5/3/2015 1

Jobs That Crossed My Desk Through May 3, 2015 Complimentary Service of Audreysnetwork.com

May 3, 2015

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Note that recently I’ve begun to receive many listings via Linked In and in such cases, I’ve listed company website if not person who sent listing to me. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you

find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG

meetings to become member but application in free. See details at www.bio2devicegroup.org. Next BioSpace Career Fair in Bay Area scheduled for Oct. 28, 2015. See details at http://www.biospace.com/jobs/career-fair/

************************************************************************* Jobs at QB3 companies appear below. SENIOR BIOINFORMATICS SCIENTIST, Miroculus POSITION DESCRIPTION Miroculus is inviting applications from experienced bioinformaticians with strong computational background and expertise in non coding RNA biology. The senior bioinformatician will design and implement algorithms that support goals of project teams. This position reports to the CSO and works closely with the executive team. We are looking for creative and highly motivated individuals who can design traps for specific RNA targets. For this, it would be good to have experience with miRNA or RNA calculations, folding and primer design. Experience with functional analysis of small RNA expression profiling data from qPCR, microarray and NGS is a plus. Our team is international, interdisciplinary, fast paced and used to excellent communication and teamwork skills. The candidate should feel comfortable functioning within a small and rapidly growing company. REQUIREMENTS: Ph.D. in bioinformatics, biostatistics, computer science, or a related discipline Solid biostatistical knowledge and practical experience using bioinformatic applications Experience with miRNA or RNA calculations and folding Computational Biology, Bioinformatics, Biomedical Data Analysis Strong programmatic skills in languages such as Perl, Python, R, Java, C/C++, database querying languages (SQL) BENEFIT TO HAVE: Primer design and evaluation NGS (including RNA-Seq, small-RNA-Seq, ChIP-Seq, CLIP-Seq, etc) data analysis and integration.

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Experience in design and implementation/development of novel algorithms and automated pipelines to support large-scale bioinformatics analyses Functional data interpretation, network design and biological systems modeling (e.g. co-regulated gene networks linked with biological pathways) Non-coding RNAs (miRNAs) and post-transcriptional regulation mechanisms. LOCATION Full time position in our lab space at QB3 in San Francisco If you would like to apply for the Senior Bioinformatics Scientist position, send us your bio and publications at jobs@miroculus.com ________________________________________________________________________________ Two positions: Mission Bio 1. Scientist (Molecular Biology), Mission Bio OVERVIEW Mission Bio, Inc. is a startup venture founded on microfluidic droplet-based technology developed at the University of California, San Francisco (UCSF). We provide services and instrumentation that accelerate the investigation of cellular heterogeneity by rapidly and accurately performing single-cell transcriptional profiling and genotyping. Mission Bio operates out of the QB3 biotech incubator in San Francisco. We are a small team that is growing rapidly, so this is an opportunity to make a significant impact on the direction and success of the company. DESCRIPTION Mission Bio is currently looking for a highly motivated and qualified individual to assist in the development and commercialization of a platform technology, PCR-activated cell sorting (PACS). PACS will be broadly useful in life science research, allowing users to rapidly analyze and sort large populations of cells based on single-cell multiplex TaqMan reactions performed in microfluidic droplets. This approach will enable characterization and sorting of heterogeneous cell populations by targeting nucleic acid biomarkers not identifiable with existing sorting technologies. The candidate will primarily focus on optimizing the current platform and enabling downstream molecular characterization of sorted single cells. The successful candidate will also assist in early stage research into future single-cell genomic and transcriptomic technologies aimed at expanding the Mission Bio product portfolio. QUALIFICATIONS • We are looking for a motivated and independent scientist who is excited by the opportunity to make an impact at a fast-paced, multidisciplinary startup environment • Must be detail oriented and highly motivated to do bench research. Research excellence must be demonstrated through publications, presentations and other accomplishments. • Ph.D. in molecular biology, biochemistry, cell biology or similar discipline. • Extensive molecular biology experience is required. Examples include: nucleic acid amplification strategies, primer design, next-generation sequencing and other methods for gene expression analysis. • Experience applying the above molecular biology methods to the analysis of single cells, or knowledge in the fields of genomics and transcriptomics is highly desirable. • Must be able to design and perform experiments, analyze data, perform troubleshooting and optimize protocols with minimal supervision. • Experience with basic mammalian cell culture techniques or handling of clinical cell samples considered a plus. • Knowledge of a programming language preferred (e.g. MATLAB, Labview) • Must be eligible to work in the U.S.

