1/18/2015 1

Jobs That Crossed My Desk Through Jan. 18, 2015 Complimentary Service of Audreysnetwork.com

Jan. 18, 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. *********************************************************************

Contact Name:

Chris Eck

Contact Phone:

847-887-3914

Contact Email:

chris.eck@cardinalhealth.com

Website:

http://cardinalhealth.com

Regulatory Affairs Manager Accountabilities in this role SUMMARY: Manage day to day activities for Regulatory Affairs department. Work closely and partner with internal departments to efficiently deliver accurate,...

Cardinal Health

Santa Clara

10-15 Years

01/15/15 Active

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

Contact Name:

Carolina Barreto

Contact Phone:

209-390-1474

Contact Email:

carolina@balancestaffing.com

Senior Quality Engineer Exciting career opportunity for an experience Senior Quality Engineer to join a well-established and reputable medical manufacturing company in the Stockton, CA area. The Senior Quality Engineer...

Balance Staffing

Stockton 05-10 Years

01/08/15 Active

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

1/18/2015 2

Posted by Darshana V. Nadkarni, Ph.D. on January 17, 2015 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. Engineers conferring on prototype design, 1954 (Photo credit: Wikipedia)

__________________________________________________________ QUALITY ENGINEER – Santa Cruz, CA Summary: Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer. Position focus is on

providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products. Responsibilities

* Write FMEAs, review and write protocols and reports for new products * Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes. * Responsible for the facility measurement equipment calibration and maintenance program.

* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends. * Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve

measured improvement. * Implements the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action. * Support Receiving, In- process and Final Inspection of various components and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.

* Assist in the development and implementation of Quality System processes. * Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team goals including; QSR and ISO compliance, revenues, training utilization,

customer satisfaction, and others as appropriate. * Qualify and implement document changes involving product or process changes * Coordinate the reporting, analysis, and resolution of material non-conformance incidences * Provide support in the timely resolution of product complaints and/or safety issues

* Conduct quality audits and develop subsequent preventive action programs * Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies. * Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non-compliance and ensure timely/effective corrections and lor corrective preventative actions are implemented

* Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests. * Report MRB performance metrics and maintain corrective action database.

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* Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions Requirements: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence. Electro-Mechanical Technician – Fremont, CA A company that develops advanced injection technologies to simplify the complexities of the cardiac cath lab, has an immediate opening for R&D technician. Requirements

* 9 years of electromechanical technician experience * 2 year Technical School degree in electromechanics or related field or a combination of education and experience * 2 years of computer aided design experience

* 2 years experience directing and leading the work of others * Problem solving skills with the ability to interpret drawings, schematics, and specifications * Experience using CAD-3D Modeling * Effective verbal and written communication skills

* Moderate level of computer experience including MS Office Suite and SolidWorks * Demonstrated experience using a multimeter, soldering iron, oscilloscope, and spectrum analyzer * High degree of organization skills and high attention to detail * Ability to prioritize and handle multiple tasks

* Ability to work independently with limited supervision * Proficient at specifying and evaluating electrical components based on performance, lifetime, and availability * Demonstrated project management experience * Demonstrated test report-writing experience

Preferred: 4+ years of computer aided design experience, * SolidWorks Proficient, * Experience providing technical support to circuit board manufacturing assembly, * Demonstrated knowledge of and familiarity with embedded systems and RF electronics, * Product development experience in a federally regulated engineering environment (FDA, ISO), * Experience defining, writing, and conducting test plans and

reports. Job Description & Responsibilities Performs specified electromechanical engineering support activities under the guidance of an Engineer or Technical lead related to electro-mechanical design of medical device technologies, product and

performance testing, and continuous improvement of the product design. The position is responsible for design, fabrications, assembly, validation, and implementation of development products and fixtures to support the design transfer of products into manufacturing operations. Primary Duties and Responsibilities:

* Designs fixtures and test methods for validating product design and performance. Responsible for managing the ordering and delivery of fixture components and items from vendors or the internal Model Shop. * Executes testing and validation protocols, records and analyzes data, and provides written reports to

engineering team. * Supports Product Development efforts at early stages up to design transfer. Provides support to engineers throughout the implementation and development cycles. * Performs hands on activities such as design validation, pre-production assembly, testing and other technical activities to assist in product development.

* Assists engineers in identifying and resolving hardware design issues. Diagnoses the cause of electrical failures of circuit boards and operational equipment. * Uses Solid Works CAD system to sketch and design fixtures and devices ensuring form, fit and functional requirements are met. Responsible for basic analysis of design in partnership with an Engineer.

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* Responsible for initiating documentation changes and providing redlines to maintain the product information structure. Communicates issues and opportunities to engineering department to ensure bill of material (BOM’s), prints, process, forms, records, etc. are relevant and up to date. Technical Engineering Support: * Partners with Designers and Engineer, to develop and improve products, designs, fixtures, and process activities in the interest of continuous improvement and establishment of a Lean environment. * Initiates design changes and coordinates the change order process to release product per the company’s Quality Management system. Responsible to maintain the design and information structure for use in the ERP system and engineering data base (PDM) DB Works. e.g.; BOM’s, prints, process, forms, records etc. * Implements changes and maintenance of PDM and CAD systems as required. Assists IT and Technical Documentation Writer in annual CAD system updates, user rights management, and data base management. Creates and edits DB-Works and Solid Works API programs. If interested in this opportunity then please submit resume with answers to the questions below – that is client requirement. Describe your formal education: Describe your experience working in medical device or a regulated environment.

Give an example of a work situation where you had minimal supervision and it was critical to work within a fluid or flexible environment. Describe your experience with developing test fixtures and methods to evaluate a product and/or technology.

Describe your experience developing or using different types of CAD models (or Computer-Aided Design), electrical schematics, or other types of models. (New Q) Give an example of a product and/or technology project where you had to apply both mechanical and electrical/electronic skills.

See link http://bit.ly/15STeDw to my earlier blog on details to the three opportunities below. Director of Analytical R&D for biologics company in China Director of Patent Portfolio Management – China

Director of QA – China Details for below positions coming soon……..please check back Senior Neuro Scientist – New York CFO – MA Entry level Engineers for medical device company – MA

Several opportunities in San Jose, CA ****************************************************************

Job Summary Date Posted: 1/8/15 Location:

Irvine, CA Global Medical Safety Director - Transcatheter Heart Valve Edwards Lifesciences Job Description

The Safety Director leads the safety assessment of the full portfolio of THV products in clinical evaluation in USA and Europe.

In this position you will develop safety strategy for the THV products in clinical studies including overview of safety assessments, identifying/analyzing safety signals and trends, creating and

implementing safety processes and training's and providing clinical safety expertise support for other departments.

Supervise safety medical officers in carrying out safety data review and analysis and providing safety input on key regulatory or clinical documents (CSRs, protocols, etc.).

Develops Clinical Events Committee (CEC) adjudication process and provides ongoing oversight of

the workflow between CEC and Edwards as well as between Edwards and all clinical sites. Responsibilities:

Development and implementation of global THV Safety processes according to regulatory requirements, Edwards SOPs and ethical obligation

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Ongoing oversight of adverse event reporting, review and timely adjudication for THV clinical studies

Ensure appropriate oversight of the safety profile of the THV product in clinical evaluation, including review of individual safety cases and aggregate reports, signal detection and evaluation, and escalated safety issues appropriately within the company

Assessment of adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested)

Cross-function cooperation with Clinical Affairs, Regulatory Affairs, Quality, R&D and Marketing regarding all aspects of safety assessment of the THV Products in clinical studies and post-market registries

Contribute to Safety protocol design, submissions, reports, clinical summaries, updates and other Represent THV on safety aspects for the product externally, engagement with DSMBs CEC, EC,

preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders

Facilitate talent management activities to include hiring, training, staff development and succession

planning Develop and facilitate safety training to include creation of materials for EW team and sites Establish CEC adjudication process and workflow including CEC charter and workflow between

Edwards and the CEC

Qualifications: M.D. (or equivalent OUS medical degree) is required. At least 5 years of global industry experience with device/drug safety is required or more than 10

years of industry experience with clinical trials.

Knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development is required.

Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is required.

