5/24/2015 1

Jobs That Crossed My Desk Through May 24, 2015 Complimentary Service of Audreysnetwork.com

May 24, 2015

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. Next BioSpace Career Fair in Bay Area scheduled for Oct. 28, 2015. See details at http://www.biospace.com/jobs/career-fair/

************************************************************************* Please visit our website for full job descriptions and requirements for each role. And, feel free to pass this along as you see fit. http://bulletproofdocs.com/opportunities.php

Bulletproof Documentation, Inc. specializes in high-quality consulting services for the pharmaceutical and medical device industries. With over 20 years of experience, Bulletproof can fulfill your needs on any project, large or small. Whether the deliverable is technical writing, project management, instructional design, or customized projects — it’s not showy, just clean, tight, and right. It's bulletproof. We are seeking project managers for immediate contract opportunities.

Senior project managers: Quality workstreams (3+ month contract, Asia)

Project managers: CMC technical development teams (8+ month contract, SF Bay Area)

We are seeking technical writers for several immediate contract opportunities.

Senior technical writers: Methods and QC Compliance (7+ month contract, San Diego area)

Technical writers: CMC technical reports (6+ month contract, SF Bay Area)

Technical writers: Biologics drug substance manufacturing (3+ month contract, Asia)

Associate technical writers: API pilot plant manufacturing (6+ month contract, Cody, Wyoming)

Documentation specialist: Diagnostics manuals and labeling (12+ month contract, SF Bay Area)

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

5/24/2015 2

TO APPLY:

https://www.gilead.apply2jobs.com/ProfExt/index.cfm?fuseaction=mExternal.showJob&RID=20587&CurrentP

age=1

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. Position: Manager, Vendor Relationship Management

Gilead Sciences is currently seeking a Manager, Vendor Relationship Management in the Clinical Contracts & Finance department. The successful candidate will have broad clinical operations and direct vendor or alliance management experience in addition to a foundation in clinical outsourcing and contracts management. CRO experience is preferred.

Responsible for all aspects of clinical operations and vendor relationship management. Works collaboratively with internal business partners to deliver greater operational performance and quality from vendors while maintaining a strategic focus and strong relationships.

Responsible for developing, managing or supporting the clinical operations vendor governance processes at the management or executive levels.

Responsible for Key Performance Indicators oversight through review of vendor metrics, trending analysis, and reporting to business partners.

Leads or supports program or portfolio level issue resolution, monitor issues, assess risk levels and trending. Supports successful escalation pathways.

Leads or supports the establishment and/or evaluation of vendor business processes, innovation or process improvement opportunities.

5/24/2015 3

Ensure consistency or adherence in complex vendor management specific policies and procedures.

Demonstrates understanding of corporate and department goals by partnering with business partners and vendors to achieve such business objectives as they relate to vendor management.

Communicates decisions, issues, risks and new processes to business partners, including Senior Management.

Leads vendor life cycle management process as it relates to relationship management. e.g. provides input about the vendors included in RFP positions, ensures performance metrics embedded in Quality Agreements.

Ensures vendor processes are contributing to corporate success in a timely and cost effective manner

Is highly collaborative and is sought out for advice by others within the Company to help make better decisions and resolve problems.

Essential Duties and Job Functions:

Responsible for developing departmental & cross-functional vendor management tools

Assists with organizational strategy development

Provides organizational training to relevant internal stakeholders and teams

Manages complex processes across functions, interacts effectively with the clinical teams and related departments

Serves as a liaison between the department and other department managers

Examines functional issues from a broader organization perspective

Provides input to the Vendor selection process in conjunction with business partners

Prepares, presents, leads meetings

Demonstrates excellent verbal, written, presentation and communication skills

Demonstrates a broad knowledge of Biometrics and Clinical Operations across functions

Performs responsibilities without appreciable direction.

May manage staff grade 28 and below.

Travel may be required

Demonstrates all the skills of a Vendor Relationship Management Manager, e.g. strong interpersonal “soft” skills, ability to lead through influence

5/24/2015 4

Knowledge, Experience and Skills:

8 years of experience with a BA in a relevant discipline. 6 years of experience with a MS in a relevant discipline. Relevant experience typically includes contract negotiation, clinical finance, vendor management and/or alliance

management. MBA preferred Relevant experience typically includes biometrics operations, clinical operations, clinical outsourcing, contract

negotiation and/or clinical finance. CRO experience is a strong plus.

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

Jobs That Crossed My Desk Through May 10, 2015 ********************************************************************** Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com tel: 925-577-8135 MANUFACTURING, OPERATIONS & R&D ENGINEERING Director of Operations

10+ years of experience in medical device manufacturing/operations, ideally in a small company environment. Experience with silicone/plastic devices is a plus.

Demonstrated experience establishing and executing budgets and operating plans. Demonstrated ability to manage and prioritize multiple projects with excellent project planning and

execution skills. Knowledge of Quality Control, Manufacturing Engineering, Purchasing, Planning, Inventory Control,

Document Control, Shipping and Receiving, Facilities/Maintenance, FDA GMP and ISO 13485 regulations.

Have written, implemented and managed manufacturing procedures and specifications. Have demonstrated abilities managing external vendors. Be a self-starter, very well organized with strong attention to detail. Have a personality that is adaptable and a good fit with a small start-up company.

____________________________________________________________________ Sr. Manufacturing Engineer

BS degree, advanced degree is a plus 5+ years of relevant manufacturing experience in medical device industry

Industrial Engineering degree is a plus Solid understanding of Lean Manufacturing principles. Possess excellent communication skills – both written and oral.

____________________________________________________________________

Mechanical Laser Process Engineer BS degree in relevant discipline, advanced degree is preferred 3 - 5+ years of relevant engineering experience in medical device industry Laser experience and a mechatronics background SolidWorks background

____________________________________________________________________

Manager, Equipment Engineering BS Engineering degree required, advanced degree is a plus

8 – 10+ years of relevant engineering experience Six sigma, process excellence experience preferred Strong people management skills required Broad-based knowledge relating to software and control systems required

Strong analytical problem-solving and interpersonal skills, leadership skills, technology management and

customer-focused decision making ____________________________________________________________________

5/24/2015 5

Sr. Process Development Engineer (thermo-mechanical processing)

Bachelor's degree in Engineering 5+ years experience in process development engineering Experienced in incorporating radiopaque markers Ability to communicate clearly and efficiently in a highly technical environment. Capacity to work independently, with minimal supervision. Experience working in a regulated environment is a strong plus Experience with gage R&R, DOE set-up and analysis. Experience with Solidworks.

SALES, MARKETING, BUSINESS DEVELOPMENT & CUSTOMER/PRODUCT SUPPORT Director, Digital Marketing

BS/BA or equivalent in Business or Marketing, MBA preferred 10+ years marketing experience, including at least 6 years in a hands-on digital marketing role

that included acquisition, conversion and retention strategies across all of the key digital marketing vehicles (paid and organic search, affiliates, display advertising, re-marketing, CRM/email)

Familiarity with implementing digital programs across different devices (mobile and tablet) Proven success building a team and training at least one direct report Demonstrated ability to work well with agencies and strategic partners Highly-analytical, metrics-driven leader with a track record of success in providing analysis,

strategic direction, and specific business recommendations to senior management on critical decisions

Solid knowledge of website analytics tools (i.e. Google Analytics) and ability to use MS Word, Excel and PowerPoint effectively

Demonstrated ability to multi-task in a fast-paced, rapidly changing environment Must have the ability to travel up to 20%, including occasional international travel Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR),

ISO13485, the Canadian Medical Device Regulations, and all other international regulatory

requirements Experience in beauty or aesthetics is a plus

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

Our startups and affiliates are hiring. See selected openings below. We maintain current job listings

at http://jobs.qb3.org/?mc_cid=108d44da01&mc_eid=[UNIQID]. If you would like to post an opening on our website, please contact us with your name, email address, and company name. We will forward this to VentureLoop, the third party who manages

our job listings. They will contact you and set you up with access to a free account so you can manage your own posting details.

Caribou Biosciences: four positions. Applicants should e-mail jobs@cariboubio.com. Caribou Biosciences – Scientist, Functional Genomics

Caribou Biosciences is a cellular and genome engineering company focused on the commercial development of technology and products based on enzymes from prokaryotic CRISPR immune systems. We are located in Berkeley, California.

Job Description and Specific Responsibilities We are seeking a Scientist to join our Functional Genomics group to further develop our CRISPR-Cas based functional genetic screening capabilities. The successful applicant will interact closely with Scientists and RAs to design, execute and analyze experiments based on our CRISPR-Cas

platform. The responsibilities for this position include designing and constructing libraries for functional genetic screens, high-throughput screening and data analysis. The candidate must be well organized and have strong written and verbal communication skills. Caribou Biosciences is a dynamic start-up company, and the successful applicant will work in a positive, fast-paced

5/24/2015 6

multidisciplinary environment where s/he will make significant and creative contributions. Qualifications and Experience Requirements: • PhD in Biochemistry, Bioengineering, Bioinformatics, Cell Biology, Genetics, or Molecular Biology OR MS with 4 + years of experience • Direct experience with high-throughput forward genetic screens (shRNA-based or CRISPR-Cas based) • Firsthand experience with preparation of Illumina sequencing libraries • Proficiency in statistical analysis of NGS data Additional positives: • Deep understanding of the molecular mechanisms of DNA repair pathways

• Mammalian tissue culture and virus production expertise • Experience working in a biotech or pharmaceutical company • Hands-on experience with laboratory automation systems

Caribou Biosciences – Molecular Biology Research Assistant Caribou Biosciences is a cellular and genome engineering company focused on the commercial

development of technology and products based on enzymes from prokaryotic CRISPR immune systems. We are located in Berkeley, California. Job Description and Specific Responsibilities

We are seeking a Research Assistant in our Technology Development group. The ideal candidate will interact closely with Scientists and other RAs to develop standard protocols for novel cell and genome engineering procedures. The responsibilities for this position include preparing Illumina sequencing libraries, automated electrophoresis, qPCR, and RNA synthesis. Previous experience

working with high-throughput/laboratory automation systems would be highly preferred. The candidate must be well organized and have strong written and verbal communication skills. Caribou Bio is a dynamic start-up company, and the successful candidate must have the ability and desire to work within a fast-paced environment.