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Candidates interested in this position should submit their resume to jobs@missionbio.com. 2. Research Associate, Mission Bio DESCRIPTION Mission Bio is currently looking for a highly motivated and qualified individual to assist in the development and commercialization of a platform technology, PCR-activated cell sorting (PACS). PACS will be broadly useful in life science research, allowing users to rapidly analyze and sort large populations of cells using single-cell multiplex TaqMan reactions performed in microfluidic droplets. This approach will enable characterization and sorting of heterogeneous cell populations by targeting nucleic acid biomarkers not identifiable with existing sorting technologies. The candidate will primarily focus on running and optimizing the current PACS platform as it is applied to diverse biological applications. The successful candidate will also be called upon to assist early stage research on future single-cell genomic and transcriptomic technologies aimed at expanding the Mission Bio product portfolio. QUALIFICATIONS • Excited about working in a fast-paced multidisciplinary startup environment. • B.S. with lab research experience in molecular biology, biochemistry, cell biology or similar discipline. • Must be detail oriented and highly motivated to do bench science. • Willing to take on a diverse set of lab responsibilities and rapidly learn new methods including microfluidics. • Familiarity with common molecular biology methods like nucleic acid amplification and gene expression analysis desired. • Must be able to design and perform experiments, troubleshoot and optimize protocols independently. Ability to conduct basic data analysis is also desirable. • We prefer a candidate with biotech industry experience. • Proficiency with basic mammalian cell culture techniques or handling of clinical cell samples considered a plus. • Must be eligible to work in the U.S. Candidates interested in this position should submit their resume to jobs@missionbio.com. >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Position: Quality Engineer consultant, Neurosave Requirements: • Driven & hands-on individual who can work with a very small team and have a big impact on the development process. • Relevant degree in Engineering. • Minimum 4 years in Medical Device/ Quality Engineering / Manufacturing experience. • Considerable hands-on experience in Medical Device R&D strong working knowledge of FDA QSR, MDD and ISO 13485 & ISO 14971 Risk Management. • Experience with Human Factors, Voice of Customer, ASQ Sampling Plans and Supplier Evaluation & Management a plus. • 60-80% FTE needed Responsibilities: • Partner with R&D Engineering to develop appropriate development & Design Control documentation for the Medical Device product. • Support preparation of documents and participate in design reviews • Identify improvements based on relevant risk analysis, past manufacturing experience, and specifications & requirements for products. • Ensure compliance with design controls and ISO13485 • Work with Senior Quality advisors to identify gaps and implement solutions as needed • Liaise with external Manufacturing partner to ensure successful design transfer and quality product manufacture &

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release. • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. • Evaluate and implement protocols and methods (including SOP’s) to ensure that incoming material and manufactured products are compliant with internal requirements. Contact Shadi Haag for more information: shaag@neurosaveinc.com ************************************************************************************ How to Apply Please visit http://www.chemocentryx.com/careers/job.html#PAAPA to apply online. All ChemoCentryx employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts, and a comprehensive benefits package, including medical, dental and vision coverage and life and long-term disability insurance. EOE Patent Agent / Associate Patent Attorney

Job ID: 23544571

Position Title: Patent Agent / Associate Patent Attorney

Company Name:

ChemoCentryx

Industry: Biotech

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

Posted: April 30, 2015 Job Function: Patent Litigation Entry Level: No

Job Type: Full-Time

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Job Description Patent Agent / Associate Patent Attorney

Flexible Title - commensurate with the candidate’s background and experience ChemoCentryx is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered small molecule therapeutics that target the chemokine and chemo-attractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. We are

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

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

the Company’s intellectual property

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

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

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

patent counsel Manage outside patent counsel activities and interactions Process invention assignments and declarations

Review and execute material transfer agreements, confidentiality disclosure agreements, technology transfer agreements and other legal instruments such as contracts

Manage external collaborations Review ongoing scientific developments by the Company’s research and development teams

Review abstracts, posters and publications prepared by the Company’s research and development teams prior to submission

EDUCATION AND EXPERIENCE Bachelor of Science degree in Chemistry (organic/medicinal) or Biochemistry

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Minimum of 5 years of professional experience in preparation and prosecution of chemistry (mainly small molecules) and biochemistry/biology patent applications

At least 3 years of which were spent as a patent agent or in a related role(s) within a biotechnology, pharmaceutical or related industry

Admission to USPTO as a Patent Agent required Demonstrated knowledge of the domestic and international laws, regulations, and processes

relating to chemistry (mainly) and biochemistry/biology patents and applications Knowledge of the standard concepts, practices, and procedures of the patent agent function within

a pharmaceutical or related industry Experience using IP software and systems such as ChemDraw, USPTO website, web-based

scientific research applications such as SciFinder and docketing, research database and other relevant software

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

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

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

strong medical device experience. Please also notice contract opportunities at the end. All US opportunities are for US based and local candidates. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

This is a photo symbolizing the job search in today’s economy. Out of the darkness, there seems to be a ray of hope–but where? (Photo credit: Wikipedia) Director of Mechanical Engineering – San Jose, CA Requires 20+ years experience in polymers, balloons manufacturing. Complete details will be posted soon.

Mechanical Engineer – San Jose, CA Requires 5+ years medical device experience. Details will be posted soon. Quality Engineer – San Jose, CA Requires BS in Engineering and 10+ years medical device QE experience. Details coming soon. Physiologist – San Jose, CA

Requires large animals survival surgery experience. Details coming soon. Biochemist – San Jose, CA Requires PhD + 3-5 years industry experience. Details will be posted soon. Ruby on Rails Engineer – San Mateo, CA

Senior Electrical Engineer – Austin/ San Antonio – TX A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience. Experience with closed loop, analog design hardware, microcontrollers, actuators and ultra low power consumption circuit design highly desired.

Key Responsibilities * Lead Electrical Engineering, primarily for long-term implantable drug delivery devices: * on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems

* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics * Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically

sealed and packaged and interface with rest of electronics systems for developed products * Establish reliable suppliers and partners for manufacturing * Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment * Document work output and use project and organizational documentation systems, including electronic

systems * Plan for and support existing and projected growth of the company. Key Qualifications * Designed and implemented electronics mixed-signal hardware, firmware and software for implantable

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medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable * Bachelor’s degree in Electrical Engineering or in an equivalent field required * Led and grown EE groups with a hands-on, leadership- by-example approach * Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters * Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus. * Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development * Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics. * Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical

and business. * Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity * Analytical data-driven problem solver and team player, organized and an excellent communicator

* Supported multiple complex projects in a start-up environment: able to prioritize. Key Job Parameters * Full-time position located near Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities

* Report to VP, Product Development Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA A reputed contract engineering company has an immediate full time opportunity for a Senior Design Engineer with Embedded Hardware & Firmware Skills. A rounded individual is desired who has an interest

and ability in a wide range of technologies. The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times. The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work. The person must enjoy working with customers and have good communication skills. The person must work well on a team of high performing engineers. The person

needs to be organized. The person must work well with others and be flexible as schedules and priorities change. Technical requirements: Ten years of experience in embedded system design engineering is required. Ability to supervise others is highly desired. The person should have experience designing circuits with

microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices. The person must enjoy learning and be able to learn quickly. The ability to design and program FPGAs is desired. This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA See full description in March Job posting. Senior Quality Engineer – Austin/ San Antonio – TX A company working on innovative drug delivery technology has an immediate opening for senior quality

engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks. Key Responsibilities: * Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE

and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation * Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III

implantables * Implement productive relationships with R&D and manufacturing suppliers and partners * Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment

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* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation * Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist Key Qualifications * Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable* * Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable * Led and grown QA organizations with a hands-on, leadership- by-example approach * Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business. * Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE

* Supported multiple complex projects and start-ups: able to prioritize. * Developed and implemented design controls, documentation, and design procedures, protocols * Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices

* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity * Analytical data-driven problem solver and team player, organized and an excellent communicator Key Job Parameters

* Full-time position located in Austin/ San Antonio, Texas * Some travel (~10%) may be necessary to meet job responsibilities * Report to VP, Product Development Contract Opportunities with skills in following areas – San Jose, CA

* Electrical Engineering & Software * Analog Design * PCB Layout (FR4, Flex etc.) * ASIC Design * Embedded Systems

* TI MSP430, ARM, Cypress * Software (Windows, Linux, C++, Android, iOS) * Sensors * RF Communications

* Bluetooth, Wi-Fi, 3G, 4G, GPS * Antenna Design * RF Test Labs * Test Engineering

* Test Hardware & Software * Manufacturing Engineering * Fixture Design * DFM, DFT (Design for manufacturing, Design for Testability)

* Process Development * Machine Shop Support ************************************************************************************

* mp@hechkoff.com

APPLY FOR THIS JOB

Contact Person: Maria Pell

Email Address: mp@hechkoff.com

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

5/3/2015 8

Head of Communications

Job ID: 23321319

Position Title: Head of Communications

Company Name:

Prothena

Industry: Biotechnology

Job Function: Communications

Entry Level: No

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

Posted: April 16, 2015

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: Over 10 Years

Required Travel: None

APPLY FOR THIS JOB

Contact Person: Maria Pell

Email Address: mp@hechkoff.com

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

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Job Description

Responsibilities: The Head of Communications will:

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

government relations initiatives. Develop and manage all communications – examples include: internal and external

collateral/publications, executive presentations and speechwriting, webcasts, industry and financial press releases, on-line/electronic communications, quarterly earnings announcements, annual report and web content.

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

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

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

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

Job Requirements

Qualifications: Ideal candidate will have a minimum of 10-15 years of investor and corporate communications experience in a corporate or agency setting with responsibility for the strategic direction of such programs. Biotechnology/biopharmaceutical, pharmaceutical, life sciences or related industry as well as previous experience communicating similar business models to external audiences is required. In addition, the successful candidate:

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

Must be results oriented with tenacity to drive efforts from concept to development to implementation. High energy, adaptability and integrity. Self-starter with high standards of performance.

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

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

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

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

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

Should have financial and analytical skills with demonstrated ability to interpret information for the investment community and senior management.

Must possess excellent oral and written communications skills and have the ability to work independently in a fast-paced and fast-tracked environment. Ability to translate scientific concepts into language for the lay public.

Candidate should have excellent computer-based skills and presentation skills.

Candidate should be able to manage agencies, vendors and budgets for delivery of on-time and on-budget deliverables.

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

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

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

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

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

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

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

excellent judgment. Candidate should be able to prioritize multiple expectations based on the Company’s strategy and

goals, providing focus for and setting expectations with internal business partners. Candidate will tackle role with passion, commitment, enthusiasm and a can-do attitude.

Candidate must work well in a team environment to influence common goals to ensure an integrated approach in pursuit of business goals, and will take on additional responsibilities/special projects, as needed.

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

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

Managing Director Hechkoff Executive Search Inc. ******************************************************************************* APPLY FOR THIS JOB

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

Senior Counsel Patent Biology

Job ID: 23342105

Position Title: Senior Counsel Patent Biology

Company Name: Amgen

Posted: April 17, 2015

Entry Level: No

Job Type: Full-Time

5/3/2015 10

Industry: Biotechnology

Job Function: Legal Affairs

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

Job Duration: Indefinite

Min Experience: 3-5 Years

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Job Description

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

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

counsel to R&D and business personnel on a variety of IP related matters. The Senior Counsel will work individually and in legal teams and cross-functional R&D and business teams.

The position may be based at Amgen’s South San Francisco, CA site or at Amgen’s Thousand Oaks, CA site. Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for

employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status. To learn more about this position and to apply online, please visit www.amgen.com/careers (search under Job Number 31093BR).

Job Requirements

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

Preferred Qualifications: - 10 plus years of experience practicing patent or intellectual property law - Experience in all aspects of U.S. and foreign intellectual property law relating to biotechnology, preferably in the pharmaceutical industry with a law firm or corporation. - An advanced degree or experience in biology - Excellent analytic, legal drafting and oral and written communication skills. - Strong management and leadership skills as well as a strong client service focus and the ability to work independently and in teams; ability to work efficiently, to prioritize workflow, to meet demanding deadlines, and to manage multi-dimensional projects in a fast-paced

environment.******************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=ED2ECBE2-B8A0-4303-8405-0ED74DB32E86&briefid=263A5F36-6763-46C7-B399-4428C3A9FD06&industryid=F874EF19-DAEB-4522-

9498-02D50BEC5D3F Job Summary Date Posted:

4/22/15 Location: Santa Clara, CA Salary Range:

Open Project Manager RA - 15000003MD Abbott Job Description

5/3/2015 11

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

Supervisory / Management Responsibilities: Individual provides leadership without direct authority (i.e., project leader). Individual may provide direction and guidance to exempt and non-exempt personnel who exercise significant latitude and

independence in their assignments. Also may mentor other department members. Position Accountability / Scope:

Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction

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

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

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

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

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

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

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

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· Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education: Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Minimum Experience / Training Required: 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific

affairs, operations, or related area. Note: Higher education may compensate for years of experience.