Required Skills: Comprehensive understanding of medical terminology and familiarity with principles of clinical

assessment of ADEs Comprehensive knowledge of medical device regulatory documents/ device accountability/ adverse

events reporting including the US Code of Federal Regulations (CFR) 820, Canadian Medical Device

Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 Ability to communicate and relate well with members of the Clinical Events Committee (CEC) and

members of the Data Safety Monitoring Board (DSMB), study investigators and supporting staff Demonstrable excellent written and verbal communication skills, presentation skills, interpersonal

skills and analytical skills are a must Substantial computer literacy Must have the ability to travel up to 30% of the time, with occasional international travel

********************************************************************** dHealthCareers.com Connect with Cardiology recruiters from the nation’s leading facilities and institutions with

eHealthCareers.com – Elsevier’s robust and easy-to-use medical job board. Below are the latest Cardiology career opportunities. Don't see the position you're looking for? Visit the site to view even more opportunities pulled from over 400 leading medical journals.

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DIRECTOR, ECHOCARDIOGRAPHY Featured

1/18/2015 6

Location: Los Angeles , California 90033 Company: University of Southern California Date: 1/6/2014

Description: The successful candidate will serve as Director of Echocardiography, including the investigational percutaneous valve imaging programs, established core echocardiography laboratory, and...

Pediatric Electrophysiologist Yale-New Haven Children’s Hospital / CT Children’s Medical Center

Featured

Location: New Haven, Connecticut Company: Dr. Hellenbrand – Yale School of Medicine

Date: 12/10/2014 Description: Applications are invited for a Pediatric Electrophysiologist to join an exciting new joint venture in pediatric cardiology between Yale New Haven Children’s Hospital

and Connecticut Children’s’ Hospital. The successful candidate will have expertise...

BC/BE Interventional and Non-Invasive Cardiologists Featured

Location: Ames, Iowa

Company: McFarland Clinic Date: 11/6/2014 Description: McFarland Clinic is seeking BC/BE Interventional and Non-Invasive Cardiologists to join our busy, growing practice

in this Big 12 University city. • Technologically advanced Cath Lab and office suites• EMR• Strong Hospitalist and ER department•...

PEDIATRIC CARDIAC INTENSIVIST Featured

Location: Hollywood, Florida

Company: Joe DiMaggio Children’s Hospital Date: 12/30/2014 Description: About the Opportunity The Heart Center at the Joe DiMaggio Children’s Hospital (JDCH) is recruiting a Pediatric

Cardiac Intensivist to join our rapidly growing cardiac program in South Florida....

Cardiac Intensivists Featured

Location: Florida

Company: Memorial Healthcare System Date: 12/30/2014 Description: About the Opportunity Memorial Healthcare System

1/18/2015 7

is seeking two critical care physicians, dedicated to night shifts, to join the critical care team. Successful candidates will have excellent clinical skills, a broad knowledge base in critical care...

Non-Invasive Electrophysiology Featured

Location: Billings , Montana Company: Billings Clinic Date: 12/10/2014

Description: Practice state-of-the-art medicine in our new 20,000 square foot facility.• Heavy interventional volume, large tertiary referral center• The only certified Chest Pain Center in the region• Full spectrum of cardiac services including EP•

Cutting edge...

Academic Structural Interventional Cardiologist Featured

Location: Boston , Massachusetts Company: Massachusetts General Hospital

Date: 12/29/2014 Description: The Cardiology Division of Massachusetts General Hospital is actively recruiting a faculty member to join the Knight Cardiac Catheterization Laboratory and Interventional Cardiology

Associates. The candidate must be board-certified in internal...

Vascular and Interventional Radiology Physician Location: Toronto , Ontario Company: University Health Network and Mount Sinai Hospital Date: 1/1/2015

Description: The Joint Departments of Medical Imaging of the University Health Network and Mount Sinai Hospital are seeking a Vascular and Interventional Radiology physician to become a member of our faculty. The successful applicant must be Royal

College of... Academic Vascular Surgeon

Location: Los Angeles, California Company: UCLA Vascular Surgery Date: 12/2/2014 Description: Academic Vascular Surgeon The Division of Vascular and Endovascular Surgery in the David Geffen School of Medicine at

the University of California, Los Angeles is seeking a board eligible/certified vascular surgeon for a full time faculty position at...

Heart Failure Cardiologist Location: Vancouver , British Columbia Company: VGH Division of Cardiology Date: 1/1/2015

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Description: UBC Division of Cardiology seeks a cardiologist with clinical and research expertise in Heart Failure and Heart Rhythm Management. This full time Clinician Scientist appointment will be at the rank of Clinical Assistant Professor. Primarily... ****************************************************************** Contact Laurie at ldesio@alexza.com if you are interested. The three jobs below are with Alexza. Alexza Pharmaceuticals, a specialty pharmaceutical company located in Mountain View, California, leads the way in providing non-invasive, novel therapies for the acute treatment of central nervous system conditions. Our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes drugs to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Because of the particle size of the aerosol, the drug is quickly absorbed through the deep lung into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration but with greater ease, patient comfort, and convenience. Our

first product, Staccato loxapine, (known commercially as ADASUVE®) has been approved for marketing in the United States and in the European Union. We also have a pipeline of product candidates based on the Staccatosystem which are in various stages of development in the CNS arena. Alexza Pharmaceuticals is one of many successful companies founded by a leading pioneer and

preeminent entrepreneur of the pharmaceutical and biotechnology industries, Dr. Alejandro Zaffaroni. The legacy of the companies founded by Dr. Zaffaroni has truly left an indelible, positive mark, and a lasting impact on society.

Associate Director / Director, Regulatory CMC In this highly visible and critical role reporting to the Sr. VP of Regulatory Affairs, your leadership skills and expertise will prove invaluable to the continuing success of Alexza. • Provide regulatory guidance on CMC issues over the lifecycle of product development, including post-

approval support. Facilitate creative solutions to address CMC-related challenges. • Serve as Regulatory CMC member on project teams. Lead sub-teams to address CMC issues. Interact with other functional groups (e.g., Analytical Development, Engineering, Manufacturing, and Quality).

• Assess regulatory impact of any proposed changes to product design, manufacturing or testing. • Facilitate and/or author CMC documents for regulatory submission. Ensure that CMC data for regulatory filings are technically sound and appropriately audited. Interact with Regulatory Operations to streamline

process for preparation of submission-ready documentation. • Keep current on regulations, guidances, standards, and industry positions and initiatives pertaining to CMC topics; update the company on current developments.

• Liaise with corporate partners on Regulatory CMC issues. Liaise with suppliers on proposed changes. Proactively assess and provide guidance on regulatory impact of proposed changes.

• Serve as Regulatory member of Change Control Board and Specifications Committee Desired Skills and Experience

Advanced degree in a scientific field required; Ph.D. preferred 6+ years of experience in pharmaceutical product development or equivalent

Expertise in preparing CMC documentation for regulatory submissions. Experience interacting with Regulatory Agencies. Experience with inhalation products or drug-device combination products highly desirable.

Experience with international regulatory submissions desirable Effective regulatory writing and oral communication skills. Ability to make persuasive arguments to

support regulatory position Working knowledge of regulatory requirements for IND, NDA/MAA. Working knowledge of

regulatory requirements to support post-approval changes in US and Europe. Working

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understanding of cGMP and QSR regulations and guidances applicable to the development of combination products.

Leadership and organizational skills to effectively lead sub-team preparing CMC documentation for regulatory submission.

Ability to work in a fast-paced environment We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth. ______________________________________________________________________

Director / Sr. Director, QC Your talents and expertise will be critical in this visible role, partnering with the VP of Quality, and working closely with our QC team to continue manufacture for our first commercial product, while continuing to fill our Research and Development pipeline. Responsibilities:

Provide overall strategic and tactical leadership for the QC laboratory, including hiring/selection,

training and development of qualified staff. This entails developing QC lab goals in support of regulatory submissions, clinical efforts, and commercial product supply and program-driven milestones.

Responsible for departmental GXP compliance and serve as key point between customers, contract

laboratories, auditors and regulatory agencies (FDA/DEA). Support agency inspections; provide lead escort role in all audits involving the QC laboratory and

serve as SME during audits of raw material manufacturers or contract laboratories, followed by writing audit reports.

Oversee QC quality testing method development/validation and USP/EP/JP/BP method verification activities to support development and manufacture of drug/device products. Write, review, author as needed qualification-validation protocols for testing methods, implementing testing procedure, etc.

Manage all phases of equipment and instrumentation lifecycle (qualification, validation, purchase, end of life, maintenance, troubleshooting and calibration).

Identify and implement changes to improve lab compliance, safety, efficiency and long-term sustainability, including capacity planning to anticipate commercial production scaleup and daily laboratory resources.

Develop and sustain laboratory reference standard program, partnering with contract laboratories to ensure the same as appropriate

Manage all phases of the Stability program, including protocols, etc. and responsible for all phases of investigations, communication and resolution into failures, deviations and aberrant results

Responsible for analytical aerosol testing (primary techniques are GC-FID, GC-MS, HPLC-UV, HPLC-MS, UV-vis, FTIR).