Qualifications and Experience Requirements:

• B.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology • Minimum of 3-5 years experience working in a biotech or pharmaceutical company • Direct, hands-on experience with preparation of Illumina sequencing libraries • Experience with qPCR experiments

• Experience with conventional molecular biology techniques Additional positives: • Experience with mammalian cell culture

• RNA synthesis and purification and RNA library preparation experience preferred • Hands-on experience with laboratory automation systems • M.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology Caribou Biosciences – Cell Engineering Research Assistant

Caribou Biosciences is a cellular and genome engineering company focused on the commercial development of technology and products based on enzymes from prokaryotic CRISPR immune systems. We are located in Berkeley, California.

5/24/2015 7

Job Description and Specific Responsibilities We are seeking a Research Assistant in our Cell Engineering group. The ideal candidate will interact closely with Scientists and other RAs to support cell culture and cell engineering activities. The primary responsibilities for this position include culture, maintenance and characterization of human and mouse primary cells and cell lines, preparation of materials for transfection (e.g. plasmids, protein, RNA, RNP), cell transfection using a range of techniques, analysis of experiments using flow cytometry and FACS analysis. A candidate with an experimental background in ESC, iPSC, HSC or other stem cell systems would be strongly preferred The candidate must be well organized and have strong written and verbal communication skills. Caribou Bio is a dynamic start-up company, and the successful candidate must have the ability and desire to work within a fast-paced environment. Qualifications and Experience

Requirements: • B.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology • Minimum of 4-5 years experience working in a biotech or pharmaceutical company • Direct, hands-on experience with culturing, characterizing and transfection of a range of

mammalian primary cell types. • Experience with FACS and flow cytometry based characterization and assays. • Working knowledge of basic molecular biology.

Additional positives: • Experience with flow cytometry-based activity assays • Background including hands-on work with laboratory automation systems • M.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology

Caribou Biosciences – Cell Engineering Research Assistant #2 We are seeking a Research Assistant in our Cell Engineering group. The ideal candidate will interact

closely with Scientists and other RAs to support cell culture and cell engineering activities. The responsibilities for this position include culture and maintenance of human and mouse primary cells and cell lines, viral vector development, packaging and production, cell transfection using a range of techniques, analysis of experiments using FACS and flow cytometry. The candidate must be well

organized and have strong written and verbal communication skills. Caribou Bio is a dynamic start-up company, and the successful candidate must have the ability and desire to work within a fast-paced environment.

Qualifications and Experience We favor candidates with the following credentials:

• B.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology • Minimum of 4-5 years experience working in a biotech or pharmaceutical company • Experience with viral vector development, production, validation and quality assessment • Direct, hands-on experience with mammalian primary cell and cell line culture maintenance,

cell transfection and flow cytometry. • Experience with high throughput flow-cytometry based assays and analysis. Pluses:

• Experience with flow cytometry-based activity assays • Background including hands-on work with laboratory automation systems • M.Sc. or equivalent in Biochemistry, Bioengineering, Cell Biology, Genetics or Molecular Biology

5/24/2015 8

____________________________________________________________________ Job Posting: Business Development Summer Internship at Cairn Biosciences Cairn Biosciences is a San Francisco-based startup developing the next generation of live cell tools to enable and accelerate the development of new classes of therapeutic for serious disease. By measuring the dynamic behavior of cellular machinery, our live cell high-content screening (LC-HCS) platform pinpoints and measures the diverse aspects of cellular physiology that are perturbed by candidate therapeutics and disease pathologies, enabling faster discovery of better therapeutics at reduced cost. We are seeking a pro-active, analytical and goal-oriented Business Development Intern with experience or a strong interest in commercializing tools, technologies and/or services for drug discovery to join our team for the summer. Cairn Biosciences fosters a dynamic start-up environment where self-driven, enthusiastic employees thrive. The successful candidate will bring

their entrepreneurial, collaborative and highly organized mindset to bear on acquiring and analyzing business intelligence from diverse sources and using it to develop a detailed commercialization plan for our technology platform.

This position is for an 8-12 week paid summer internship starting in June 2015, however we are enthusiastic to commence the project earlier via a part time experiential project subject to candidate availability.

Key responsibilities • Take a leading role in developing and preparing commercialization plan for a National Science Foundation grant funded technology

• Drive comprehensive top-down and bottom-up analysis of the market opportunity for our technology by researching industry databases and market reports and surveying and interviewing prospective customers • Develop a comprehensive analysis of current and future competitors of our technology • Evaluate barriers to market entry for our technology

• Assist in developing a comprehensive finance model for our technology (including pricing strategy and revenue model) • Develop internal systems and recommendations for ongoing market research and competitive intelligence monitoring and analysis

Required qualifications and experience • MBA graduate or current student or equivalent business training experience through study or

professional experience • Demonstrated ability to structure and conduct analysis of diverse data sources to generate actionable business strategy • Fluency with Excel/spreadsheets for budgeting, forecasting and business model development

• Strong quantitative and analytical skills • Exceptional interpersonal, written and verbal communication skills • Demonstrated ability to prepare and deliver compelling presentations • Excellent attention to detail with outstanding organizational and documentation skills

The following skills and experience are also highly desirable: • Drug discovery or life science tools industry experience; cell biology, microscopy or high throughput screening expertise is especially desirable

• Business development, consulting, sales and marketing, finance, venture capital and/or early stage startup work experience • Experience in developing marketing materials, website design, social media marketing strategy and/or pitch deck preparation

5/24/2015 9

• Project management experience • Familiarity with Lean LaunchPad business model generation philosophy Cairn Biosciences is an Equal Opportunity Employer. As an early-stage startup company we cannot pay to relocate employees nor sponsor work authorizations or visas. Note to employment agencies: Please do not forward agency resumes; Cairn Biosciences will not be responsible for any fees related to resumes that are unsolicited. Please submit your application materials to careers@cairnbio.com ____________________________________________________________________

Research Scientist, Nano Precision Medical Company description: Nano Precision Medical is a start-up medical device company located in Emeryville, CA. We are developing

a small, implantable device to improve treatment for people suffering from chronic diseases by providing sustained medication levels over several months without the need for injections. Job description:

We are seeking a Research Scientist to help with planning, logistics, analysis, and communication of ongoing studies. Candidate should have the ability to sift through, interpret, summarize, and present conclusions from complex data sets so that others on the team can quickly understand the pertinent information in order to optimize processes. Furthermore, the candidate should be able to track logistics for

numerous parallel experiments both in house and through contractors and ensure that the data that is gathered is well organized and high quality. Familiarity with analytical chemistry techniques is desirable, but not imperative.

Minimum Qualifications: • PhD degree in Chemistry, Chemical Engineering, Bioengineering, Material Science, or related field. • Must be functional with minimal oversight. • Excellent attention to detail. • Good lab technique and practices.

• Excellent communication and documentation skills. • A desire to solve difficult, loosely defined or open ended challenges. • Experience with spreadsheets, databases, and/or programming for data analysis. • Experience organizing logistics of complex groups/processes.

Desired Qualifications: • Analytical chemistry background with chromatography and mass spec techniques. • Experience with analysis of error propagation.

• Experience managing projects. Logistics: - Full time

Please send your resume to careers@nanoprecisionmedical.com with "Research Scientist" in the subject line. This position is to be filled ASAP. No submissions will be accepted after 6/1/2015. ***********************************************************************

https://jobs.smartbrief.com/action/listing?listingid=5B2EC8CF-DF29-4158-A854-8E8AE945679D&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary

Date Posted: 5/5/15 Location: Santa Clara, CA

5/24/2015 10

Salary Range: Open Years Experience: 3 Sr Statistician I (US/TB/00/0028/SL) - 14000007LV Abbott Job Description Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people. Visit Abbott at http://abbott.com/index.htm and connect with us on Twitter at @AbbottNews. Follow us on LinkedIn

Primary Job Function

PROTOCOLS INPUT, RANDOMIZATION SCHEDULE, AND DATABASE ACTIVITES - Works with project team to decide on appropriate study design and statistical methodology - Responsible for comprehensive protocol review - Responsible for randomization schedule, sample size and power calculations

- Responsible for assuring that data for statistical analyses are accurate STATISTICAL ANALYSES - Responsible for implementation of protocol methodology and statistical analysis plans - Responsible for the accuracy and timeliness of statistical input into reports or decisions

- Responsible for validity of alternative analysis strategies when changes to planned analyses are needed - Responsible for computer programs that are accurate, efficient and well documented - Demonstrates extensive understanding of statistical concepts and methodologies

SCIENTIFIC REPORTS AND PUBLICATIONS - Responsible for Statistical Methods section - Responsible for accuracy of statistical tables and data listings, and accuracy of report text

- Identifies and corrects flaws in interpretation of results, inconsistency in presentation or inference - Provides significant and timely input to the development of a report strategy CONSULTATION

- Works collaboratively with peers to develop efficient designs, quality protocols and reports per agreed timelines - Provides accurate and timely answers to routine questions from clients, and scientific insight when answering nonstandard questions

- Effectively presents statistical concepts and arguments to management TRAINING, SUPERVISION, MENTORING - Effectively mentors less experienced statisticians - Can provide formal training to non-statisticians

- Seen as a project leader on key initiatives Project Coordination and Regulatory Activities - Coordinates and leads the work of the section in multiple project areas ensuring that statistical

5/24/2015 11

support meets regulatory needs - Effectively interacts with project leaders and regulatory affairs Responsible for the accuracy and appropriateness of statistical input (e.g., protocol design, statistical methodology, interpretation of results and inference) provided for regulatory submissions, discovery and development decisions Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.

Responsible for statistical methods Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, and adherence to Abbott report guidelines. Provides meaningful input to the development of a report strategy.

Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines. Provides accurate and timely answers to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data.

Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles. Can clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner. Effectively mentors non-statistical peers with regard to basic statistical methodology and departmental

operations.

Position Accountability / Scope

Position interacts with customers from throughout the division. Often required to reconcile multiple and potentially conflicting priorities. Effective communication with various levels of personnel is required

regularly. Problem Solving: Works collaboratively with multiple stakeholders to develop scientifically appropriate development

strategies per agreed upon timelines. Communicates an understanding of product development principles for assigned projects and acts in accordance with those principles. Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, scientists and nonscientists. Minimum Education

Advanced degree (MS, MA, PhD. or equivalent) in Statistics or Mathematics

5/24/2015 12

Minimum Experience / Training Required MS/MA with 3+ years related work experience or PhD with 1+ years of related work experience. ************************************************************************* Contact Details Contact Name: Margaret Contact Email: Mgwong11@peoplepc.com Website:

http:// Sr. Quality Engineer-- Posted Fri, 05/01/2015 - 4:24pm by margaret.wong

Job Info Job Title: Sr. Quality Engineer Company:

Providence Location: 20 min from Berkeley in the East Bay Job Type:

Full-Time Experience: 05-10 Years Status: Active

Job Description Job Description: • Ensure QMS including quality of products are implemented and maintained in accordance with US FDA and international standards and regulations.