********************************************************************************** Candidates can send a resume to Angie.Brunet@carefusion.com or apply online:

Job Summary Date Posted: 4/21/15 Location: Palm Springs, CA

Years Experience: 10+ This Job appears in

AdvaMed SmartBrief

Director, Site Quality Management CareFusion Job Description Life-changers work here

CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical

challenges. Meet one of our Life-changers. http://www.youtube.com/carefusion

Job Title: Director, Site Quality Management https://cfn.taleo.net/careersection/2/jobdetail.ftl?job=150500B2&lang=en&sns_id=mailto CareFusion Business Description At CareFusion (NYSE: CFN), we are united in our vision to improve the safety and lower the cost of

healthcare for generations to come. Our 14,000 worldwide employees are passionate about healthcare and helping those that deliver it - from the hospital pharmacy to the nursing floor, the operating room to the patient bedside.

5/3/2015 13

Our clinically proven product families include Pyxis® for medication and supply dispensing, Alaris® for infusion, AVEA® ventilators, Jaeger® for respiratory diagnostic instruments, AVAmax® and PleurX® for interventional procedures, V. Mueller® and Snowden-Pencer® surgical instruments, and ChloraPrep® skin antiseptic. To make global healthcare better, we partner with our customers to help them improve medication management, lower costs in procedural areas, reduce risk of infection, advance the care of ventilated patients and turn the endless amount of data generated in healthcare into actionable information. Learn more at www.carefusion.com Accountabilities The Director, Quality Management (Palm Springs, CA - relocation assistance is available) is responsible for providing tactical direction and management of quality and compliance activities, global supplier management, manufacturing, distribution and materials quality. This includes ensuring that products, processes and materials meet specified requirements, verifications, validations and other documentation

that supports DHF, DMR and DHR. Responsible for ensuring that all aspects of quality systems including design, production, and post market surveillance by working with functional leaders in a matrix organization. The scope of responsibility spans material quality at source suppliers and continues through the full product life cycle.

In addition, the Director, Quality Management will be accountable for the following:

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

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

As the designated management quality system representative, recommends/makes quality system

changes where needed to measurably improve quality/customer satisfaction Provides direction and leadership to the business unit management regarding significant product

and service quality decisions. Provides quality trend information to aid in achieving those objectives.

Provides direction and leadership including change management to plant quality assurance

managers in order to maintain and improve quality operations within the plant. Primary liaison with FDA and international regulatory authorities for quality system compliance

audits and all product actions Provides active leadership in application of lean six sigma tools and methodologies to improve plant

compliance, product quality, and cycle time in quality performance. Liaise between the business unit, manufacturing, sourcing, R&D, regulatory affairs, customer

advocacy and corporate quality on quality matters. Initiate and direct corrective actions related to product or process quality, including redesigns for

complaint resolution, exception management, and field corrective actions. Ensures integrity of Product and Process Risk Management Responsible for Incoming material inspection process Responsible for distribution quality

Provide leadership and direction to site QA management in order to continuously improve product and process quality and regulatory compliance

Provides periodic detailed status reports to management demonstrating performance to department objectives, capital and expense budget and employee development initiatives.

Recruit, retain, train, develop, manage and lead quality talent Manage departmental spending to the established budget(s) and lead departmental financial

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

"new ways", emphasizing and demonstrating operational excellence, while understanding the

impact of change on the team and developing strategies to ensure continued team success Creates relationship internally and externally to reach consensus on complex strategic issues,

leveraging cultural and individual differences among parties to maximize success and drives team through ambiguity; champions team decisions

5/3/2015 14

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

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

10 years of experience in a Quality role within a FDA regulated environment Manufacturing Quality leadership experience required 5 years of direct management experience required Strong leadership, communication, and collaboration skills required Ability to convey complex ideas, impressions, and information to negotiate an outcome or influence

events Inspirational leader Strategic thinking and managerial courage required Customer and patient focused individual Application of Lean Six Sigma to manufacturing processes required

LSS Black Belt Certification is highly desired ASQ certifications in quality management, quality/reliability engineering, and/or quality auditing

are highly desired CareFusion is an equal opportunity employer. All qualified applicants will receive consideration for

employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.

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

Sr Regulatory Analyst

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

for providing Regulatory Affairs support...

Thermo Fisher Scientific

S. San Francisco

05-10 Years

04/23/15 Active

Regulatory Analyst

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

CMDL...

Thermofisher Scientific

Pleasanton, CA

01-05 Years

04/23/15 Active

Engineer Opportunities in San Jose include Director of ME, ME, EE, QE, Biochemist, Physiologist and so on. Details will be posted soon at...

Winning Difference

United States

00-01 Years

04/20/15 Active

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

5/3/2015 15

Salary Range: Open Project Manager RA - 15000003MD Abbott Job Description Primary Job Function: As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide. Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

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

direction and guidance to exempt and non-exempt personnel who exercise significant latitude and independence in their assignments. Also may mentor other department members. Position Accountability / Scope:

Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met. Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements. Work is performed without appreciable direction

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

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

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

activity across organizational units. · May lead a cross-functional or cross-divisional project team.