Transfer of QC methods from other laboratories to Alexza or from Alexza to other laboratories as needed to support development projects and marketed products.

Coordinate the microbiology program, including release testing of raw materials and products, while monitoring the water system and production environment

Performs other related duties as required

Skills and Experience: B.S. in Biology/Biochemistry/Biotechnology/Chemistry/Microbiology or related field required. Ph.D.

preferred. 11+ years related experience, including leadership of QC and other technical staff

Must have demonstrated experience in forced and accelerated stability, FUST, stress conditions and harmonized requirements

Experience writing applicable sections of regulatory filings, i.e. authoring regulatory submissions of CMC sections with strong knowledge of GXP compliance

Demonstrated technical project management experience, including technical report writing

Demonstrated track record of excellent laboratory leadership (GXP, safety, quality) including cross-functional team interaction

Outstanding analytical and problem solving abilities Good working knowledge of USP, EP, ICH and FDA guidelines

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Expertise in developing and setting product specifications Knowledge of relevant compendia, chemical/microbial/biological assays and general lab equipment

________________________________________________________________________________ Sr. Process Development Engineer As a key member of our engineering team, your expertise and talent will be needed to: • Design and develop processes for manufacturing drug/device products using statistics based experimentation and principles of design for manufacturability • Lead process improvement efforts using lean/six sigma methodologies to drive manufacturing efficiencies in a cGMP environment. • Troubleshoot and maintain production equipment • Write manufacturing and standard operating procedures and methods • Conduct product and process investigations in cGMP environment; summarize results in a presentable report format. • Work with in-house groups such as QA validation and vendors to ensure regulatory and company compliance of manufacturing processes. • Monitor (e.g. SPC and OEE) the performance of processes and equipment and make recommendations

for continuous improvement • Work with the in-house teams to introduce new process equipment through appropriate validation and GMP documentation (e.g. GAMP) Desired Skills and Experience

• Good understanding of manufacturing processes – hands-on experience with automated manufacturing process equipment (e.g., medical device assembly, packaging, fill/finish). Knowledge of PLC programming and associated controls is highly desirable. • Good understanding and use of statistical methods in experiment design and data analysis. Experience

in setting process and product specifications. • Excellent interpersonal skills to allow effective participation in project teams. • Self-motivated person with initiative to complete tasks independently. Must be able to work in a dynamic, multi-tasking and cross-functional environment

• Solid oral and written communication skills. • Able to analyze complex problems and develop solutions or approaches to resolve issues. • Prior experience with Pharmaceutical / Medical Device process development a plus. • Experience with process improvement projects using industry standard methodologies such as lean/six sigma is highly desirable

Education and Experience: • B.S. in Chemical Engineering with, 8+ years experience in manufacturing engineering / process development environment. An advanced degree in a related field may be considered as substitute for one

or more years of experience. • Prior experience in a dynamic, fast paced start-up environment would be valuable We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment, and excellent opportunity for career growth.

***************************************************************************** jobs@cirm.ca.gov or CIRM Search, 210 King Street San Francisco, CA 94107. Electronic applications preferred.

Job ID: 21733933

Position Title: Director

Company Name:

California Institute for Regenerative Medicine

Industry: Biotechnology

Job Function: Program Director

Entry Level: No

Location(s): San Francisco, California, 94107, United

Posted: January 7, 2015

Job Type: Full-Time

Job Duration: Indefinite

Min Education:

Ph.D.

Min Experience:

Over 10 Years

Required Travel:

10-25%

1/18/2015 11

States

Salary: $162,877.00 - $244,204.00 (Yearly Salary)

APPLY FOR THIS JOB

Contact Person: Alexandra Campe Degg Phone: 415 396-9133

Email Address: acampe@cirm.ca.gov

Apply URL: http://www.cirm.ca.gov/about-cirm/jobs-and-rfps

Save Job Email Job Print Job Apply For Job

Job Description

Director, Blood and Cancer Therapeutic Area, Director of Organ Systems Therapeutic Area and Director of Neuro/Ocular Therapeutic Area Who We Are

The California Institute for Regenerative Medicine (CIRM) is looking for highly talented individuals who are driven to deliver outstanding results and committed to radically improving medicine with stem cells to join our team. At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs and act with a sense of urgency commensurate with that

mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell technologies.

With $3 billion in funding and approximately 300 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. Position Descriptions

The mission of the Blood and Cancer Therapeutic Area is to attract and advance the most promising stem cell based technologies for cancer and blood-related conditions. The Blood and Cancer Therapeutic Area currently has over 20 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials.

The mission of the Organ Systems Therapeutic Area is to attract and advance the most promising stem cell based technologies for cardiovascular, lung, liver and other organ system-related conditions. The Organ Systems Therapeutic Area currently has over 25 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials.

The mission of the Neuro/Ocular Therapeutic Area is to attract and advance the most promising stem cell based technologies for neurological and ocular conditions. The Neuro/Ocular Therapeutic Area currently has over 25 active programs and a budget of over $200 million. Projects in the therapeutic area range from translational research through human clinical trials. The Director positions report directly to the President and CEO of CIRM and will have overall responsibility

for leading a cross-functional team of scientists and project managers to develop and advance CIRM’s portfolio of promising therapies in the blood and cancer fields.

Job Requirements

The successful candidate will be a strong leader of people with an innate sense of urgency, who delivers outstanding results and inspires the team to find new and innovative ways of meaningfully advancing CIRM’s mission. Please see our individual Director job postings with requirements on CIRM’s website at http://www.cirm.ca.gov/about-cirm/jobs-and-rfps

Position Details Location: San Francisco, CA Schedule: Full-Time. Must be able to work outside of normal business hours. Travel: Must be able to travel domestically and internationally as necessary.

Salary Range and Benefits The salary range for this position is $162,877-$244,204. CIRM offers a competitive compensation package. The position is open until a suitable candidate is found. How to apply

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Interested candidates please submit: •Cover letter •CV/Resume ******************************************************************* http://www.indeed.com/viewjob?jk=5e14685bcc92bcb7&from=api&q=(%22medical+device%22)+$80,000%2B&atk=19b69dcfe19rh1fn&sclk=1&sjdu=WnCNESGvMkQ1jqfT4QdUyNFUnGvIlgqUKs29VxO3zWBQWK8SLUDLjtCEX1R4bOxJ3Ae7panME7upEj7QFinDziuVXmVwFS4O8QdahllfGzUdHfw7YwF8BL7Q53E0vtSYtOWHOoazdvMKb6Xtejch4oGaLfO14DIUnabjpe3S_PEQcc_mIjPprvnEdTo4GBCASVRV-RijRioZRxnV-FWpWEwlBElmRsW61lRsgG1Uyw-2f5PvBaQjsjLtRTfZy3WmcdnQVNxsFpFOkY3wAYUR8ZdTftdDXGV9w_ZehWu2ecc&pub=968861454902829 Senior Regulatory and Product Compliance Specialist Thermo Fisher Scientific - Fair Lawn, NJ

Expertise Quality Assurance Job Type

Full-time Location United States - New Jersey - Fair Lawn

Job Level Manager Posting date: July 10, 2014

Position Summary: Lead and perform regulatory and compliance activities for the company’s regulated products (Multi compendia Production chemicals, cGMP products and medical device products) as directed with primary responsibility for USFDA and Secondary responsibilities for MHRA, TGA, SFDA. Provide International (outside North America) regulatory submission support. Coordinate

with International regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate and Business Unit standards. Provide direction to cross functional project teams as necessary for compliance to internal and external standards as required. Provide regulatory interface during the product commercialization process and throughout the entire

product life cycle including post-market surveillance. Provide compliance support for various product and process related activities Minimum Requirements/Qualifications:

Define regulatory requirements necessary for class 1 device products, cGMP and production chemicals in North America. Complete North American regulatory assessments as required to support projects and provide direction to project teams to support new product development and product modifications as required.

Provide direction on application of external standards for all projects as required. Execute US and International product submission strategies as directed. Maintain all regulatory documentation to ensure availability for audits and preparation of PTFs in North America.

Assist in completing international regulatory assessments as required to support new product

development and product modifications. Position may execute international PTFs as directed. Lead regulatory activities for product field corrective actions, post market activities to maintain

compliance and ensure that product approvals are properly maintained and product warranty claims are properly managed.

Coordinates timely renewal of certificates, licenses, and registrations.

Assist in creation and approval of product labeling and instructions for use , review and approve marketing literature and other items for compliance with relevant regulatory requirements.