• Lead CAPA and NC program to ensure timely processing and closure. • Use engineering principles to guide quality decisions such as statistical analysis or DOE to identify sources of variation affection products and processes and provide direction for CAPA or process improvement activities.

• Host or participate in MRB to ensure timely disposition and problem resolution. • Guide IQC on resolving daily incoming, WIP, and final inspection issues. • Review and approve DHRs and ECOs. • Process Providence document control and complaint entries and investigations.

• Perform quality system audits as requested or required. • Establish quality inspection criteria and requirements including but not limited to generating SOPs and work instructions. • Implement and improve methods of process control.

• Generate, analyze, maintain, and report quality metrics to QA Department • Implement and improve methods of process control. • Provide written and oral reports to managers or other personnel to keep them informed of day-to-day activities and results. • Other duties may be assigned.

Experience Required: • 4 – 5 years of Quality Engineering and medical device cGMP experience. • Conducted quality system audits in previous companies.

5/24/2015 13

• Experience with sterilization validation desired. • Must be familiar with FDA QSR and ISO 13485 quality system requirements. Education Required: • 4-year B.S. degree in Mechanical, Manufacturing, Quality Engineering or relevant discipline. • ASQ Certified Quality Engineer preferred. ************************************************************************ http://www.indeed.com/viewjob?jk=144e6cb276d2f7f2&q=life+science&l=california&tk=19kg21icdb9kidtr&from=web&advn=9119730075307414&sjdu=Ljv2msLgHY9wHyBkCp06HSx4SKaqirDHQq5uf-BHAhS2hoYnLcJgoLeoOzxOxARLuPgYgVd8B6Krc2Dv3XHPVC6t-97yWCj7Sspvozcya7-nVj4vlEPz4tquAP5jBiqR2VIrYEUucNeI5KvapDDM_w&pub=pub-indeed Project Manager, Life Sciences Integrated Project Management Company, Inc. - San Francisco, CA Project Manager, Life Sciences - San Francisco, CA

IPM is a project management consulting firm that advises on and executes companies’ most complex initiatives. We take our client’s vision or challenge and transform it into an actionable roadmap and provide an onsite leader to drive the initiative through completion. With careful planning and rigorous execution, we help clients meet their goals and sustain them– efficiently, cost-effectively, and often ahead

of schedule. Headquartered in Chicago with offices in Boston, Newark, Los Angeles, Minneapolis, St. Louis and San Francisco, IPM has led more than 3,500 projects for 250 clients in the United States and across continents. Our clientele ranges from Fortune 100 companies to startups. Tackling the most complex projects, often for highly regulated industries, we have compressed timelines by as much as 50%,

streamlined operations to generate millions of dollars in cost savings, secured timely FDA approvals, and led global product-recall projects. Our Project Management Consultants are our full-time employees. They are our most important

asset and the competitive advantage that sets us apart from the rest. They have experience in one or more of our industries, adapt quickly to new environments, and above all are strong LEADERS. Such distinction has enabled IPM to grow rapidly, earning us recognition for six consecutive years as one of Inc. Magazine’s 5000 fastest growing private companies. We plan to continue to grow and seek exceptional talent to be part of our successful team.

Job Roles and Responsibilities Job Description As a Project Management Consultant, your primary goals and focus will be to:

Integrate into client environment to effectively lead project teams while building positive

professional relationships with clients and associates. Define project objectives, requirements, and assumptions necessary to structure a project or

activity. Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements.

Develop and drive integrated project plans, aligning project tactics with project strategy. Establish, maintain, and lead high performance project teams, serving as the project advocate

within the client organization. Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on

project goals and deliverables. Lead risk management within project teams, ensuring risks have appropriate mitigation and

contingency plans.

Job Responsibilities The Project Management Consultant will spend 80-100% of the time at the client facility. In order to satisfy this requirement, travel outside the local area may be required. To ensure appropriate support from your colleagues and the perpetuation of our special culture, our Consultants reside near one of our six offices.

The Project Management Consultant will also: Manage projects within established scope, schedule, and budget while meeting and exceeding IPM

project management standards. Develop and document high-level strategies for accomplishing specific project objectives.

5/24/2015 14

Facilitate and lead effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity.

Support project management team members to ensure success of projects while maintaining customer service focus.

Additional Information Required Skills and Knowledge

Strong interpersonal skills. Strong analytical capabilities. Strong technical aptitude and displayed ability to grasp a general knowledge of multiple disciplines

and technologies. Displayed potential to grasp strategic concepts and strategy development skills. Ability to effectively organize and structure activities. Ability to lead and facilitate multiple activities and resources. Good general understanding of business and financial principles. Professional and effective written and oral communication skills in the English language. Demonstrated work ethic, integrity, and professional conduct.

Basic computer usage skills. Required Experience and Training

Bachelor’s degree or higher. Advanced degrees a plus.

3-20+ years of industry experience related to the pharmaceutical, biotechnology, and/or medical device industries.

3+ years of project management experience related to one or more of the following: product development and launch, business process optimization, technology transfer, regulatory

submission/regulatory compliance, quality assurance, and/or alliance management. Knowledge and application of a disciplined project management process (Six Sigma and PMP

certifications are a plus). Working Conditions

Intrastate, interstate and international travel may be required. Benefits •Full-time employment with a growing company whose management is committed to job stability •Bench time in between projects dedicated to personal and professional development

•Formal new hire orientation to position you for success •Paid vacation, holiday and sick time •Annual performance bonus potential •100% employer-paid health, dental, and life insurance coverage for employees and their families

•401(k) matching •Business development incentives •Philanthropy driven culture •Paid training and certification

•100% promotion from within •Quarterly social activities •Cell phone reimbursement •Assistance with relocation

6 days ago - save job - original job

**************************************************************** Contact Person Angel Romero President – Global Recruiter of West Palm Beach 561-422-5150

aromero@grnwestpalmbeach.com Sr. Director Instrument Manufacturing – CA - #1927

5/24/2015 15

A leading global medical technology and diagnostics company that makes and sells medical devices, instrumented systems and reagents is seeking a Sr. Director, Instrument Manufacturing to develop and lead a high performing leadership team. Key Duties, Activities and Responsibilities: The Senior Director of Instruments Manufacturing leads all aspects of Instrument manufacturing across multiple manufacturing locations in the U.S. and Singapore. Specific areas of responsibilities include developing and executing operations strategy, directing and coordinating production, supporting new product and process development and implementation, engineering, product quality, cost improvements, order fulfillment, materials management, employee development, and environmental health and safety. The Senior Director of Instruments Manufacturing is responsible for developing and leading a high performing leadership team, comprised of leaders with the necessary skills to achieve business goals. This operations leader is a key member of the Company’s Operations Leadership and represents all worldwide operations activities for the Instruments business.

· Develops and executes comprehensive short term and long term strategies and plans for Instruments manufacturing to achieve business goals

· Oversees and directs plant operations for multiple plants, including manufacturing, production control, engineering, materials management, inventory control

· Defines goals, improves technologies and resolves problems in conjunction with Plant Leaders and managers within his/her organization and in other organizations

· Translates customer requirements into state-of-the-art manufacturing strategies and processes, resulting in cost efficiency and profitable manufacturing of products

· In collaboration with his/her plant managers, develops plant and capital budgets, headcount plans, metrics and other measures and controls necessary for operational efficiency

· Plans, directs and oversees the execution of a cost reduction project portfolio, using engineering, lean manufacturing and six sigma techniques

· Formulates and modifies policies and procedures related to plant operations as needed · Defines and drives continuous improvement activities to improve operational effectiveness

· Collaborates with other functional heads (i.e. R&D, Quality, Regulatory, Service) to define and implement cross functional strategies to improve the ‘customer experience’

· Collaborates with all functions to ensure effective development, transfer, introduction and support of new products and processes within the Global Product Development System framework.

· Directs projects focused on the development and implementation of strategic plans.

· Develops framework and business models enabling prioritization and approach on major strategic issues.

· Demonstrates leadership at the world wide operations level and supports the development of strong leadership behaviors within his/ her organization.

· Defines and facilitates communication throughout his/her organization and promotes an environment of collaboration, learning and transparency.

· Develops and implements organizational plans and actions to improve capability, competency and engagement, necessary for fostering high performing teams

· Ensures development of strong succession plans. · Complies with all GMP, regulatory and ISO guidelines including company policies and

departmental procedures · Ensures safety compliance is achieved throughout his/her organization.

Work Experience, Skills and Education Required:

· Broad business acumen in the areas of manufacturing, engineering, customer service, management, environmental health and safety, finance, materials management, and product

quality · Advanced knowledge of the operations function, especially pertaining to customer expectations

for service support and order fulfillment · Expert working knowledge of manufacturing plants, and knowledgeable in contemporary

technology and manufacturing trends

· Anticipates and addresses customer needs as the first priority · Possesses strong strategic abilities and has demonstrated the ability to develop a vision and

drive for successful attainment of that vision · Bold, innovative and willing to take calculated risks

5/24/2015 16

· Effective analytical, quantitative, technical and problem solving skills, including business and financial analyses.

· Strong leadership, interpersonal, organizational, collaboration and project management skills. · Resourceful, able to inspire action and achieve results through others · Demonstrated change management skills. Ability to work with others from diverse backgrounds

and different cultures. · Demonstrated ability to effectively work with, present to and influence senior management in a

cross-functional, matrix, global environment. · Excellent written and oral skills, and strong facilitation and negotiation skills · Demonstrated ability to effectively work with ambiguities and rapid changes. · Has a passion for developing talent utilizing creative and effective programs and practices and

has successfully demonstrated the ability to attract, develop and retain a diverse team · Demonstrated ability to promote teamwork and motivate and manage senior managers, line

managers and individual contributors · Strong inclination and passion for continuous improvement.

__________________________________________________

Product Manager – CA - #1909 While striving to deliver top notch advancements in Spinal Fusion Technologies our client is committed to delivering safe, effective and innovative products that exceed expectations while meeting all regulatory requirements through their commitment to continuous improvement and quality excellence. They are in

search of a Product Manager to join their team. Key Duties, Activities and Responsibilities:

· Identify and implement product strategies, marketing plans, promotional and advertising

programs. · Oversee all aspects of product management, market launch and surveillance, release to sales

and forecasting to ensure that existing and new products meet Company goals and expectations. · Develops product marketing plans, including objectives, short-/long- term strategies, market

research, competition, product mix, action plans, and ROI analysis. · Manages all product marketing activities for specific product line, including new idea generation,

product profiling review, product strategic development plans, project management as well as market launch and surveillance.