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

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

5/3/2015 16

· Forecasts project related needs including human and material resources and capital expenditures. Decision Making/Impact: · Assignments are expressed in the form of objectives · Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. · Consequences of erroneous decisions or recommendations would normally include critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity. Minimum Education:

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

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

in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

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

Jobs That Crossed My Desk Through April 19, 2015

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

http://jobs.bio.org/jobseeker/search/results/?site_id=15768&keywords=jobs+in+California

Senior Counsel Patent Biology

Amgen

Thousand Oaks,

California, United States

04/17/2015

Head of Communications

Prothena

South San Francisco, California, United States

04/16/2015

********************************************************************************** Wirth & Associates is a Pharmaceutical, Biotech and Medical Device Executive Search Firm. Below is a list of our current openings, if you have any referrals or have any staffing needs please contact our office for more information, referrals are Confidential.

Nancy Cody Wirth & Associates wirth@wirth-associates.com

________________________________________________________________________________________ General Manager/Plant Manager TX

5/3/2015 17

15 years in the pharmaceutical industry with five years of senior management experience. Strong manufacturing and technical background preferred. Gmp Liquid and cream .... OSD is a plus but not required. ________________________________________________________________________________________ Director, Method Validation CA Position Summary: The Director of Method Validation is responsible for providing the day to day leadership and analytical chemistry and regulatory guidance to the Method Validation and Method Transfer sections of R&D Analytical Sciences. The responsibilities include the supervision of staff and validation projects for solid dosage and other forms from both generic and brand development areas. The

responsibilities also include timely completion of validation to support ANDAs/NDAs, response to FDA deficiency letters, transfer of methods to the QC laboratories or third party and introduction of new technological initiatives.

________________________________________________________________________________________ Sr. Director, Engineering Taiwan

Solid Dose Experience. Manage the Engineering group in development of project scope, design, and construction of projects within agreed cost and schedule parameters.

________________________________________________________________________________________ Sr. Mfg Engineer Southwest

Tech Ops. Working on a project team responsible for the technical transfer of pharma products into CMO. Equipment specification/qualification, batch record writing, SOP writing, etc. Process improvement projects dealing with pharmaceutical

processes. 5-10 years experience. ________________________________________________________________________________________

Director, Analytical and Microbiology Southwest Provide scientific and operational leadership to the analytical and microbiology GMP laboratories ____________________________________________________________________________________

____ Project Manager Southwest

Pharma experience. Manage technical transfer of clients products into the CMO site. Includes clinical and commercial products. Background in mfg, eng, laboratory, etc. ____________________________________________________________________________________

____ Project Engineer Southwest Syringe facility. Specification of utility equipment, project oversight, project schedule, construction

5/3/2015 18

oversight, FAT/SAT/commissioning etc. ________________________________________________________________________________________ Validation Engineer Southwest Pharma experience 3-6 years, equipment qualification, requalification work, protocol/acceptance report writing. ________________________________________________________________________________________ R&D (formulator). Pharmaceuticals TX Solids and Liquids Manufacturing facilities, generic pharmaceuticals.

________________________________________________________________________________________ Validation Engineer

TX Pharma experience 3-6 years, equipment qualification, requalification work, protocol/acceptance report writing. Troubleshooting. Oral solid and liquid products

________________________________________________________________________________________ Director of Toxicology Services Northwest

The Director of Toxicology Services has management oversight of the in life portion of preclinical studies. Responsible for developing and administering the programs, directing the training of employees, identifying optimal practices and facilitating change to improve efficiencies and compliance throughout the department.

________________________________________________________________________________________ Quality Assurance Associate

Northwest The Quality Assurance Associate will coordinate auditing activities to ensure compliance with SOPs and GLP requirements.

________________________________________________________________________________________ QA Computerized Systems Auditor Northwest

Performs audits of computerized systems, processes, procedures and functions to ensure compliance with 21 CFR Part 58 and Part 11 requirements. ____________________________________________________________________________________

____ Sr. Director, Global Manufacturing Technical Services CA

This Global position has the primary responsibility for assuring that adequate technical support is provided across all manufacturing and packaging operations.

5/3/2015 19

Clinical Project Manager. S.CA Dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries. ________________________________________________________________________________________ Sr. Proj. Engineer/Manager TX Mechincal/Chemical Engineer. Strong Semi Solids experience. 10m+ Projects, Budgets, Packaging, Remolding. This role is responsible for leading, coordinating and managing facility, equipment , utilities – infrastructure and process/system projects (e.g. facility expansion or redesign, new equipment or systems) including analysis, design and

implementation. Oversees and manages major improvement studies. Manage projects from concept development through qualification completion.

******************************************************************************** Jobs that Crossed My Desk Through April 12, 2015

*************************************************************************************** Recent listings for California at BIO.org http://jobs.bio.org/jobseeker/job/23029839/Quality%20Assurance%20Development,%20Principal%20Specialist/__company__/?keywords=California&vnet=0&max=25

Advanced Endoscopist, Division of Gastroenterology and Hepatology, Department of Medicine (Posted on 04/02/2015)

Stanford University (Stanford, CA )

Junior Specialist - Cell and Developmental Biology - Molecular and Cell Biology (Posted on 04/02/2015)

University of California, Berkeley (Berkeley, CA )

**************************************************************************** From ScienceJobs.org I’ve listed jobs from April, 2015

Life Sciences Postdoctoral Fellow (NIM1502.15) (Posted on 04/10/2015)

Palo Alto Veterans Institute for Research (PAVIR)

(Palo Alto, CA )