Assist in the development and implementation of the existing and all new acts (e;g: Sunshine

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Act, Med Device Tax Act etc) Review Engineering Change Requests (ECRs) for global regulatory impact. Author, review, and/or approve internal operating procedures related to regulatory affairs. Author and maintain all Product Technical Files and Label controls for Class 1 and Class 2

devices Review and submit necessary changes to existing registered products with US FDA Coordinate all activities with Internal Thermo Fisher Partners and Outside vendors for

implementation of necessary controls for Medical Device Products Coordinate with QA, Engineering, Sourcing and Operational teams to ensure all necessary

regulatory activities related to their areas of operations are well implemented. Effectively manage Product Management Change Requests to comply with MOC process Implement and monitor CAPA activities internally and externally. Escalate process failures to

Global Director of Quality. Represent Quality and Regulatory functions during customer and agency audits Skilled with internal customers; ensures frequent stakeholder communications for input and

alignment; well-honed “radar” for situations requiring stakeholder management.

Strong communication skills, including written, verbal and presentation skills; credible with internal stakeholders and external audiences.

A flexible, dynamic, self demanding and proactive individual; able to motivate themselves, suppliers, cross functional team members and others.

Education and Work Experience:

Bachelors degree in Science or Engineering o Minimum of 5 years of experience in Regulatory Affairs and Compliance

Minimum of 3 years medical device industry experience including US and International market submissions.

Strong working knowledge and experience with quality systems regulations and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive

(MDD), ICH Q7, Canadian Medical Device Regulations (CMDR), IVDD, SFDA, TGA and US FDA regulatory requirements.

Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.

Demonstrated ability in project management skills in order to plan, conduct and

implement system assessments and robust submissions. Skill in determining alternatives that would correct a situation to comply with

standards and regulations Strong experience in Technical writing, design controls, Risk analysis and

management of Medical Device Products. Must have ability to manage complex product line Must have lead or managed regulatory or compliance teams for at least 2 years

in Class 1 and 2 device manufacturing companies before.

Preferred Certifications : RAC Certification from RAPS or any other recognized Institutes

The above statements are intended to describe the general nature and level of the work being

performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it. This position has been approved for relocation assistance.

****************************************************************** http://www.indeed.com/viewjob?jk=b6d27faa7f1df61e&from=api&q=(%22medical+device%22)+$80,000

%2B&atk=19b69a8vq19ui253&sclk=1&sjdu=5pMl8lli1VeBW3VeUzS-uHSGXxGMVpg4XQ4ZWjFIW-Uqy0Vz6-kifFYzAeuzikPfR-GlBqbgeVhC9YUQ8Ocui3UYxobv_1d7UUrfy3GnKM5oAIA72gq545Czfa2WJ17O-gl_RR8Hj-VnE8NpxR6HAH_IJnUDy-OtPDBIRQs8zKA&pub=968861454902829

1/18/2015 14

Sr. Process Development Engineer Alexza Pharmaceuticals - Mountain View, CA Alexza Pharmaceuticals is a specialty pharmaceutical company located in Mountain View, California, focused on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Our product candidates are based on our proprietary technology, the Staccato® system. The Staccato system vaporizes an excipient-free drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery. Our first product, Staccato loxapine, (known commercially as ADASUVE®) has been approved for marketing in the United States by the U.S. Food and Drug Administration and in the European Union by the European Commission. We also have a pipeline of product candidates based on the Staccato system which are in various stages of development for acute and intermittent conditions, for which we believe the Staccato platform is particularly applicable. Responsibilities: • Design and develop processes for manufacturing drug/device products using statistics based experimentation and principles of design for manufacturability

• Lead process improvement efforts using lean/six sigma methodologies to drive manufacturing efficiencies in a cGMP environment. • Troubleshoot and maintain production equipment • Write manufacturing and standard operating procedures and methods

• Conduct product and process investigations in cGMP environment; summarize results in a presentable report format. • Work with in-house groups such as QA validation and vendors to ensure regulatory and company compliance of manufacturing processes.

• Monitor (e.g. SPC and OEE) the performance of processes and equipment and make recommendations for continuous improvement • Work with the in-house teams to introduce new process equipment thru appropriate validation and GMP documentation (e.g. GAMP 5)

Skills Required: • Good understanding of manufacturing processes – hands-on experience with automated manufacturing process equipment (e.g., medical device assembly, packaging, fill/finish). Knowledge of PLC programming and associated controls is highly desirable. • Good understanding and use of statistical methods in experiment design and data analysis.

Experience in setting process and product specifications. • Excellent interpersonal skills to allow effective participation in project teams. • Self-motivated person with initiative to complete tasks independently. Must be able to work in a dynamic, multi-tasking and cross-functional environment

• Solid oral and written communication skills. • Able to analyze complex problems and develop solutions or approaches to resolve issues. • Prior experience with Pharmaceutical / Medical Device process development a plus. • Experience with process improvement projects using industry standard methodologies such as

lean/six sigma is highly desirable Education and Experience: • B.S. in Mechanical, Chemical, Electrical, or Materials Engineering with, 8+ years experience in manufacturing engineering / process development environment. An advanced degree in a related

filed may be considered as substitute for one or more years of experience. • Prior experience in a dynamic, fast paced start-up environment would be valuable We offer competitive compensation and benefits including stock options, an exciting and collaborative work environment and excellent opportunity for career growth.

Direct Applicants only - NO AGENCIES, PLEASE. Alexza Pharmaceuticals - 30+ days ago - save job *************************************************************** https://jobs.smartbrief.com/action/listing?listingid=AE02EDE6-2840-4A9F-BEA1-

9A285BAD57DE&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06 Job Summary Date Posted:

1/18/2015 15

1/8/15 Location: Irvine, CA Global Medical Safety Director - Transcatheter Heart Valve Edwards Lifesciences Job Description

The Safety Director leads the safety assessment of the full portfolio of THV products in clinical evaluation in USA and Europe.

In this position you will develop safety strategy for the THV products in clinical studies including overview of safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and training's and providing clinical safety expertise support for other departments.

Supervise safety medical officers in carrying out safety data review and analysis and providing safety input on key regulatory or clinical documents (CSRs, protocols, etc.).

Develops Clinical Events Committee (CEC) adjudication process and provides ongoing oversight of the workflow between CEC and Edwards as well as between Edwards and all clinical sites.

Responsibilities: Development and implementation of global THV Safety processes according to regulatory

requirements, Edwards SOPs and ethical obligation Ongoing oversight of adverse event reporting, review and timely adjudication for THV clinical

studies Ensure appropriate oversight of the safety profile of the THV product in clinical evaluation,

including review of individual safety cases and aggregate reports, signal detection and evaluation, and escalated safety issues appropriately within the company

Assessment of adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested)

Cross-function cooperation with Clinical Affairs, Regulatory Affairs, Quality, R&D and Marketing

regarding all aspects of safety assessment of the THV Products in clinical studies and post-market registries

Contribute to Safety protocol design, submissions, reports, clinical summaries, updates and other Represent THV on safety aspects for the product externally, engagement with DSMBs CEC, EC,

preparation for and attendance at regulatory authority meetings, interactions with external

advisers or opinion leaders Facilitate talent management activities to include hiring, training, staff development and succession

planning Develop and facilitate safety training to include creation of materials for EW team and sites

Establish CEC adjudication process and workflow including CEC charter and workflow between Edwards and the CEC

Qualifications: M.D. (or equivalent OUS medical degree) is required.

At least 5 years of global industry experience with device/drug safety is required or more than 10 years of industry experience with clinical trials.

Knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development is required.

Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is required.