· Pursues product line extensions and/or trimming, labeling revisions, clinical studies and any

other activities that would ultimately build and sustain value of the product line and maximize earnings.

· Continually seeking new innovations for assigned product line. · Helps develop quality collateral sales materials, efficient customer service processes, and

optimized manufacturing operations to support assigned product line. · Monitors forecasts as necessary and works collaboratively with other departments to optimize

product mix throughout product lifecycle. · Monitors competitive landscape to stay abreast of market trends by regularly reviewing

scientific literature, competitor’s product offerings, and traveling with field sales personnel, attending surgeries, meeting with stakeholders scientific meetings, etc.

· Develop product presentations, surgical techniques, and white papers in support of sales and corporate marketing programs, e.g. product binders, web sites, brochures, etc.

· Monitors product development progress and seeks input from engineering, manufacturing, regulatory affairs and other relevant departments to ensure product strategic plan is completed efficiently.

· Collaborates responsively and proactively with sales to ensure quality product support of new

product launches, existing product segments, training programs, and key surgeon/key account management.

· Establishes and maintains strong relationships with designing and consulting physicians. · Maintains a strong market position of assigned product line through a highly visible presence

and public relations at scientific conferences and meetings.

· Routinely interfaces with Company managers/directors of other product lines to fully understand the interdependent relationship between product portfolios.

· Supports the Company’s Medical Training department by assisting in the preparation and running of surgeon training courses that may include didactic and cadaver labs.

5/24/2015 17

· Works collaboratively with communications and other related departments to develop creative promotional, advertising and value-added services to maximize revenue.

· Performs other duties as required.

Work Experience, Skills and Education Required: · Bachelor’s degree in Marketing or related field with 5+ years of related experience, spine

experience required; or MBA and 3+ years of related experience; or equivalent combination of education and experience.

· Spine experience is required. · Proven skill and experience in overall market analysis, planning, development and

management. · Strong technical as well as conceptual aptitude. · Strategic/tactical planning and implementation capabilities. · Excellent oral and written communication skills. · Technically sensitive and receptive.

· A demonstrated capacity for strategic thinking, planning, marketing and product development. · Knowledge of computer applications (i.e.: Microsoft Word, Excel, PowerPoint, Access & Project,

Windows, Internet applications, etc.) required. · Experience with and understanding of a clinical/surgical environments and workflow.

· Superior interpersonal skills. · Ability to organize and prioritize workflow and to meet established timeframes. · Ability to work within a cross-functional team and matrix management structure. · Strong attention to details.

· Ability to maintain updated knowledge of procedures, products and activities of assigned product line.

· Ability to perform multiple tasks in a fast-paced, team environment. · Average travel requirement is approximately 30 percent.

__________________________________________________

Global Regulatory Affairs Director/ Sr. Director- CA #1782 A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for a Global

Regulatory Affairs Director for its California location Key Duties, Activities and Responsibilities: The Director, Global Regulatory Affairs will be responsible for directing and managing regulatory project

management and logistical activities in relationship to global regulatory submissions for IVD systems (assays, instruments, software). The Director will also serve as regulatory subject matter expert for design control, development and compliance projects. The Director will be responsible for a group that prepares and maintains regulatory documentation for submission to US and international regulatory

authorities. These submissions may include Biologics License Applications (BLAs) and related Supplements and Amendments, Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs), new registrations, variations, and export notifications, as well as responses to requests for information. This position will supervise representatives of the Regulatory Affairs group on

project teams to support new products and projects and provide regulatory strategy, risk assessment, and review of project documents, products and R & D programs.

Direct/manage regulatory project management for all regulatory projects in his/her group Direct/ manage/ supervise the preparation of regulatory submissions for US and applicable foreign

regulatory bodies for in vitro diagnostic and/or biological products Global responsibility for representing Regulatory Affairs at Divisional and Business Unit meetings on

design and development, post-approval marketing and partner company project teams Assume a leadership and expert role in the completion of submissions Supervise the activities of regulatory managers and associates as appropriate by product category

Formulate regulatory strategy for assigned products and projects Solve problems and make decisions in a cross-functional team setting Supervise the management of key partner and critical vendor relationships as appropriate to

ensure compliant submissions

5/24/2015 18

Participate on multidisciplinary teams focusing on continuous improvement and management initiatives

Demonstrate strong verbal and written communication skills Organize and prioritize work assignments across his/her group Work independently and closely with colleagues of various responsibilities and educational levels

throughout the company Initiate appropriate actions when individual decisions impact other aspects of the business Provide regulatory counsel for internal and external programs (affiliates) associated with

advertising and promotion company products. Manage projects to budgets and timelines and provide leadership in non clinical, clinical, or other

areas. Participate in review of product changes post approval. Independent reviewer of regulatory applications. Work with regulatory team to develop and implement a promotional review program. Liaison with Marketing/Regulatory/Medical/Sales and Legal (internal) for the review of advertising,

promotion, abstract and scientific papers and presentations.

Establish and maintain training program for the regulatory staff. Work Experience, Skills and Education Required:

Bachelor’s Degree in Life Sciences, Physical Sciences or Engineering required/Master’s Degree

preferred Additional training in Regulatory Affairs (e.g., Graduate or Certification programs) preferred Minimum 7-10 years of experience in regulatory affairs and/or compliance Experience with developing and obtaining regulatory approvals for biomedical hardware and

software Knowledge of US FDA and global registration requirements for IVDs and medical devices Knowledge of US FDA Quality Systems regulations, EN ISO 13485, and the EU IVD Directive Strong leadership and mentoring skills

Proficient with Microsoft Office software Outstanding verbal and written communication skills with an ability to foster close and productive

working relationships across the organization Excellent project execution skills with an ability to multitask and prioritize in a fast-paced

environment

__________________________________________________

Systems and Applications Scientist – CA - #1890 Our client is a global leader in the development and commercialization of new immunology technologies

and diagnostic markers. They are a nimble, small niche firm that has experienced consistent growth in sales and size in the last few years, and is expecting to continue its steady growth. They are on the verge of taking a commanding market share and they plan to accomplish this through a strong team of capable people, a persistent focus on customers and quality, and by leading the field with new product innovation.

Key Duties, Activities and Responsibilities: The Systems and Applications Scientist will be responsible for installation, training, maintenance and

troubleshooting of the company’s system. This role will also entail ongoing technical and applications assistance in response to customer and global affiliate/distributor inquiries. This position will require domestic and international travel with overnight stays, up to 30% of the time. May be required to travel to customer sites with as little as 24 hours notice and must be willing to stay at customer sites for several

days at a time.

· Performs services and application training, customer training and product demonstrations tot external and internal clients as needed.

· Provides telephone, email, and on-site technical support.

· Must have strong troubleshooting skills for mechanical, applications, LIS/Interfacing and assay related issues. Must be proactive in resolving instrument issues before they become chronic by escalating them to proper sources, determining a root cause and course of action.

5/24/2015 19

· Must have excellent customer interface skills and ability to provide best-in-class support and service to the customer base.

· Must be able to maintain records and reports as required, coordinate activities with peers, manager and customers to minimize equipment downtime and interruptions. Orders and install parts, responds to emergency service calls as required. Effective time management skills are requires.

· Writes/updates any instrument validation protocols in compliance with Quality Systems requirements. Coordinates validation protocols and processes (SW and HW) with appropriate internal departments (e.g., Quality, manufacturing, etc.) to ensure optimization of time, resources and results.

· Ensure proper communication and documentation for product complaints per SOP and FDA regulations.

· Monitors and prepares periodic instrument performance reports. · Acts as primary contact for the manufacturer on quality and performance issues, parts list

maintenance and warranty parts returns. · Remain current on equipment/tools through appropriate training, manuals, factory technical

bulletins and other relevant materials and resources. · Must have strong technical writing skills and be able to edit technical notes in addition to writing

or updating training manuals for Field Service Engineers as well as for customers. · Must have the ability t read and understand technical drawings, specification as well as

comprehension of the maintenance and servicing of large laboratory equipment. · Responsible burning in and refielding the systems. · Other duties as assigned.

Work Experience, Skills and Education Required:

· Bachelor’s degree B.A. or B.S. in biological or related sciences with 4-8 years of in vitro

diagnostics system support experience. · Relevant work experience may be substituted for a degree. · Good laboratory skills. · Knowledge of and ability to perform immunofluorescence and ELISA procedure are desirable. · Good oral and written communication skill and computer skills are required.

· Ability to read and interpret documents such as safety rules, operating and maintenance instructions, scientific journal articles, technical documents, procedure manuals, and Standard Operating Procedure (SOPs)

· Ability to speak effectively before groups of employees, customers and distributors and

effectively represent the corporation to outside visitors. · Ability to add, subtract, multiply and divide in all units of measure, using whole numbers,

common fractions and decimals. · Ability to calculate concentrations, dilutions, proportions, percentages, rate, ratio and percent

and to draw and interpret bar graphs. · Ability to solve chemistry and dilution equations. · Ability to apply concepts of algebra, geometry and statistics to work related problems. · Ability to define problems, collect data, establish facts and draw valid conclusions.

· Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variable.

· Ability to design, conduct, interpret and report results of experiments.

__________________________________________________ Technical Account Specialist II – Bay Area - #1942 A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for a Technical Account Specialist II. Position is based in the Bay area.

Key Duties, Activities and Responsibilities: Compliance – Adhere to procedures and protocols outlined by the companies Technical Support

organization and the Company. Provide Customer Service/ Account Management including:

5/24/2015 20

o Customer Liaison between company departments and the Customer Site. o Implementation of new customers o Upgrade to Equipment or Software o Technical Review. o Daily Operations/Troubleshooting o Site Workflow Analysis o Customer Date Collection and Analysis at county/sector level

Project Implementation including: o Ensure strong communication within the Company and the customer site o Develop advanced and comprehensive project plans o Participate in New Product Launches

Assist Sales Executives with presentations and analysis to increase customer portfolio Assist with training new employees (TSA/FSE Hybrid) within department Provide document translation & verification Assist Sales team in commercial offer documentation Personal Development – continue to enhance presentation, communication and project

management skills. Work Experience, Skills and Education Required:

Bachelor of Science in Medical Technology and immunohematology background with an SBB

licensing preferred. High-Level of performance as a TAS I and/or 3-5 years experience in blood testing customer

service/technical support Demonstrated Project Management

Presentation Skills required. Excellent organization, record keeping and inventory skills required. Knowledge of GMP, ISO and other certifying agency policies and regulations preferred.

