings. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at wd_darshana@hotmail.com. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://www.the-scientist.com/?articles.view/articleNo/32918/title/Life-Sciences-Salary-Survey-2012/

2/2/2014 70

Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/contents/view_salary-survey/2012-06-19/2012---thirteenth-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/more-work-fewer-perks-medtech-employees. You can also find salaries for other functions at the same location. MM&M reports salaries in the September issue each year. See 2012 results at http://media.mmm-online.com/documents/40/2012_survey_9911.pdf ************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com/blog along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at audreyerbes@aol.com if they wish to receive these mailings directly. *************************************************************************