Required Skills: Comprehensive understanding of medical terminology and familiarity with principles of clinical

assessment of ADEs Comprehensive knowledge of medical device regulatory documents/ device accountability/ adverse

events reporting including the US Code of Federal Regulations (CFR) 820, Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003

Ability to communicate and relate well with members of the Clinical Events Committee (CEC) and

members of the Data Safety Monitoring Board (DSMB), study investigators and supporting staff Demonstrable excellent written and verbal communication skills, presentation skills, interpersonal

skills and analytical skills are a must Substantial computer literacy

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Must have the ability to travel up to 30% of the time, with occasional international travel ****************************************************************************** CEO, Los Angeles I am a recruiter here at CyberCoders who specializes in placing CEO candidates as well as similar positions in Los Angeles, CA and other locations nationwide. I am emailing you in case you think you would be a great fit for the position listed below. Please check out the link and apply if you are interested in hearing more about the job. :) Also - If you refer a friend I end up placing at any of my open jobs, I will give you an iPad for the referral! This position is for a CEO in Los Angeles, CA. For more details on this job or to apply simply visit CyberCoders: http://www.CyberCoders.com/qc.aspx?posId=MA1-1183926&ad=CSMelanie.Amarante&enc=fgcfUIG41dC6YVBvVp+XMQ==

Not a fit for this job? Search all of our open jobs: http://www.CyberCoders.com/qa.aspx?ad=CSMelanie.Amarante&sterm=

********************************************************************* Happy 2015! Our startups and affiliates are hiring. See selected openings below. We maintain current job

listings at http://jobs.qb3.org/. If you are interested in SageMedic, submit a resume with a personalized cover letter and your LinkedIn profile, indicating the role you are applying for (e.g. intern, postdoc, consultant), to Christian Apfel, MD,

PhD, MBA, Founder & CEO, hr@SageMedic.com by Jan 30, 2015. Job posting: Biologist/Biomedical Engineer for SageMedic SageMedic is an early stage startup developing an ex-vivo diagnostic assay to improve the outcome of

cancer patients through a more personalized and targeted approach to select the best chemotherapy. We are currently seeking a highly driven biologist and/or biomedical engineer with experience in any of the following: 3D culture of primary tissue, cell-based assays (flow cytometry, FACS, spinning disk confocal microscopy), and/or lab automation.

About two thirds of cancer patients do no respond to their prescribed chemotherapy, owing largely to the heterogeneity of tumors and the resulting uncertainty regarding the best possible drugs or regimen to treat individual cancers effectively. Previous studies have shown that patient survival is much improved in

patients whose first-line therapy leads to a positive tumors response; so we want to get it right, right away. SageMedic was founded by Dr. Christian Apfel, seeking to develop an ex-vivo 3D micro-tumor assay in

order to better personalize chemotherapy treatments based on the patient’s own live cancer biopsy. Despite the buzz that has surrounded the enormous technological advances in sequencing the human genome, only very few patients are benefiting from novel targeted therapies that have been developed for specific mutations, while for the majority of patients the personalization of their cancer therapy has

remained a cumbersome and largely elusive task. At SageMedic our vision is that in five years from now, oncologists will be able to leverage our assay to offer their patients the most effective therapy, personally tailored to their cancer. SageMedic is seeking scientists whose first priority is to make an impact, and who thrive being part of a

team that is passionate about its cause. SageMedic’s culture is fast-paced and highly entrepreneurial, with each member of the team playing a dynamic role, as a scientist, lab manager, engineer, inventor, or lead of a project; and doing whatever it takes to get the work done regardless of time of day. If you join the team you will be expected to leverage all of your qualities: the creativity required to find new ways of

1/18/2015 17

getting the job done; the reliability in execution needed to be thorough, detail-oriented and meticulous in fully documenting your work; and the innovation essential to thriving in a startup that requires a constant supply of new ideas or new ways of approaching obstacles. In terms of skills, SageMedic is accepting applications from scientists with an excellent level of understanding and experience in the following areas: • Cell-based assays, 3D culture of primary tissues, and lab automation • Flow cytometry, fluorescence assisted cell sorting, and spinning-disc confocal microscopy We are less concerned about degrees than confidence in skills and experience, commitment and purpose. Given that SageMedic is still a very early stage company, we are open to all levels of applicants (interns, post-docs, consultants, employee scientist), but we would prefer applicants from the bay area. Interns or post-docs don’t need to have all the technical experience, but need to possess the outlined personality traits and values. Consultants or contractors need significant subject matter expertise to deliver their work within a specific time frame on budget, and if things go well, we hope this can translate into a long term relationship.

_____________________________________________________ Please submit your resume to careers@cairnbio.com

Job Posting: Scientist at Cairn Biosciences Cairn Biosciences is developing the first technology platform for high throughput screening of disease biology in disease-relevant living cells. 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, biological stimuli and disease pathologies. We are seeking an innovative and goal-oriented Scientist with demonstrated expertise in cell biology and

microscopy to join our team in San Francisco. Cairn Biosciences fosters a dynamic start-up environment where self-driven, enthusiastic employees thrive. The successful candidate will be a highly collaborative and effective team-player who is resourceful and open to tackling challenging scientific and technical problems with novel approaches in the lab.

Key responsibilities • Execute customer-requested projects on time and with the highest standards of scientific rigor. • Design and implement experiments and assays as part of grant-funded studies to develop and commercialize our core technology.

• Assist in the design of and budgeting for customer projects and SBIR grant proposals. • Timely and transparent communication of project progress to management and customers and preparation of associated reports. • Assist in authoring content for grant, partnership and investor audiences.

• Monitor and assess literature publications and intellectual property landscape. Required qualifications and experience • Ph.D. or equivalent (M.S. considered) with an emphasis in cell biology, bioengineering, biophysics or a

related field. • At least 3 years of microscopy and related experience (live-cell microscopy experience highly desirable). • Exceptional general laboratory skills. • Strong written and verbal communication skills; able to represent company to partners, customers and

investors. • Excellent attention to detail with strong organizational and documentation skills. • Ability to critically assess scientific findings and publications The following skills and experience are also highly desirable:

• Experimental background in FACS, genome editing (ZFN, TALEN or CRISPR), stable cell line generation and/or iPSC systems. • Hands-on experience with high throughput and/or high content screening and related laboratory automation.

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• Image analysis experience (commercial packages or custom code in R, MATLAB or other relevant programming languages) • 1-2+ years of industry experience in a drug discovery or related setting. • Successful co-authorship of grant applications. Cairn Biosciences is an Equal Opportunity Employer offering a competitive salary and benefits package. For the right candidate, we will consider accommodating a part-time schedule. 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 resume to careers@cairnbio.com _____________________________________________________ Contact Interested, qualified candidates should submit their resume, a cover letter and provide three academic and/or professional references to info@stemcycle.com.

Job posting: Research Assistant at StemCycle Overview StemCycle believes that personalized medicine should be based on empirical evidence, not theoretical

targets. The company is developing a novel diagnostic service using existing technologies to bridge the gap from bench to bedside and provide cancer patients with immediately actionable results. Product

As part of StemCycle’s novel diagnostic service, fresh patient tumor tissue will be cultured and screened against hundreds of FDA-approved drugs to prospectively identify synergistic combinations that the oncologist could prescribe off label. Results will be available within thirty days. Clinical information on the patient's treatments and response will be tracked by the company to link the in vitro results with clinical

data. StemCycle will also establish a tumor bank that will serve as an internal research and development platform for drug repositioning and collaborative pharmaceutical/academic research. Partners will be able to test efficacy of novel compounds in well characterized orthotopic PDX models and evaluate

target penetration before proceeding to clinical trials. StemCycle is initially focused on Glioblastoma Multiforme (GBM), a grade IV brain cancer with no known cure, but plans to expand its platform to other cancer indications in the future.

Background StemCycle was founded by a patient advocate whose father was diagnosed in October 2013 with multi-focal GBM. The genesis of the company’s novel, multimodal approach was developed from this patient’s

dramatic unexpected response to non-toxic combinations of existing FDA-approved drugs and lifestyle modifications. Founder’s Fund, First Round Capital and Accelerate Brain Cancer Cure--a brain cancer venture

philanthropy organization--are seed investors in the company and the founders were recently accepted into Y Combinator, a startup accelerator, for the Winter 2015 cycle. The company is based out of San Francisco with lab space in SoMa and office space in the Presidio.

Job Description StemCycle is seeking a motivated Research Assistant to work directly alongside our Scientist in our lab in SoMa. This is a unique opportunity to gain significant, practical lab experience in a small, fast-paced environment. The Research Assistant will also interface and collaborate on projects with other members of

the team including the CEO, COO and Research Analyst. Qualifications • Experience working in a biology lab including pipetting, weighing and making solutions

1/18/2015 19

• Familiarity with basic molecular biology techniques, for example, PCR, agarose gel • electrophoresis, DNA extraction/purification, and bacterial transformations • Experience with mammalian cell culture, with a preference for individuals who have worked • with primary cultures • Though not required, experience working with mice, FACS analysis or high-throughput • screening is a plus • Keen attention to detail and ability to follow protocols • Good communication skills • Able to work independently and proactively • Interest in brain tumor biology and working in a startup environment ****************************************************************** https://jobs.smartbrief.com/action/listing?listingid=377FC956-EBFD-4206-B980-2D16224EAC12&briefid=3E572E18-3FBC-11D5-AD13-000244141872

Job Summary Date Posted: 12/22/14 Location:

South San Francisco, CA Corporate Counsel - Healthcare Law Group Genentech

Job Description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to developbreakthrough medicines that

improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, CAheadquarters:

Corporate Counsel - Healthcare Law Group Description: The position will have the opportunity to provide legal advice and support across the lifecycle of

Genentech's products, including commercial, medical affairs, development and manufacturing functions. Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs and development teams that have human medicines and companion diagnostics in all phases of development, and manufacturing.