Proficient with Microsoft applications and familiar with computerized call handling systems preferred.

Excellent analytical and troubleshooting skills. Self-motivated and self-directed, with strong interpersonal and communication skills, and the

ability to communicate technical information effectively. Position and will be based in the field with up to 70% travel required. Candidate must have ability

to travel outside assigned geographic area as needed. Will cover additional geographic regions to

facilitate significant service requirement of customer base. Work hours are flexible, not conforming to a standard 40 hour work week; candidate must be

accessible for contact by phone. Candidate will work from a home office. __________________________________________________

Senior Systems Engineer - #1810 A major global screening, molecular diagnostics and biotech company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for an

Senior Systems Engineer. Key Duties, Activities and Responsibilities: • Lead development of IVD systems, from requirements through design and implementation, through validation and to customers.

• Define the architecting of systems solutions. • Contribute to the drafting and review of development agreements with outside partners and vendors. • Oversee outside partners and vendors work and progress towards developing IVD system products, including prototype testing, defect reviews, design reviews, V&V

• Work with Global Marketing in the development of customer requirements, and develops product requirements using requirement management methodologies, including change management. • Work with internal stakeholders to facilitate the collection of business and regulatory requirements. Ensure alignment of customer and business needs. • Develop system level product requirements and component requirement documents.

• Define and prepare a schedule of development tasks. • Mentor others on systems engineering best practices and procedures. • Conduct patient safety risk management activities according to FDA and ISO regulations. • Establish product configuration management.

5/24/2015 21

• Plan and perform integration testing. Establish software ad-hoc testing strategy. • Support verification and validation activities. • Present and document work product to meet needs of project and business. Work Experience, Skills and Education Required: · B.S. Degree in Engineering and/or Science: advanced degree preferred. · 5+ years of relevant experience developing IVD integrated system based diagnostic products. · Experience with leading development efforts in a cross functional environment · Ability to solve complex systems issues and problems · Experience with Laboratory Information Systems (LIS) is a plus · Demonstrated software product development experience, using lifecycle methodologies. · Strong knowledge of best practices of development under FDA design control. · Possesses project leadership skills in managing priorities, delegating, and influencing others. · Ability to convey very complex information in both written and oral form. · Experience with managing external vendor relationships. · Ability to influence others, gain acceptance and build consensus. · Strong written and oral communication skills.

· Knowledge of molecular biology is a plus. __________________________________________________ Director R&D Immunochemistry – CA - #1824

A major global screening, molecular diagnostics and Biotech Company that manufactures and markets blood diagnostics and screening instrumentation, reagents and software systems is searching for an Director R&D Immunochemistry. Position is based in the Bay Area, CA. Key Duties, Activities and Responsibilities:

The Director will be responsible for research and development of Immunodiagnostics assays which encompass conception, design and execution of recombinant protein / antigens expression and purification and their use in Immunoassays. Identification and development from third party biomarker for the companies immunosystem falls within the scope of the job. The Director will also directly manage the

Research group. In collaboration with the companies System Engineering, Marketing and Business Development, this position is pivotal to the success of the Immunodiagnostics business.

Lead the Immunochemistry group with a focus on technical competency, verbal and written

communication, teamwork and problem solving. Responsible for effective transfer of recombinant antigens and Immunoassays to manufacturing Develop talent and leadership within the Immunochemistry group. Foster communication and networking across the broader of Diagnostics R&D group such as

technical Operations, System Engineering, Business Development and Marketing Establish and oversee together with BD productive research and development collaborations and

ensure that the efforts of partners are well supported, aligned with internal priorities and objectives.

Build a best-in-class Immunochemistry R&D organization that fully utilizes know-how, knowledge exchange and industry wide best practices, including continuous lessons learnt and constant process improvements.

Ensure full compliance with international, internal and external quality standards like GCP, GLP and

other quality standards. Manage people and resources optimally within budget. Through publication in scientific journals and presentation at for Diagnostics relevant meetings

established the reputation for the company as a innovative leader

Provide guidance and coaching to team on development and technical levels. Work Experience, Skills and Education Required:

PhD in Biochemistry, Chemistry, Biology or other life science field 8-10 years R&D leadership experience in Diagnostics industry

Extensive experience in immunoassay development Solid knowledge in Molecular Biology with emphasis on cloning and expression of peptides and

proteins as well as protein purification

5/24/2015 22

Proven track records of managing immunoassays advancing through development registration and commercial launch

Previous experience managing Scientist level staff Excellent interpersonal and communication skills __________________________________________________

Software Engineer, System Engineering – CA - #1956 Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major healthcare institutions worldwide. They are searching for a Software Engineer, System Engineering. Key Duties, Activities and Responsibilities: The Software Engineer in Test in the Systems Engineering team shall develop and support in-vitro diagnostics (IVD) systems with an emphasis on software based projects. As software engineer in cross-functional project teams, he or she will responsible for participating in software development, test planning, test development, and test execution for all vendor supplied and custom built software solutions. The position focuses on window based application development testing currently and later will transition to web based development and testing effort. The ideal candidate is a self-starter, confident, creative and

detail oriented. The target applications include laboratory data management systems and many others related to the business

· Contribute to development of software, from requirements through design, implementation, and

validation and release to customers. · Contribute to the architecting of software systems solutions for in-vitro diagnostics systems and

interfaces to other diagnostic lab systems and LIS. · Perform various types of testing including automated testing, data input/output validation, range

testing, navigation, security, data integrity, performance, usability, compatibility with all supported configurations, and regression testing

· Plan and develop automated testing framework and test suits. · Plan and perform system, integration and unit testing.

· Support verification and validation activities. · Document and present work product to project team and business stakeholders. · Develop user instructions and training materials for the product developed. · Recommend changes to match user expectations with application functionality

Work Experience, Skills and Education Required:

· Bachelors Degree · 3+ years of relevant software engineering test experience with an in depth understanding of

windows and web applications. · Experience in a cross functional environment.

· Capability to work with aggressive timelines; Flexibility in adjusting schedules to meet demanding deadlines;

· Able to multi-task; Excellent communication skills; Capability and desire to be a strong team player in a small to medium sized team that often requires flexibility, creativity and open

mindedness; · Capable of contributing in the instating of software development best practices. · Applicants must have critical thinking capability and be able to identify, document, and

reproduce technically oriented problems.

· Experience with different software development processes, QA methodologies, and test management tools are important.

· Experience with Windows application development and testing is a must. · Experience in database based software development and testing.

· Experience with test automation development. · Experience testing medical software and experience with laboratory systems is a plus.

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

Apply URL: https://MYBAYERJOB.BAYERBBS.COM/sap/bc/erecruiting...

5/24/2015 23

Associate Manager, Distribution & Warehouse Materialsl Management

Job ID: 23568894

Position Title: Associate Manager, Distribution & Warehouse Materialsl Management

Company Name:

BAYER

Location(s): Berkeley, California, 94704, United States

Posted: May 2, 2015

Job Function: Other

Entry Level: No

Description Associate Manager, Distribution & Warehouse Materialsl Management Bayer is a global enterprise with core competencies in the fields of health care, agriculture and high-tech polymer materials. As an innovation company, it sets trends in research-intensive areas. Bayer's products and services are designed to benefit people and improve their quality of life. Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Divisions include Specialty Pharmaceuticals, Medical Care, Consumer Care and Animal Health. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. Warehouse & Materials Mgmt Bayer offers a wide variety of competitive compensation and benefits programs. If you

meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. 1. Provide effective leadership including: individual goal setting/performance reviews; training and coaching employees; ensuring appropriate staffing levels are

met, effectively managing employee performance issues and corrective actions; recognizing and appreciating employee contributions, supporting workforce diversity, quality and safety, and all other activities/functions which support achievement of individual/department/business objectives. Accurately administer hourly time and attendance. Demonstrate a general understanding of pay practices and assist

employees with any necessary troubleshooting. 2. Coordinates and ensures physical transfer of frozen intermediates to production buildings. 3. Coordinates and ensures flow of Raw Materials to the active Production buildings. 4. Ensures the proper storage conditions for all raw materials, intermediates and final product. 5. Supervises the use of the current Inventory Tracking System (SAP) 6. Work with Inventory Planner for execution of Cycle Counts and Annual Warehouse Physical Inventories. 7. Responsible for the receiving process for inbound Raw Materials by scheduling deliveries of raw materials, meeting key performance indicators for receiving times and holding employees accountable for following receiving SOP's and procedures. 8. Responsible for GMP and Safety compliance in Warehouse. Complying with all department and site safety policies and practices. Meeting all safety related KPI's and reporting and resolving potential safety issues. Responsible for cGMP's for all direct reports making sure all SOP's are in compliance with Bayer Directives, Code Of Federal Regulations and site SOP's. Minimum Education: BS Minimum Experience: BA/BS 6+ years MBA/MS 2+ years PHD 0-2 years of experience of supervising in a Warehouse operation, preferably in a Biotech Industry or equivalent combination of education and experience. Special Skill/Knowledge: - Experience in FDA controlled distribution systems (Receiving, Warehousing, and Shipping) - Exposure to Pharmaceutical controls. i.e. current Good Manufacturing Practices, Production and Inventory Control and Electronic Data Processing Bayer is an Equal Opportunity Employer Minorities/Females/Protected Veterans/Disabled

Your application We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first

day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.#

5/24/2015 24

www.myBayerjob.com Phone +1 877 229-3727 Bayer is an Equal Opportunity Employer PI89950040

Apply URL: https://MYBAYERJOB.BAYERBBS.COM/sap/bc/erecruiting...