California Institute for Water Resources Coordinator (Posted on 04/03/2015)

UC, Ag & Natural Resources (Davis, CA )

Chief Software Architect/Project Manager (Posted on 04/11/2015)

University of California, San Diego (San Diego, CA )

Neurosurgery Nurse Practitioner

(Posted on 04/11/2015)

University of California, San Diego

(San Diego, CA )

Life Sciences Postdoctoral Fellow (NIM1504.15) (Posted on 03/11/2015)

Palo Alto Veterans Institute for Research (PAVIR) (Palo Alto, CA )

Lecturer in Public Health: Summer 2015 (Posted on 04/07/2015)

University of California, Merced (Merced, CA )

5/3/2015 20

Associate Specialist - Department of Chemical and Biomolecular Engineering (Posted on 04/06/2015)

University of California, Berkeley (Berkeley, CA )

Temecula Multispecialty Clinic CNII-Supervisor (Posted on 04/04/2015)

University of California, San Diego (San Diego, CA )

Sulpizio CVC PTU Per Diem RN

(Posted on 04/04/2015)

University of California, San Diego

(San Diego, CA )

Hillcrest OR CNII (Posted on 04/04/2015)

University of California, San Diego (San Diego, CA )

House Supervisor, Admin Nurse II-Supv (Posted on 04/04/2015)

University of California, San Diego (San Diego, CA )

Sr. Nursing Aid (Posted on 04/03/2015)

University of California, San Diego (San Diego, CA )

Ophthalmic Technician (Posted on 04/03/2015)

University of California, San Diego (San Diego, CA )

Patient Escort (Posted on 04/03/2015)

University of California, San Diego (San Diego, CA )

Postdoctoral Scholar-Department of Nutritional Sciences and Toxicology (Posted on 04/03/2015)

University of California, Berkeley

(Berkeley, CA )

Section Chief, Gastroenterology and Hepatology, Department of Medicine

(Posted on 04/02/2015)

Stanford University

(Palo Alto, CA )

Advanced Endoscopist, Division of Gastroenterology and Hepatology, Department of Medicine

(Posted on 04/02/2015)

Stanford University (Stanford, CA )

Junior Specialist - Cell and Developmental Biology - Molecular and Cell Biology (Posted on 04/02/2015)

University of California, Berkeley (Berkeley, CA )

*********************************************************************************** Our startups and affiliates (QB3) are hiring. See selected openings below. We maintain current job listings at http://jobs.qb3.org/. Applicants should direct inquiries, along with current CVs, regarding this posting to the following email address: nsigal@tunitastherapeutics.com. Research Associate: Cell Biology, Tunitas Therapeutics Tunitas Therapeutics is a privately held biopharmaceutical company that is poised to develop unique and precisely targeted protein therapeutics that will dramatically change the lives of allergy sufferers. Tunitas’ technology targets the IgE receptor on basophils and mast cells, the primary cellular mediators of allergic disease. By actively turning off signaling through the IgE receptor, this therapeutic approach has the potential to impact the lives of all allergy sufferers, particularly individuals with asthma and food allergy. Position Summary We are seeking a highly motivated Research Associate to join our team. This individual will play a key role in characterizing novel fusion proteins using a range of cell-based assays and employing both primary cells and cell lines. The assays will target allergic pathways, using a variety of readout technologies. In addition, he/she will assist in other aspects of recombinant protein production including transient transfections and establishment of stable cell lines. The

5/3/2015 21

candidate must be able to work independently and perform experiments to a very high standard, troubleshoot technical and scientific problems and effectively progress multiple projects simultaneously. This position requires strong scientific knowledge of current cell biology and molecular biology methods. The ideal candidate will be detail oriented, with excellent lab skills and maintain meticulous records. Requirements BS or MS in immunology or cell biology with 3-5 years of experience. • Experience with cell-based assay development for functional characterization of recombinant proteins • Experience with generation maintenance and characterization of novel cell lines • Experience with flow cytometry for characterization of rare cell populations • Experience with ELISA, histamine or cytokine release assays • Experience with standard molecular biology techniques • Experience with SOPs a plus • Can effectively analyze experimental data and present data at internal meetings • Maintains familiarity with current scientific literature and implements new techniques and technologies as appropriate _________________________________________________________________________ Research Associates (multiple), GALT GALT is hiring Research Associates with microbiology and molecular biology experience to help develop methods for high-throughput microbial cultivation, domestication, and screening. The Research Associate will join the Microbiology team, which supports the company’s mission of developing next generation high throughput microbiology automation equipment. At GALT, the Research Associate will work together with other scientists, including systems engineers and surface chemists, to develop protocols for high-throughput environmental microbe isolation, cultivation and screening. *Immediate responsibilities include: - Applying a range of analytical methods to characterize environmental samples, including PCR, qPCR, gel electrophoresis, spectrophotometry, and other plate assays - Building DNA libraries for NGS and Sanger sequencing - Using software tools for DNA analysis (QIIME, greengenes, BLAST) - Culturing a variety of microbes (aerobes, anaerobes, autotrophs, heterotrophs) using liquid and solid media - Supporting the development of new equipment for high throughput microbial testing, screening, isolation, domestication, and cultivation - Preparing materials including media and buffers, managing experimental schedules and processes, collecting/quantifying/analyzing/presenting experimental results - Communicating experimental results to team members and team leads The Microbiology team is integral to the design of systems that will increase accessibility to environmental organisms compared to conventional methods. Members of the Microbiology team need to have experience conducting microbial/molecular experiments, be creative, organized, energetic, collaborative, and be fully engaged in the execution of experiments. We need team members who are passionate about microbial prospecting and excited to develop new methods and protocols for the field. *QUALIFICATIONS/EXPERIENCE? We favor candidates with substantial experience designing and executing experiments in a lab setting: MS with 2+ years of working experience, or a BS with 4+ years working experience. We are interested in candidates with technical training in microbiology, molecular biology, and biochemistry. Lastly, we are looking for candidates with a history of high achievement in technical and non-technical work. ***RAs MUST have experience with NGS and microbial cultivation*** Send applications to leah@galt-inc.com. _________________________________________________________________________ Senior Scientist – Microbiology, Bell Biosystems Company Purpose Bell Biosystems, Inc. (www.bellbiosystems.com) is a life science startup company based in Mission Bay, San Francisco that is combining synthetic biology, cell biology, molecular and medical imaging to create disruptive products for