Qualifications: The ideal candidate will have a JD with Bar admission from a top tier law school, and between 3-7 years of relevant legal experience at a law firm with a nationally-recognized FDA / Life Sciences practice or in a pharmaceutical or biotechnology company’s law department, with a focus on counseling pharmaceutical

and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines and companion diagnostics. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech

industries is essential. Successful performance in this role will require a demonstrated ability to deliver sound and concise legal advice in a solution-oriented manner and in the context of evolving business strategy, contribute actively to the legal department by proactively developing opportunities to enhance practice group efficiency, consistently support the need to meet strict compliance requirements, and

effectively present to group audiences. Passionate about our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life.

Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. Apply Below! Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. Genentech is an Equal Opportunity Employer: Minorities/Women/Disability/Veteran

1/18/2015 20

******************************************************************* Contact: Angel Romero, aromero@grnwestpalmbeach.com, 561-422-5150 Associate Director, Marketing ( Instrument Systems) #1665 Our Client is a global diagnostics leader in diagnosing infectious diseases and screening blood at major healthcare institutions worldwide. The position is based out of the company’s California headquarters. Key Duties, Activities and Responsibilities: This role will provide marketing leadership for the systems marketing team and also be responsible for establishing customer facing product positioning for the entire Companies product portfolio. The systems marketing team is responsible for high level product commercial support and portfolio strategy development as it pertains to the NAT analytical systems and pooling products portfolio.

Develop sales tools for use by account managers, and commercial marketing associates for driving NAT sales.

Identify new product concepts and develop business cases for executive management review and approval.

Create tactical plans to expand, support and protect our global market share.

Work closely with the company business partners in order to meet product development milestones and successful new product launches.

Establish self and team as product experts for NAT systems portfolio. Contribute to establishing, influencing and maintaining a global network including key opinion

leaders and policy makers in the blood and plasma screening market. Develop and implement a consistent brand identity across blood and screening products. Utilize the Voice of the Customer for validating customer needs. Represent systems marketing team at global industry meetings.

Accountable for global marketing deliverables as part of product core teams. Responsible for global launch and rollout of NAT analytic and pooling systems. Overall responsibility for NAT analytical and pooling systems life cycle management.

Work Experience, Skills and Education Required:

BS in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA highly desirable

Minimum of 10 years pharmaceuticals/medical devices/diagnostics industry experience with 4-7 years marketing or marketing-related experience preferred.

Product launch, commercial support and product development experience required.

Experience in commercial customer facing role (sales or regional marketing) Comprehensive understanding of the blood screening markets, use of company products, legal and

regulatory issues impacting product marketing Established record getting diagnostic products to market through innovative partnerships and

access programs Ability to take comprehensive scientific data and convert into useful marketing and sales tools Understand global registration requirements in the blood and plasma screening markets Experience presenting to executive management

Leadership skills, including the ability to solve problems Persuasive written and verbal communication skills Previous people management experience.

Associate Director, Market Access, Diagnostics Blood Screening- #1811

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 Associate Director, Market Access, Diagnostics Blood Screening. Position is based in the Bay Area, CA. (alternative location: Washington, DC)

Key Duties, Activities and Responsibilities: The Associate Director, Market Access, Diagnostics Blood Screening will provide leadership for market access activities related to blood safety, with particular emphasis on emerging economies. Secondary this role will serve to support US medical reimbursement activities related to Transfusion Medicine.

Cultivate and execute critical market development efforts, including fostering new client

relationships, communicating the company’s capabilities and value proposition to non-technical stakeholders in government and in the medical diagnostic industry.

Contribute to establishing, influencing and maintaining a network including health economists, payers, payer advisors, clinical opinion leaders, policy makers and patient groups.

1/18/2015 21

Identify key organizations for the company to engage with as it relates to the blood supply chain in emerging economies.

Develop programs and materials such as health economic models for use by account managers, government relations and field staff that integrates information on product value to support strategies for optimizing revenues and reimbursement within specific economies.

Assess economic drivers and strategies to enhance technology adoption and coverage policies among payers

Contribute to establishing, influencing and maintaining a global network including key opinion leaders and policy makers in the blood and plasma screening market.

Provide briefing to the companies management in preparation for key discussions with those who develop and/or advocate policy.

Represent the franchise to external stakeholders, including professional societies, KOLs, government decision makers, quality organizations, patient advocates, and other stakeholder.

Develop a market access vision for the long term, and define short and mid-term measureable milestones.

Work Experience, Skills and Education Required:

BS in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA highly desirable

Minimum of 5-8 years of healthcare industry experience with strong preference for diagnostics experience

Comprehensive understanding of the medical therapeutic area, use of company products, legal and regulatory issues impacting product marketing.

Established record of working with emerging economies to introduce advances to their healthcare system.

Experience with Reimbursement. Familiar with global clinical laboratory operations (purchasing cost drivers, interfaces, logistics, CLIA, CMS).

Familiar with blood and plasma screening customers and purchasing habits Working knowledge of health economic models.

Familiar with the economics of outcome measurements, reimbursement, cost pressures. Leadership skills, including the ability to solve problems, high acumen of influencing skills. Ability to have a vision for the long term, and to effectively communicate it to the company’s

management and to external stakeholders. Ability to network with key influencers within industry.

Persuasive written and verbal communication skills Associate Director, NAT Product Management- CA #1813 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

Associate Director, Nucleic Acid Testing (NAT) Product Management. Position is based in the Bay Area, CA. Key Duties, Activities and Responsibilities: This role will provide marketing leadership for the NAT product marketing team, and is responsible for the

entire on-market NAT portfolio. The NAT product marketing team is responsible for managing voice of the customer, product requirements and overall product management for the company brand.

Provide leadership to the NAT product management team, and directly supervises the product managers for the NAT portfolio.

Establish self and team as product experts for NAT systems portfolio. Utilize the Voice of the Customer for validating customer needs. Responsible for NAT portfolio product life cycle management. Responsible for launching new products and enhancements to current portfolio of products.

Along with product managers, develop customer requirement documents and marketing requirements for new products and enhancements to current products.

Work with marketing manager to develop sales tools for use by regional sales to drive NAT sales. Identify new product concepts and develop business cases for executive management review and

approval.

Analyze the market, to identify growth opportunities. Create tactical plans to expand, support and protect our global market share. Work closely with the company business partners in order to meet product development milestones

and successful new product launches.

1/18/2015 22

Contribute to establishing, influencing and maintaining a global network including key opinion leaders and policy makers in the blood and plasma screening market.

Support the development and implement a consistent brand identity across blood and screening products.

Represent NAT marketing team at global industry meetings. Work Experience, Skills and Education Required:

BS in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA highly desirable

Minimum of 10 years pharmaceuticals/medical devices/diagnostics industry experience with 4-7 years marketing or marketing-related experience preferred.

Experience in commercial customer facing role (sales or regional marketing). Prefer minimum of 2 years outside sales experience.

Product launch, commercial support and product development experience required. Comprehensive understanding of the blood screening markets, use of company products, legal and

regulatory issues impacting product marketing Established record of getting diagnostic products to market through innovative partnerships and

access programs Ability to take comprehensive scientific data and convert into useful marketing and sales tools Understanding of global registration requirements in the blood and plasma screening markets Experience presenting to executive management

Leadership skills, including the ability to solve problems Persuasive written and verbal communication skills Previous people management experience.

Sales Account Executive – San Diego –#1796

A leading global fast growing In Vitro diagnostic company and a world technology leader in the development of fast whole blood analyzers is seeking a Sales Account Executive. Key Duties, Activities and Responsibilities: As a Sales Account Executive, you will be responsible for expanding territory revenues by managing a

complex sales process. You will sell the companies’ full range of blood based diagnostic analyzers and POC meters into hospitals and IHNs. Work Experience, Skills and Education Required:

BA/BS degree Sales experience selling capital equipment into hospitals and laboratories.

Past success calling into multiple points within hospital and/or IHNs is necessary. Experience calling into reference labs will be considered a significant advantage. Your understanding of hospital lab information systems, hospital information systems and

middleware is a plus.

Ideally, you will reside within close proximity of San Diego, CA. Up to 2-3 nights of travel per week is expected.