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

See regulatory jobs at FDLI Smartbrief. FDLI launches the new FDLI Career Center. Search produces 7 positions in CA at http://careers.fdli.org/jobs?keywords=california

Diagnostic Microbiologist San Bernardino, California California Animal Health & Food Safety Laboratory System 1 Month Ago

Regulatory Coordinator I-19330 Los Angeles, California Cedars-Sinai Medical Center 1 Month Ago

Regulatory Coordinator II Los Angeles, California Cedars-Sinai Medical Center

3 Weeks Ag0 19476 Regulatory Coordinator II-19476 Los Angeles, California

Cedars-Sinai Medical Center 3 Weeks Ago Regulatory Coorindator I

Los Angeles, California Cedars-Sinai Medical Center 1 Week Ago

Research Program Administrator Los Angeles, California Cedars Sinai Medical Center 2 Months Ago

Affiliate Program Coordinator Los Angeles, California Cedars-Sinai Medical Center 3 Weeks Ago

**************************************************************************** Astex Pharmaceuticals is an Equal Opportunity Employer Job Location - Dublin, CA Job Contact - Laura Hopeman

laura.hopeman@astx.com 925-560-2815 Job Title - Project Manager/Sr. Project Manager Contractor

Organization - Astex Pharmaceuticals Job Description - Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc.,www.astx.com, brings together high tech and biotech to discover and develop more

5/24/2015 25

effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This position will be based in the corporate office located in Pleasanton, California near the Dublin-Pleasanton BART station. The Project Manager/Senior Project Manager Contractor will be responsible for managing Astex Pharmaceutical’s late-stage clinical drug development projects. This role will support the Project Management Department working with the project team members to define, plan, and schedule activities to satisfy the project objectives, and work effectively within a diverse and global environment. This is a contract position with a term of a minimum of 12 months. Responsibilities: • Support the Project Management Department to generate, track, and control project activities, and ensure coordination of activities between all departments • Clearly and proactively communicate progress, issues or deviations that may impact the project

schedule, timelines, and costs • Support the Project Management Department working with the team members to identify critical path activities, resource constraints, risks and conflicts that may impact the project schedule, timelines, and costs

• Facilitate effective project team meetings including the creation of effective meeting agendas and clear documentation of meeting discussion points and decisions • Where appropriate, maintain and communicate a current overview of project status and issues, and assist in budget development and tracking

• Maintain online project documentation Job Requirement - Requirements:

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred) • Advanced degree and/or PMP certification desirable; PMI certification is a plus • Minimum 4 years’ experience in pharmaceutical drug development, preferably oncology • Minimum 2 years’ experience managing Phase 2 and 3 stage drug development projects and cross-functional project teams

• Experience managing international teams is desirable • Highly motivated with the ability to respond quickly and effectively to a changing environment, and adept at influencing others without direct authority • Exceptional planning and organizational skills combined with a broad understanding of late-stage

drug development • Experience with planning and oversight of project budgets • Proficiency with Microsoft Word, Excel, Project, PowerPoint, and Visio

********************************************************************** Jobs That Crossed My Desk Through May 3, 2015

****************************************************************** Jobs at QB3 companies appear below.

SENIOR BIOINFORMATICS SCIENTIST, Miroculus POSITION DESCRIPTION

Miroculus is inviting applications from experienced bioinformaticians with strong computational background and expertise in non coding RNA biology. The senior bioinformatician will design and implement algorithms that support goals of project teams. This position reports to the CSO and works closely with the executive team.

We are looking for creative and highly motivated individuals who can design traps for specific RNA targets. For this, it would be good to have experience with miRNA or RNA calculations, folding and primer design. Experience with functional analysis of small RNA expression profiling data from qPCR, microarray and NGS

5/24/2015 26

is a plus. Our team is international, interdisciplinary, fast paced and used to excellent communication and teamwork skills. The candidate should feel comfortable functioning within a small and rapidly growing company. REQUIREMENTS: Ph.D. in bioinformatics, biostatistics, computer science, or a related discipline Solid biostatistical knowledge and practical experience using bioinformatic applications Experience with miRNA or RNA calculations and folding Computational Biology, Bioinformatics, Biomedical Data Analysis Strong programmatic skills in languages such as Perl, Python, R, Java, C/C++, database querying

languages (SQL) BENEFIT TO HAVE:

Primer design and evaluation NGS (including RNA-Seq, small-RNA-Seq, ChIP-Seq, CLIP-Seq, etc) data analysis and integration.

Experience in design and implementation/development of novel algorithms and automated pipelines to support large-scale bioinformatics analyses Functional data interpretation, network design and biological systems modeling (e.g. co-regulated gene

networks linked with biological pathways) Non-coding RNAs (miRNAs) and post-transcriptional regulation mechanisms. LOCATION

Full time position in our lab space at QB3 in San Francisco If you would like to apply for the Senior Bioinformatics Scientist position, send us your bio and

publications at jobs@miroculus.com ________________________________________________________________________________ Two positions: Mission Bio

1. Scientist (Molecular Biology), Mission Bio OVERVIEW

Mission Bio, Inc. is a startup venture founded on microfluidic droplet-based technology developed at the University of California, San Francisco (UCSF). We provide services and instrumentation that accelerate the investigation of cellular heterogeneity by rapidly and accurately performing single-cell transcriptional profiling and genotyping.

Mission Bio operates out of the QB3 biotech incubator in San Francisco. We are a small team that is growing rapidly, so this is an opportunity to make a significant impact on the direction and success of the company. DESCRIPTION

Mission Bio is currently looking for a highly motivated and qualified individual to assist in the development and commercialization of a platform technology, PCR-activated cell sorting (PACS). PACS will be broadly useful in life science research, allowing users to rapidly analyze and sort large populations of cells based on single-cell multiplex TaqMan reactions performed in microfluidic droplets. This approach will

5/24/2015 27

enable characterization and sorting of heterogeneous cell populations by targeting nucleic acid biomarkers not identifiable with existing sorting technologies. The candidate will primarily focus on optimizing the current platform and enabling downstream molecular characterization of sorted single cells. The successful candidate will also assist in early stage research into future single-cell genomic and transcriptomic technologies aimed at expanding the Mission Bio product portfolio. QUALIFICATIONS • We are looking for a motivated and independent scientist who is excited by the opportunity to make an impact at a fast-paced, multidisciplinary startup environment • Must be detail oriented and highly motivated to do bench research. Research excellence must be demonstrated through publications, presentations and other accomplishments. • Ph.D. in molecular biology, biochemistry, cell biology or similar discipline. • Extensive molecular biology experience is required. Examples include: nucleic acid amplification

strategies, primer design, next-generation sequencing and other methods for gene expression analysis. • Experience applying the above molecular biology methods to the analysis of single cells, or knowledge in the fields of genomics and transcriptomics is highly desirable.

• Must be able to design and perform experiments, analyze data, perform troubleshooting and optimize protocols with minimal supervision.

• Experience with basic mammalian cell culture techniques or handling of clinical cell samples considered a plus. • Knowledge of a programming language preferred (e.g. MATLAB, Labview)

• Must be eligible to work in the U.S. Candidates interested in this position should submit their resume to jobs@missionbio.com.

2. Research Associate, Mission Bio DESCRIPTION Mission Bio is currently looking for a highly motivated and qualified individual to assist in the

development and commercialization of a platform technology, PCR-activated cell sorting (PACS). PACS will be broadly useful in life science research, allowing users to rapidly analyze and sort large populations of cells using single-cell multiplex TaqMan reactions performed in microfluidic droplets. This approach will enable characterization and sorting of heterogeneous cell populations by targeting nucleic acid biomarkers

not identifiable with existing sorting technologies. The candidate will primarily focus on running and optimizing the current PACS platform as it is applied to diverse biological applications. The successful candidate will also be called upon to assist early stage research on future single-cell genomic and transcriptomic technologies aimed at expanding the Mission Bio

product portfolio. QUALIFICATIONS • Excited about working in a fast-paced multidisciplinary startup environment.

• B.S. with lab research experience in molecular biology, biochemistry, cell biology or similar discipline. • Must be detail oriented and highly motivated to do bench science.

• Willing to take on a diverse set of lab responsibilities and rapidly learn new methods including microfluidics. • Familiarity with common molecular biology methods like nucleic acid amplification and gene

5/24/2015 28

expression analysis desired. • Must be able to design and perform experiments, troubleshoot and optimize protocols independently. Ability to conduct basic data analysis is also desirable. • We prefer a candidate with biotech industry experience. • Proficiency with basic mammalian cell culture techniques or handling of clinical cell samples considered a plus. • Must be eligible to work in the U.S. Candidates interested in this position should submit their resume to jobs@missionbio.com. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Position: Quality Engineer consultant, Neurosave Requirements: • Driven & hands-on individual who can work with a very small team and have a big impact on the

development process. • Relevant degree in Engineering. • Minimum 4 years in Medical Device/ Quality Engineering / Manufacturing experience. • Considerable hands-on experience in Medical Device R&D strong working knowledge of FDA QSR, MDD

and ISO 13485 & ISO 14971 Risk Management. • Experience with Human Factors, Voice of Customer, ASQ Sampling Plans and Supplier Evaluation & Management a plus. • 60-80% FTE needed

Responsibilities: • Partner with R&D Engineering to develop appropriate development & Design Control documentation for the Medical Device product. • Support preparation of documents and participate in design reviews

• Identify improvements based on relevant risk analysis, past manufacturing experience, and specifications & requirements for products. • Ensure compliance with design controls and ISO13485 • Work with Senior Quality advisors to identify gaps and implement solutions as needed

• Liaise with external Manufacturing partner to ensure successful design transfer and quality product manufacture & release. • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

• Evaluate and implement protocols and methods (including SOP’s) to ensure that incoming material and manufactured products are compliant with internal requirements. Contact Shadi Haag for more information: shaag@neurosaveinc.com

************************************************************************************ How to Apply Please visit http://www.chemocentryx.com/careers/job.html#PAAPA to apply online. All ChemoCentryx employees share the rewards of their work through a generous stock option program.

We also offer 401K and Flexible Spending Accounts, and a comprehensive benefits package, including medical, dental and vision coverage and life and long-term disability insurance. EOE Patent Agent / Associate Patent Attorney

Job ID: 23544571

Position Title: Patent Agent / Associate Patent Attorney

Company Name:

ChemoCentryx

Posted: April 30, 2015 Job Function: Patent Litigation Entry Level: No Job Type: Full-Time

5/24/2015 29

Industry: Biotech

Location(s): Mountain View, California, 94043, United States

APPLY FOR THIS JOB Apply URL: http://www.Click2Apply.net/2r7685v

Save Job Email Job Print Job Apply For Job

Job Description Patent Agent / Associate Patent Attorney

Flexible Title - commensurate with the candidate’s background and experience ChemoCentryx is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered small molecule therapeutics that target the chemokine and chemo-

attractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. We are building a strong pipeline that currently includes products in development for immunological diseases, metabolic disease and cancer. At ChemoCentryx, we are committed to developing innovative therapeutics, cutting-edge technologies and pursuing the highest quality science.