5/3/2015 22

regenerative medicine, oncology and other cell-based technologies. Our first-in-class product, the Magnelle®, is derived from a non-pathogenic bacteria that produces magnetic nanoparticles from intracellular iron. This provides researchers the unprecedented ability to track transplanted cells in vivo using non-invasive MRI. We are seeking a highly motivated scientist to join our team and participate in the effort to further develop our technologies. Responsibilities Overview • Demonstrate scientific leadership and innovation in furthering the development of our Magnelles for imaging and cell tracking applications • Develop improved methods for labeling eukaryotic host cells with Magnelles, utilizing techniques such as enhanced phagocytosis, microinjection, liposome-mediated transfection, and others • Utilize methods of recombinogenic engineering and directed evolution to optimize Magnelles for optimal function within the intracellular environment • Establish and functionalize microbial strains in-house to use as the basis for additional products. Minimum Qualifications • MD or PhD in microbiology, molecular biology, synthetic biology or equivalent, with broad knowledge of intracellular pathogens, artificial endosymbionts, and broad-based genetic engineering techniques • Minimum of 5 years of post-doctoral experience with proven high-impact achievements, industry experience highly preferred • Demonstrated background culturing difficult bacteria and mammalian cells • Excellence with standard molecular biology techniques such as DNA and RNA purification, PCR, qPCR, gene cloning, western blotting, fluorescence microscopy, and flow cytometry • Skilled in construction of gene cluster plasmids and conjugative transfer • Experience in process development is desirable • Successful track record of publication and scientific presentation • Experience managing small scientific teams is preferred Personal Characteristics • High level of accuracy and attention to detail • Excellent problem solving skills and focus on process-driven results • Excellent time management and organizational skills and ability to handle multiple projects simultaneously • Ability to thrive both individually and in a team environment to achieve business goals • Comfortable working with collaborators in academia and industry • Excellent communication and interpersonal skills What We Offer • Excellent startup team in result driven environment • Opportunity to develop our innovative discovery into viable products • Comprehensive benefits package and equity commensurate with compensation Being a game-changer isn’t easy. It requires personal initiative without micromanaging. You’ll probably work longer hours than your last 9-to-5 job, but your responsibilities will be fluid and you’ll have the satisfaction of helping build something meaningful and huge from the ground up. If this fits with your career goals and you and want to play an essential role in an aggressive biotech startup, please send your CV and cover letter to: HR@bellbiosystems.com. Please include “Senior Scientist - Microbiology” in the subject line of your e-mail. _________________________________________________________________________ Lead R&D Formulation Chemist, Acne.org POSITION TITLE: Lead R&D Formulation Chemist/Product Development Chemist KEY DETAILS: 6-month contract with possibility of subsequent, ongoing work. LOCATION: San Francisco, California POSITION OVERVIEW: The Lead R&D Formulation Chemist will be responsible for leading the technical development of OTC pharmaceutical-

5/3/2015 23

grade skincare product formulations from the drawing board to the laboratory and be able to work under limited supervision. The Lead R&D Formulation Chemist should exhibit theoretical creativity and laboratory expertise, and possess the ability to work alongside non-scientific peers to achieve our ambitious goals. DUTIES AND RESPONSIBILITIES: • Concept to launch development of mass-market OTC topical pharmaceutical products. • Be creative: translate new product ideas into formulations that will be loved by customers. • Keep an organized work plan to ensure work is never delayed due to lack of equipment or materials. • Produce new prototype samples rapidly and precisely. • Work and communicate effectively in a cross-functional team: take instruction from the executive team and make your own contributions. • Thrive in an entrepreneurial environment with aggressive deadlines and intellectual freedom. QUALIFICATIONS: • You may be up to the task if this describes your background in Chemistry, Chemical Engineering, or a related field: • PhD and 1+ years industry experience • Masters and 3+ years industry experience • Bachelors and 5-10+ years industry experience • Other experience that qualifies you as an expert in formulation chemistry • Understand the relevance of your academic research experience to formulation chemistry. • Experience in formulation of lotions, creams, gels, and cleansers. • Strong theoretical knowledge of colloids, surfaces, emulsions, and rheology. • Masterful bench skills. You are rigorous and methodical in your lab practices to ensure your work is always reproducible. • Knowledge of acne literature a plus. • Can-do, positive attitude. COMPENSATION: • Competitive compensation commensurate with experience. TO APPLY: • Please submit a cover letter and resume/CV to humanresources@acne.org _________________________________________________________________________ Senior Scientist - Protein Expression, GigaGen GigaGen seeks a talented, highly motivated PhD-level Senior Scientist to work alongside the Director of R&D and our R&D team on research funded by a Phase I SBIR grant from the NIAID. The candidate will assist in the design of a flexible protein expression system that will enable scFv and full-length antibody protein production on a massively parallel scale. Critically, we are developing production strains and workflows for high-yield polyclonal antibody production. In later 2015, we expect that the Phase II project will involve preclinical development of a polyclonal recombinant antibody product for treatment of immune deficiencies. One or more of the following specific skills could be useful: - Deep understanding of standard genomics and molecular biology techniques, such as subcloning, multiplex PCR, and next-generation sequencing. - Experience with antibody affinity screening methods, such as yeast cell surface expression or phage display. - Knowledge of production cell genetics, with particular attention to strain engineering and protein production optimization. - Hands-on experience with immune repertoire sequencing, RNA-Seq, sequencing library quality control, and next-generation sequencing instrumentation. - Excellent writing and presentation skills. - Experience, desire, and/or interest in drug discovery and development, with a particular focus on biologics. -------------------------------------------------------------------------------- Senior Scientist - Microfluidics, GigaGen