Regional Sales Manager – West Coast –#1797

A leading global fast growing In Vitro diagnostic company and a world technology leader in the development of fast whole blood analyzers is seeking a Regional Sales Manager. Key Duties, Activities and Responsibilities: In this newly created Regional Sales Manager role, you will be responsible for building and leading a team

of successful Sales Executives and Account Managers. Your team will be dedicated to selling the companies clinical instruments into hospitals and healthcare clinics within your assigned region. Using your well-developed leadership skills, you will effectively manage your team to achieve/exceed your account and sales objective for your region. You will accomplish these goals by hiring top talent and

coaching your team effectively. You will schedule ride-a-longs and work one-on-one with your team members to review: product knowledge, call planning, territory management, relationship building and selling skills. As a successful Regional Sales Manager, you will skillfully manage complex sales cycles and successfully negotiate multi-level committee sales deals, including interfacing with large IHN/GPO customers.

Work Experience, Skills and Education Required: BA/BS Degree Hands-on experience managing a diverse field sales force Significant capital sales experience

1/18/2015 23

Selling medical devices into hospitals and/or large accounts Exceptional sales skill and leadership ability. Significant overnight travel should be expected.

Global Regulatory Affairs Manager – CA - #1779 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 Manager. Key Duties, Activities and Responsibilities: The Manager, Global Regulatory Affairs will be responsible for carrying out logistical activities in relationship to global regulatory submissions for IVD systems (assays, instruments, software). The Manager will also serve as regulatory subject matter expert for design control, development and compliance projects. The Manager will prepare and maintain 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 also represent Regulatory Affairs on project teams to support new products and projects and provide regulatory strategy, risk assessment, and review of project documents.

Prepare regulatory submissions for US and applicable foreign regulatory bodies for in vitro

diagnostic and/or biological products Global responsibility for representing Regulatory Affairs on design and development, post-approval

marketing and partner company project teams Supervise the activities of regulatory 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 Manage partner and critical vendor relationships as appropriate to ensure compliant submissions Participate on multidisciplinary teams focusing on continuous improvement and management

initiatives Demonstrate strong verbal and written communication skills Assume a lead role in the completion of submissions Organize and prioritize work assignments 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 Review, approve, and track workflows and change controls

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 English required

Second language preferred, e.g., Mandarin, Spanish Minimum 5 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

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:

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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

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 Associate Director, Marketing (Immunohematology)- #1812

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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 Associate Director, Marketing (Immunohematology) Position is based in the Bay Area, CA. Key Duties, Activities and Responsibilities: The role will provide leadership for our Immunohematology Portfolio for blood typing, from new product development, to commercial support, and by contributing to the long term strategy of developing new products to address the needs of our customers in the Americas.

Create tactical and strategic plans to develop, support, protect and expand our Immunohematology market share in the Americas commercial area

Contribute to establishing, influencing and maintaining a network including key opinion leaders and policy makers in Immunohematology blood typing

Work closely with company business partners in order to meet product development milestones and successful new product launches

Develop business cases for management review and implementation of new product development or launch of Immunohematology products in the Americas

Develop program and materials for use by account managers, and commercial marketing associates for driving Immunohematology blood typing sales and profitability

Work with global marketing to develop and implement a consistent brand identify across Immunohematology portfolio

Utilize Voice of the Customer for validating customer needs Develop value propositions for key stakeholders in the sales process Develop high gain questions for key stakeholders to support the sales process Organize and lead the companies presence at key transfusion/clinical laboratory

tradeshows/symposiums Work Experience, Skills and Education Required:

B.S. in life sciences or marketing, MBA preferred; Healthcare/Diagnostics experience with MBA highly desirable

Minimum of 5 years industry experience in sales/marketing. Demonstrated knowledge of Immunohematology market and technologies Prior experience working in sales/marketing and development of sales/marketing tools. Excellent oral and written skills communication, ability to communicate professionally with external

customers and Key Opinion Leaders.

Prior experience in new product development and working with CORE development teams Demonstrated high level of organizational, communication, and leadership skills to effectively

interface with all levels of the organization and key diagnostic partners. Resourceful and ability to work in a collaborative team environment with minimal supervision.

Corporate National Accounts Director–CA or Virtual #1777 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 Corporate National Accounts Director-Government executive. The Corporate National Accounts Director-Government plans, develops, and manages long-term relationships with target customer management teams as well as commercial initiatives to achieve or exceed sales targets. This includes development of

strategies and plans that identify opportunities in a direct selling market. This position works independently and with the sales team to promote and manage our client’s portfolio of immunohematology instruments/software and reagents to National Government Accounts groups..

Key Duties, Activities and Responsibilities:

Build strategic customer relationships to foster a long-term relationship that favors our client’s product offerings within the National Government Accounts groups.

Identify account priorities from National Government Accounts groups’ interactions that translate

into business strategies. Work with the field sales teams to develop appropriate strategy to meet customer priorities, including a long-term vision for the partnership with the account.

Demonstrate a broad comprehension of the customer's needs, market trends, industry challenges, major players, relevant products and technologies.

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Bring the breadth of the portfolio, services and solutions, and expertise to the National Government Accounts groups.

Secure and coordinate necessary resources to communicate, deliver, and reinforce our client’s value proposition to the customer.

Develop a detailed account plan/forecast and an operating calendar that serves as the basis for weekly activities for self, and the broader account team.

Maximize, drive and achieve revenue / profit goals and account profitability for assigned accounts. Identify new opportunities that will lead to future sales of strategic and operational importance to

the customer. Effective use of Budget Allocation and Strategic Planning Effective use and monitoring of all travel and expenses Monitor AR Aging report and ensure customers pay their bills on time Generate Sales Reports including targeted accounts and activities to achieve sales and operating

income targets Contract Compliance

o Ensure customers maintain their Inventory at contractually obligated levels

o Generate accurate monthly sales and accrual forecasts Achieve 100% to plan of annual sales and operating income objectives within the product portfolio Responsible for sales pipeline and forecast to close accuracy

Work Experience, Skills and Education Required:

Bachelors Degree

8 or more years of documented success selling capital equipment to National Government Accounts Hospital groups. (Selling capital diagnostics to Government Accounts Hospital based labs-preferred).

Evidenced by stack rankings, awards, and commendations.

Must be team oriented and work well independently. Prior knowledge of accounts in and around defined territory. Must have a hunter mentality and experience working in a commission-oriented environment. Strong written and oral communication skills. Ability to manage sales pipeline and budgets.

Laboratory/diagnostics experience preferred but not required. Ability to travel 80-100%; must live near a major airport hub

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. • Plan and perform integration testing. Establish software ad-hoc testing strategy.

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• 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.

Bio Process Specialist - CA #1663 A global life sciences and medical device manufacturer is seeking a Bio Process Specialist Key Duties, Activities and Responsibilities:

Adhere to Company Corporate policies; local Quality Manual, Health & Safety, travel and IT

policies Responsible for DSP/USP development within the region. Support current Biotech/Vaccine customers and develop new customers within the region and

other regions as required.

Develop strategies (with local management) to maximize the sales opportunities. To educate and advise customers of best suited company technology. To do this, the candidate

must have a good knowledge of company’s technologies and develop a common approach of which product to use and where in a Biotech process.

Be a company expert in integrated Biotech/Cell Therapy processes – primary purpose to increase number of applications that have company specified and therefore increase companies sales.

Work in close relationship with the sales representatives (“account manager”) responsible for the account(s) and local SLS team to coordinate and agree the main activities in the respective

geographic sales area. In conjunction with Marketing, identify new Biotech/Cell therapy opportunities ( from

pipeline/drug tracking information or company start up level, e.g. new CRO / CMO) Generate sales leads and then review with sales management.

Work with Marketing to track and report progress metrics for penetration of drug and cell therapy pipeline.