Description DUTIES AND RESPONSIBILITIES

Prepare, file and prosecute U.S. and foreign patent (mainly chemistry) applications Conduct patentability, technology assessments, and clearance searches in areas which may impact

the Company’s intellectual property Support business development efforts, including IP due diligence for prospective opportunities Keep management informed of competitive intellectual property developments and relevant

business advice, including worldwide patent prosecution updates as they affect the company’s

business or opportunities Conduct patent application review meetings with inventors Review responses to US and ex-US Patent Office examination communications drafted by outside

patent counsel Manage outside patent counsel activities and interactions

Process invention assignments and declarations Review and execute material transfer agreements, confidentiality disclosure agreements,

technology transfer agreements and other legal instruments such as contracts Manage external collaborations

Review ongoing scientific developments by the Company’s research and development teams Review abstracts, posters and publications prepared by the Company’s research and development

teams prior to submission EDUCATION AND EXPERIENCE

Bachelor of Science degree in Chemistry (organic/medicinal) or Biochemistry Minimum of 5 years of professional experience in preparation and prosecution of chemistry (mainly

small molecules) and biochemistry/biology patent applications At least 3 years of which were spent as a patent agent or in a related role(s) within a

biotechnology, pharmaceutical or related industry Admission to USPTO as a Patent Agent required Demonstrated knowledge of the domestic and international laws, regulations, and processes

relating to chemistry (mainly) and biochemistry/biology patents and applications

Knowledge of the standard concepts, practices, and procedures of the patent agent function within a pharmaceutical or related industry

Experience using IP software and systems such as ChemDraw, USPTO website, web-based scientific research applications such as SciFinder and docketing, research database and other relevant software

Effective communicator in both oral and written forms Capable of high performance in independent work as well as in team setting

Job Code #22 ***********************************************************************************

Jobs That Crossed My Desk Through April 26, 2015 ********************************************************** Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot. My imminent openings are for Senior Electrical, Mechanical, Quality and Software Engineering – all with

5/24/2015 30

strong medical device experience. Please also notice contract opportunities at the end. All US opportunities are for US based and local candidates. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are. This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia) Director of Mechanical Engineering – San Jose, CA Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon. Mechanical Engineer – San Jose, CA Requires 5+ years medical device experience. Details will be posted soon. Quality Engineer – San Jose, CA Requires BS in Engineering and 10+ years medical device QE experience. Details coming soon. Physiologist – San Jose, CA Requires large animals survival surgery experience. Details coming soon. Biochemist – San Jose, CA Requires PhD + 3-5 years industry experience. Details will be posted soon.

Ruby on Rails Engineer – San Mateo, CA Senior Electrical Engineer – Austin/ San Antonio – TX A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience. Experience with closed loop, analog design hardware,

microcontrollers, actuators and ultra low power consumption circuit design highly desired. Key Responsibilities * Lead Electrical Engineering, primarily for long-term implantable drug delivery devices: * on R&D- design and development of implantable and associated wearable and external hardware using

mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems * Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics * Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and

ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products * Establish reliable suppliers and partners for manufacturing * Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment

* Document work output and use project and organizational documentation systems, including electronic systems * Plan for and support existing and projected growth of the company. Key Qualifications

* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable * Bachelor’s degree in Electrical Engineering or in an equivalent field required

* Led and grown EE groups with a hands-on, leadership- by-example approach * Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters

* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus. * Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-

on re: circuit and system prototyping and development * Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics. * Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical

and business. * Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity

5/24/2015 31

* Analytical data-driven problem solver and team player, organized and an excellent communicator * Supported multiple complex projects in a start-up environment: able to prioritize. Key Job Parameters * Full-time position located near Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities * Report to VP, Product Development Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA A reputed contract engineering company has an immediate full time opportunity for a Senior Design Engineer with Embedded Hardware & Firmware Skills. A rounded individual is desired who has an interest and ability in a wide range of technologies. The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times. The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work. The person must enjoy working with customers and have good communication skills. The person must work well on a team of high performing engineers. The person needs to be organized. The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required. Ability to supervise others is highly desired. The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices. The person must enjoy learning and be able to learn quickly. The ability to

design and program FPGAs is desired. This could be a work-at-home job, or work at the company site, in Santa Clara, CA. QUALITY ENGINEER – Santa Cruz, CA See full description in March Job posting.

Senior Quality Engineer – Austin/ San Antonio – TX A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities: * Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation

* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables * Implement productive relationships with R&D and manufacturing suppliers and partners

* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment * Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and

materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation * Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications * Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable* * Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE,

CQM, CSSBB) desirable * Led and grown QA organizations with a hands-on, leadership- by-example approach * Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.

* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE * Supported multiple complex projects and start-ups: able to prioritize. * Developed and implemented design controls, documentation, and design procedures, protocols * Developed and implemented manufacturability, and related process flows and controls, and selected

5/24/2015 32

qualified vendors to manufacture Class III implantable devices * Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity * Analytical data-driven problem solver and team player, organized and an excellent communicator Key Job Parameters * Full-time position located in Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities * Report to VP, Product Development Contract Opportunities with skills in following areas – San Jose, CA * Electrical Engineering & Software * Analog Design * PCB Layout (FR4, Flex etc.) * ASIC Design * Embedded Systems * TI MSP430, ARM, Cypress * Software (Windows, Linux, C++, Android, iOS)

* Sensors * RF Communications * Bluetooth, Wi-Fi, 3G, 4G, GPS * Antenna Design

* RF Test Labs * Test Engineering * Test Hardware & Software * Manufacturing Engineering

* Fixture Design * DFM, DFT (Design for manufacturing, Design for Testability) * Process Development * Machine Shop Support

************************************************************************************* mp@hechkoff.com

APPLY FOR THIS JOB

Contact Person: Maria Pell

Email Address: mp@hechkoff.com

Apply URL: https://careers-prothena.icims.com/jobs/1030/head-...

Head of Communications

Job ID: 23321319

Position Title: Head of Communications

Company Name:

Prothena

Industry: Biotechnology

Job Function: Communications

Entry Level: No

Location(s): South San Francisco, California, 94080, United States

Posted: April 16, 2015

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: Over 10 Years

Required Travel: None

APPLY FOR THIS JOB

Contact Person: Maria Pell

Email Address: mp@hechkoff.com

Apply URL: https://careers-prothena.icims.com/jobs/1030/head-...

5/24/2015 33

Save Job Email Job Print Job

Job Description

Responsibilities: The Head of Communications will:

Provide strategic leadership, development, direction and management of all Prothena corporate communications and public relations initiatives, while partnering closely with: the Chief Financial Officer to coordinate investor meetings/communications, and the Head of Clinical Affairs to coordinate scientific communications (publications and scientific conference participation), patient outreach/advocacy and government relations initiatives.

Develop and manage all communications – examples include: internal and external collateral/publications, executive presentations and speechwriting, webcasts, industry and financial press releases, on-line/electronic communications, quarterly earnings announcements, annual report and web content.

Advise and work closely with the CEO, CFO, CSO / Head of R&D – as well as other key corporate and scientific leadership team members – on executive communications/presentations to ensure clear consistent messages are being delivered to the internal (employees, board, etc.) and external (investors, patients, KOLs, etc.) audiences.

Communicate Prothena’s primary objectives, strategies, pipelines, operations and financials, as well as be the primary liaison and contact person for the media and investment community.

Coordinate meetings on behalf of leadership/management with new and existing investors, research analysts, investment banks, and media.

Build and maintain relationships with the various stakeholders that influence the Company’s success – including the investor, research analyst, investment banks and media, patient advocacy and

government affairs.

Job Requirements

Qualifications: Ideal candidate will have a minimum of 10-15 years of investor and corporate communications experience

in a corporate or agency setting with responsibility for the strategic direction of such programs. Biotechnology/biopharmaceutical, pharmaceutical, life sciences or related industry as well as previous experience communicating similar business models to external audiences is required. In addition, the successful candidate:

Must have demonstrated leadership skills and a successful track record with establishing relationships within a company and with investment banks, research analysts and the investor communities.

Must be results oriented with tenacity to drive efforts from concept to development to

implementation. High energy, adaptability and integrity. Self-starter with high standards of performance.

Must have strong strategic thinking skills and the ability to develop and execute investor and corporate communications programs.

Must be able to budget and manage internal/external resources. Must have exceptional communication, presentation and interpersonal skills with all levels in the

organization. Must be a strong manager and proven leader who works with the highest level of ethical and

professional values in a matrixed environment. Must be able to partner with the Chief Accounting Officer and Head of Finance in managing the

Company’s financial communications, including quarterly earnings preparation and scripts, media outreach, annual report, and leadership content for investor presentations.

Should have financial and analytical skills with demonstrated ability to interpret information for the

investment community and senior management. Must possess excellent oral and written communications skills and have the ability to work

independently in a fast-paced and fast-tracked environment. Ability to translate scientific concepts into language for the lay public.

Candidate should have excellent computer-based skills and presentation skills. Candidate should be able to manage agencies, vendors and budgets for delivery of on-time and on-

budget deliverables.

5/24/2015 34

Must be an analytical thinker and decision maker, especially on complex issues, as well as problem solver with practical and sensible solutions.

Preferred Education, Experience and Skills Must have BA/BS. Marketing, Communications, Journalism, Business Administration or related area

(Science degree a plus); MBA a plus. Traditional and Social media experience.

Personal Competencies Candidate will possess maturity, experience and help shape, build, maintain and protect the

Company’s image and reputation and provide its leaders with confidence in his/her abilities and business judgment.

Candidate will act with urgency in order to achieve results while maintaining high quality standards and attention to detail.

Candidate should possess an entrepreneurial mindset, but understands the importance of and acts with discipline. Candidate must remain calm under pressure and tight timelines; candidate is responsive to the needs of all stakeholders, as well as takes initiative to drive results, and exercises excellent judgment.

Candidate should be able to prioritize multiple expectations based on the Company’s strategy and goals, providing focus for and setting expectations with internal business partners.

Candidate will tackle role with passion, commitment, enthusiasm and a can-do attitude. Candidate must work well in a team environment to influence common goals to ensure an

integrated approach in pursuit of business goals, and will take on additional responsibilities/special projects, as needed.

Candidate will have the ability to perform at a high professional level with a high degree of independence.

Prothena is partnering with Maria Pell, Managing Director/Hechkoff Executive Search Inc. For immediate consideration please forward your resume and cover letter to: Maria Pell Managing Director

Hechkoff Executive Search Inc. *******************************************************************************

APPLY FOR THIS JOB

Apply URL: http://www.amgen.com/careers

Senior Counsel Patent Biology

Job ID: 23342105

Position Title: Senior Counsel Patent Biology

Company Name: Amgen

Industry: Biotechnology

Job Function: Legal Affairs

Location(s): Thousand Oaks, California, 91358, United States

Posted: April 17, 2015

Entry Level: No

Job Type: Full-Time

Job Duration: Indefinite

Min Experience: 3-5 Years

Email Job Print Job

Job Description

The Senior Counsel will be involved in patent application drafting and prosecution, research and licensing agreements, legal opinions and strategies, trademark and copyright matters, and potentially patent litigation support.