Contribute to Sales and Marketing in the planning and presentation of Biotech seminars. Develop expertise by regular pan regional and global communication – exchange of

experiences, applications and technology training. Coordinate the identification and generation of necessary technical documents for internal and

customer use. Perform and coordinate bench scale test work in conjunction with the SLS Team to

demonstrate how to get the best out of company’s products. Work closely and have regular contact with the Level 3 Sales / Technology Specialists to

facilitate technical project and/or account handover when appropriate. To work in close relation with Applications R&D and / or the other teams to assist in the

development of companies application platforms in the various Biotech processes. Contribute to tactical/ strategic plans as requested by commercial. Maintain up to date awareness of relevant technical developments. Experience and skills to be used anywhere in region. Ability to plan and organize test work

Ability to communicate both verbally and in writing Ability to give presentations at conferences, events. Ability to operate as a member of a multidisciplinary team including sales, marketing, SLS etc Knowledge of scientific principles and practices relevant to Biotech customers and processes

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Knowledge of Industrial fermentation/cell culture, separation or process analytical technologies is an important added value

Good interpersonal skills to motivate others Ethical and scientific behavior An awareness of the cost effectiveness of individual projects and their resultant financial

implications Work Experience, Skills and Education Required:

2-3 years minimum relevant experience BA Degree (or equivalent) Working and traveling outside of normal business hours 50% + travel within U.S., Canada and Latin America Experience in Biotech industry MSc or Higher in Biochemistry, Chemical Engineering or Life Science Bio)/Engineering ( Bio)

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

http://jobs.qb3.org/. Contact: Please send your resume to Varun Boriah (varun@caydian.com) and include “Engineer Position”

in the subject line of your e-mail. Job position: Engineer at Caydian Consumer Health

We are looking for engineers to develop smart, connected consumer devices that help parents improve their child’s sleep. Role: We are currently looking for an embedded systems/sensor development/hardware engineer to join

the team on a part-time or full-time basis. Responsibilities: • Engineering lead on the design and development of the electronic hardware and firmware used in a new children’s sleep consumer product.

• Early stage product development with opportunity to lead transfer to manufacturing and new product introduction. • Work with all cross-functional teams (software, product design, mechanical engineering, operations, finance, etc.) to deliver a successful product to market.

Background: • Marked excitement about embedded systems/HW design, and a solid track record with some product development history to prove it.

• B. S. or M.S. in Electrical Engineering or related field (Embedded Systems, Mechatronics). • Familiarity with non-contact sleep monitoring systems or sensors (accelerometers, piezo film sensors, force sensors) a BIG plus. • Experience specifying and sourcing components for early stage product development.

• Proficiency in debugging interdisciplinary electro-mechanical systems with any/all appropriate tools or scripting languages. • Extensive experience in developing C on various microcontroller platforms.

Bonus: • Knowledge of mechanical design software such as Solidworks or ProE. • Strong C/C++ with complex system architecture/design. • Python or Java experience a plus.

Company:Caydian, a Stanford Biodesign spin-out and StartX incubated company, is developing smart consumer wellness products that help parents improve their child’s sleep. Our first product, the Caydian Dream, is a non-contact device that is discreetly placed under the child’s mattress, and uses a scientifically proven sleep optimization system to smooth out the troublesome parts of children’s sleep.

1/18/2015 29

******************************************************************************************************************************* Interested and qualified candidates are encouraged to register and apply at https://nsfsbir.asee.org/ . CV's or bio's as well as any questions can be sent to fellowships@elutionsinc.com Job position: NSF Postdoctoral Fellowship at eLutions Inc. We are pleased to announce an NSF postdoctoral fellowship available for one year, extensible for two that might be of interest to the UCSF community. I am attaching the post on Nature describing the opportunity as well as the full description below -- http://www.nature.com/naturejobs/science/jobs/471463-asee-nsf-postdoctoral-fellowship-in-chemometrics-spectroscopy Raman Spectroscopy & Chemometrics Fellow for SBIR Award Title “A Miniaturized Raman Optical System for Trending Glucose Levels”

SBIR Award Abstract This Small Business Innovation Research (SBIR) Phase II project shall prototype a wearable Raman optical system to monitor trending blood glucose levels noninvasively, continuously, and in real-time. A solution that is unobtrusive, long-running, and provides absolute glucose readings with minimal calibration is

considered a "holy grail" for patients with diabetes mellitus. In the vast divide between this aspiration and the default regimen of multiple daily fingerstick measurements for single-shot glucose readings lie incredible opportunities for improvement in self-regulation and patient-specific care. Our goal is to miniaturize a Raman system into less than 10 cubic centimeters to enable transcutaneous glucose

detection. Sufficient accuracy is sought so that analysis of collected data allows clinicians to provide better individualized care than is possible with either isolated fingerstick data or two-month-averaged glucose levels inferred from glycated hemoglobin (HbA1c) readings. Using a novel optical configuration developed in Phase I, further miniaturization in Phase II will reduce our laboratory bench-top system to a handheld

platform that is an order of magnitude smaller and maintains the necessary throughput and sensitivity to detect glucose ex vivo. This Phase II effort will also investigate the core problem of repeatability plaguing almost all optical approaches for noninvasive glucose detection. Specifically, it will be addressed for the Raman-based spectroscopic configuration explored in Phase I. Optical as well as mechanical techniques will be employed to introduce stability into the system to mitigate contributions from ambient mechanical

and physiological perturbations and disturbances that cause errant readings, throw off calibrations, and frustrate end users. Testing and validation of these techniques will be performed ex vivo, using disposed skin, tissue and blood samples to create model analogues in place of animal or human transcutaneous testing. This minimizes initial regulatory overhead while providing essential test data to ascertain

detection limits, capacities for overcoming repeatability, and practicalities for usage in real-world scenarios. The end Phase II milestone is to deliver a prototype for demonstration that is capable of sufficient sensitivity, and stabilized detection and quantification of physiological levels of blood glucose that can be readied for wearable and ambulatory settings. Overcoming this key hurdle

is a necessary step to advance all such optical technologies for transcutaneous detection, and one which will engage potential customers and investors for continued support toward commercialization. less Research Opportunity

Title: Raman Spectroscopy & Chemometrics Fellow Number of Fellows: 1

Open for Applicants: Yes Description eLutions Integrated Systems, Inc., founded in 2011, is an NSF- and NIH-funded for-profit venture developing systems and engineering solutions for in vitro and ex vivo medical diagnostics. eLutions is in

early R&D stages, designing customized laser optical spectroscopy tools for applications in diabetes and its affiliated complications. Our sights are on developing a wearable noninvasive optical glucose sensor for routine out-patient use while building critical infrastructure and intellectual property to strengthen and protect our position. eLutions is unique in that we value scholarly research and science as

1/18/2015 30

much as we are driven by business sustainability and viability with a longer-term purpose and vision. Core to our technology is developing exceptional signal processing and mathematical capabilities that allow us to identify and quantify the spectrum of a specific biomarker under the cover of a large background. This type of data analysis when applied to spectroscopy and chromatography termed "chemometrics". We are looking for a well-qualified candidate to develop, optimize, implement, and integrate the necessary algorithms into our optical data data collection system for selectively and sensitively measuring biomarkers of interest. Desired Knowledge One significant challenge with Raman spectroscopy lies in detecting low-level signals above a large and noisy background. This noise can be random and nonlinear, but can also be predictive / deterministic. Along with the spectral signature of the analyte of interest, ambient stray light, fluorescence, and the measurement apparata all affect the spectral signal that is collected. Our aim, therefore, is to identify and to quantify very specific biomarkers under these nonideal and often uncertain conditions that exist in practical end-applications.

The proposed approach is to develop a robust chemometrics modeling tool that either is built from scratch (using tools such as MATLAB, Mathematica, R, or directly in C++) or leverages off-the-shelf analytical tools (e.g. http://www.eigenvector.com/, UnscramblerX) that enable the controlling knobs to account for

spectral variability attributed to the signature of the sample itself, the convolving effects of the measurement set up, and the influence of varying ambient conditions. We believe the ideal candidate will have a strong foundation in mathematics, linear algebra, and signal processing, with an interest in developing numerical software tools and models. These skills could be

acquired via direct experience in chemometrics as used for spectroscopy tools, whether in Raman, or in fluorescence, absorbance, FTIR or others. Such skills, especially as they are relevant to understanding optics, lasers and detector limitations, are useful in providing a practical basis for the tools to be developed under this proposed fellowship.

While the former paragraph describes an ideal fit, we are open to all interested candidates that appreciate and can contribute to developing solutions in this challenging and emerging "big data" space. NSF Small Business Postdoctoral Research Diversity Fellowship Program Administered by: American Society for Engineering Education (ASEE) | www.asee.org

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

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/

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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 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.

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Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and

organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume

with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description.

This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 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

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earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most

recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility.

10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume

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.

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I googled Amazon’s top books for job hunters and writing resumes and found a list including one of my favorites What Color Is Your Parachute? 2013: A Practical Manual for Job-Hunters and Career-Changers by Richard N. Bolles. I found this book especially useful in helping me determine what types of job functions I liked best. ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • enewsletters@fdanews.com PharmExecBlog.com at http://blog.pharmexec.com/ on the business of pharma http://realendpoints.com/blog/ on pricing and reimbursement Luke Timmerman’s blog on Xconomy. ********************************************************************* 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. *************************************************************************

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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/

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. *************************************************************************

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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. *************************************************************************