This person will be responsible for identifying patentable subject matter; drafting, filing and prosecuting patent applications; developing legal strategies relating to products and product candidates; analyzing patents and preparing infringement, validity and freedom-to-operate opinions; conducting due diligence in

support of licensing activities; negotiating and drafting research agreements; and providing advice and counsel to R&D and business personnel on a variety of IP related matters. The Senior Counsel will work individually and in legal teams and cross-functional R&D and business

5/24/2015 35

teams. The position may be based at Amgen’s South San Francisco, CA site or at Amgen’s Thousand Oaks, CA site. Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status. To learn more about this position and to apply online, please visit www.amgen.com/careers (search under Job Number 31093BR).

Job Requirements

Basic Qualifications:

JD degree from an accredited law school and admission to practice law required & 4 Years of experience practicing patent or intellectual property law Preferred Qualifications: - 10 plus years of experience practicing patent or intellectual property law

- Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation. - An advanced degree or experience in biology - Excellent analytic, legal drafting and oral and written communication skills.

- Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams; ability to work efficiently, to prioritize workflow, to meet demanding deadlines, and to manage multi-dimensional projects in a fast-paced environment.******************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=ED2ECBE2-B8A0-4303-8405-0ED74DB32E86&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06&industryid=F874EF19-DAEB-4522-9498-02D50BEC5D3F

Job Summary Date Posted: 4/22/15 Location:

Santa Clara, CA Salary Range: Open Project Manager RA - 15000003MD

Abbott Job Description Primary Job Function:

As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Supervisory / Management Responsibilities: Individual provides leadership without direct authority (i.e., project leader). Individual may provide

5/24/2015 36

direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: · Develops, communicates, and builds consensus for operating goals that are in alignment with the

division. · Provides leadership by communicating and providing guidance towards achieving department objectives.

· Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. · May lead a cross-functional or cross-divisional project team.

· Provides technical leadership to business units. · Acts as a mentor to less-experienced staff.

· Exercises judgment independently. Planning/Organization:

· Creates immediate to long-range plans to carry out objectives established by top management. · Forecasts project related needs including human and material resources and capital expenditures.

Decision Making/Impact: · Assignments are expressed in the form of objectives

· Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and

modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education:

Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Minimum Experience / Training Required: 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience

5/24/2015 37

in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. ********************************************************************************** Candidates can send a resume to Angie.Brunet@carefusion.com or apply online: Job Summary Date Posted: 4/21/15 Location: Palm Springs, CA Years Experience: 10+

This Job appears in AdvaMed SmartBrief

Director, Site Quality Management CareFusion

Job Description Life-changers work here CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to

their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical challenges.

Meet one of our Life-changers. http://www.youtube.com/carefusion Job Title: Director, Site Quality Management https://cfn.taleo.net/careersection/2/jobdetail.ftl?job=150500B2&lang=en&sns_id=mailto

CareFusion Business Description At CareFusion (NYSE: CFN), we are united in our vision to improve the safety and lower the cost of healthcare for generations to come. Our 14,000 worldwide employees are passionate about healthcare and helping those that deliver it - from the hospital pharmacy to the nursing floor, the operating room to

the patient bedside. Our clinically proven product families include Pyxis® for medication and supply dispensing, Alaris® for infusion, AVEA® ventilators, Jaeger® for respiratory diagnostic instruments, AVAmax® and PleurX® for

interventional procedures, V. Mueller® and Snowden-Pencer® surgical instruments, and ChloraPrep® skin antiseptic. To make global healthcare better, we partner with our customers to help them improve medication

management, lower costs in procedural areas, reduce risk of infection, advance the care of ventilated patients and turn the endless amount of data generated in healthcare into actionable information. Learn more at www.carefusion.com

Accountabilities The Director, Quality Management (Palm Springs, CA - relocation assistance is available) is responsible for providing tactical direction and management of quality and compliance activities, global supplier management, manufacturing, distribution and materials quality. This includes ensuring that products,

processes and materials meet specified requirements, verifications, validations and other documentation that supports DHF, DMR and DHR. Responsible for ensuring that all aspects of quality systems including design, production, and post market surveillance by working with functional leaders in a matrix

5/24/2015 38

organization. The scope of responsibility spans material quality at source suppliers and continues through the full product life cycle. In addition, the Director, Quality Management will be accountable for the following:

Expected to help define/establish department and policy, participate in all planning activities, lead his/her department and set an example as a leader in the business

Designs, implements, and maintains quality systems which comply with Company Policies, CFR Title 21 Part 820, ISO 13485, Health Canada Medical Devices Regulation and Medical Device Directive 93/42/EEC.

As the designated management quality system representative, recommends/makes quality system changes where needed to measurably improve quality/customer satisfaction

Provides direction and leadership to the business unit management regarding significant product and service quality decisions. Provides quality trend information to aid in achieving those objectives.

Provides direction and leadership including change management to plant quality assurance managers in order to maintain and improve quality operations within the plant.

Primary liaison with FDA and international regulatory authorities for quality system compliance audits and all product actions

Provides active leadership in application of lean six sigma tools and methodologies to improve plant compliance, product quality, and cycle time in quality performance.

Liaise between the business unit, manufacturing, sourcing, R&D, regulatory affairs, customer advocacy and corporate quality on quality matters.

Initiate and direct corrective actions related to product or process quality, including redesigns for complaint resolution, exception management, and field corrective actions.

Ensures integrity of Product and Process Risk Management Responsible for Incoming material inspection process Responsible for distribution quality Provide leadership and direction to site QA management in order to continuously improve product

and process quality and regulatory compliance Provides periodic detailed status reports to management demonstrating performance to

department objectives, capital and expense budget and employee development initiatives. Recruit, retain, train, develop, manage and lead quality talent Manage departmental spending to the established budget(s) and lead departmental financial

initiatives to effectively utilize allocated resources Creates systems and processes that support innovation; challenge "traditional ways", invent/apply

"new ways", emphasizing and demonstrating operational excellence, while understanding the impact of change on the team and developing strategies to ensure continued team success

Creates relationship internally and externally to reach consensus on complex strategic issues, leveraging cultural and individual differences among parties to maximize success and drives team through ambiguity; champions team decisions

Job Family Summary

QRA Management is responsible for strategic oversight and leadership direction within the QRA function. Qualifications

A technical Bachelor's degree in engineering, physical science or a clinical field required, advanced

degree preferred 10 years of experience in a Quality role within a FDA regulated environment Manufacturing Quality leadership experience required 5 years of direct management experience required

Strong leadership, communication, and collaboration skills required Ability to convey complex ideas, impressions, and information to negotiate an outcome or influence

events Inspirational leader Strategic thinking and managerial courage required

Customer and patient focused individual Application of Lean Six Sigma to manufacturing processes required LSS Black Belt Certification is highly desired

5/24/2015 39

ASQ certifications in quality management, quality/reliability engineering, and/or quality auditing are highly desired

CareFusion is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law. ***************************************************************************************

Sr Regulatory Analyst

The Genetic Systems Division of Thermo Fisher Scientific is seeking an experienced Senior Regulatory Analyst. The successful candidate will be responsible

for providing Regulatory Affairs support...

Thermo Fisher Scientific

S. San Francisco

05-10 Years

04/23/15 Active

Regulatory Analyst

The Regulatory Analyst will be responsible for preparing U.S. 510(k) regulatory submissions, preparation/maintenance of Technical Files for European CE-IVD products, preparation/renewal of CMDL...

Thermofisher Scientific

Pleasanton, CA

01-05 Years

04/23/15 Active

Engineer Opportunities in San Jose include Director of ME, ME,

EE, QE, Biochemist, Physiologist and so on. Details will be posted soon at...

Winning Difference

United States

00-01 Years

04/20/15 Active

********************************************************************************* https://jobs.smartbrief.com/action/listing?listingid=ED2ECBE2-B8A0-4303-8405-0ED74DB32E86&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/22/15 Location: Santa Clara, CA

Salary Range: Open Project Manager RA - 15000003MD Abbott

Job Description Primary Job Function: As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge

of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities:

5/24/2015 40

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Supervisory / Management Responsibilities: Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction

and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.

Influence/Leadership: · Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

· Provides leadership by communicating and providing guidance towards achieving department objectives. · Interfaces with a variety of management levels on significant matters, often requiring the coordination of

activity across organizational units. · May lead a cross-functional or cross-divisional project team. · Provides technical leadership to business units.

· Acts as a mentor to less-experienced staff. · Exercises judgment independently.

Planning/Organization: · Creates immediate to long-range plans to carry out objectives established by top management.

· Forecasts project related needs including human and material resources and capital expenditures. Decision Making/Impact:

· Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the

program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

Minimum Education: Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology,

5/24/2015 41

immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Minimum Experience / Training Required: 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. .

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

Other Information for Those in Transition ************************************************************************* ***********************************************************************

32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32-biotech-and-biopharma-recruiters/77900088/?page=1 ************************************************************************

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 See most recent Beyond borders: unlocking value Global biotechnology report 2014 At http://www.ey.com/GL/en/Industries/Life-Sciences/EY-beyond-borders-unlocking-value *************************************************************** 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

5/24/2015 42

UC Davis Internship and Career Center Guide to Resumes (2011) Download at http://iccweb.ucdavis.edu/pdf/crm/0910/crm-resumes.pdf _____________________________________________________________ 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

5/24/2015 43

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. 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

5/24/2015 44

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 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

5/24/2015 45

Luke Timmerman’s blog on Xconomy. ********************************************************************* 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 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/38033/title/2013-Life-Sciences-Salary-Survey/

5/24/2015 46

Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies. The fifteenth survey is available at http://www.contractpharma.com/contents/view_salary-survey/2014-06-05/2014-fifteenth-annual-salary-and-job-satisfaction-/ The most recent salary survey in medtech is “Medtech Salary Survey 2013: A Sneak Peek” by Jamie Hartford, posted in Medical Device Business, Nov. 5, 2013. See snapshot at http://www.mddionline.com/article/medtech-salary-survey-2013-sneak-peek See additional comments in report dated Nov. 27, 2013. This year’s annual Medical, Marketing and Media salary survey was released in October 2014. The article entitled “Career and Salary Survey: In Check,” Oct. 2014 is found at http://editiondigital.net/publication/frame.php?i=226938&p=&pn=&ver=flex You can download the Premium Edition in pdf at http://media.mmm-online.com/documents/93/css_2014_premium_edition_23196.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. *************************************************************************