5/3/2015 24

GigaGen seeks a talented, highly motivated PhD-level Senior Scientist to work alongside the Director of R&D and our R&D team on research funded by a Phase I SBIR grant from the NCI. The candidate will assist in the design of an ultra high-throughput microfluidic system for generation of DNA libraries from single B cells. Critically, we are improving our current platform for 10x faster throughput. In later 2015, we expect that the Phase II project will involve preclinical development of a polyclonal recombinant antibody product for treatment of immune deficiencies. One or more of the following specific skills could be useful: - Deep knowledge of droplet microfluidics, with particular skills in prototyping and testing. - Understanding of standard genomics and molecular biology techniques, such as subcloning, multiplex PCR, and next-generation sequencing. - Excellent writing and presentation skills. Experience with writing patent disclosures a plus. - Experience, desire, and/or interest in drug discovery and development, with a particular focus on biologics. Email applications to djohnson@gigagen.com. _________________________________________________________________________ Nodexus is commercializing a novel microfluidic platform to provide fast, accurate, multi-parametric results. The Nodexus technology can count, size, and characterize particles, and the versatility of the platform makes it broadly applicable for use in several fields in the biomedical space and beyond. www.nodexus.com Senior Scientist, Cell Biologist, & Lab Manager, Nodexus We are seeking a seasoned cell biologist who will excel in the exciting, multidisciplinary environment of an early-stage Angel-funded startup company. This position will be responsible for experimental design, laboratory management, and will lead the testing of the flagship Nodexus particle screening platform. Position Overview • Experimental design • Lead platform testing • Lab management Position Requirements and Skills • M.S. plus 5+ years industry experience or Ph.D. in cell/molecular biology, bioengineering or related field with relevant post-graduate research experience and industry experience. • Extensive experience with mammalian cell culture, flow cytometry, genomic analysis, and general wet lab skills. • In addition to deep technical skills, successful candidates demonstrate strong organizational, communication and team skills, and thrive in a fast-paced start-up environment. • Proficiency in use of flow cytometers, FACS instruments, immunohistochemistry, confocal microscopy, common biological laboratory assays, cell culture management, and expert familiarity with experimental and testing design. • Experience with existing flow-based analysis and sorting technologies. The Ideal Applicant Will Be • Excited to work in an Angel-funded, early-stage company • Able to work 5+ days/week (as needed); Immediate start date preferred • Extremely motivated and be willing to work in a fast-paced environment, and with a hard-working team • Committed and enthusiastic about Nodexus’ mission and programs • Resourceful and flexible • Open to self-management and reporting • Able to demonstrate previous experience with delivering successful products under-budget and within established timelines • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused • Straightforward, self-motivated, and genuine

5/3/2015 25

-------------------------------------------------------------------------------- Senior Scientist, Microfluidics, Nodexus We are seeking a seasoned microfluidic specialist who will excel in the multidisciplinary environment of an early-stage Angel-funded startup company. This position will support the development of several aspects of the flagship Nodexus particle screening platform. Position Overview • Microfluidic device design and development Position Requirements and Skills • M.S. plus 8+ years industry experience or Ph.D. plus 5+ years industry experience in Bio/medical Engineering, Bio-MEMS, microfluidics engineering or related field with relevant post-graduate research experience and industry experience. • Extensive experience with microfluidic materials, design, and manufacturing. • In addition to deep technical skills, successful candidates demonstrate strong organizational, communication and team skills, and thrive in a fast-paced start-up environment. • Proficiency in use of CAD software and other Bio-MEMS design and simulation software. • Experience with a wide variety of Fluidic devices (e.g. flow cells and other microfluidic systems), preferential cell sorting, sample preparation techniques, and manipulation and filtration of cells in microfluidic formats. • Expert familiarity with existing flow-based analysis and sorting technologies. The Ideal Applicant Will Be • Excited to work in an Angel-funded, early-stage company • Able to work 5+ days/week (as needed); Immediate start date preferred • Extremely motivated and be willing to work in a fast-paced environment, and with a hard-working team • Committed and enthusiastic about Nodexus’ mission and programs • Resourceful and flexible • Open to self-management and reporting • Able to demonstrate previous experience with delivering successful products under-budget and within established timelines • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused • Straightforward, self-motivated, and genuine Send applications to vinny@nodexus.com. ************************************************************************************* https://jobs.smartbrief.com/action/listing?listingid=5B94BC6B-6B96-4925-A165-EDA7BBA3B547&briefid=263a5f36-

6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary

Date Posted:

3/31/15

Location:

Santa Ana, CA

Years Experience:

5+ in medical device development experience

Product Development Manager, Disposable Medical Products

ASAHI INTECC, Orange County CA R&D Center

Job Description

Job Title: Catheter Engineer

5/3/2015 26

ASAHI INTECC develops and supplies wire materials and products to the industries inside and outside Japan using an

integrated in-house production system based on our four advanced core technologies that covers everything from selection and treatment of raw materials to manufacture of final products.

In the medical field, ASAHI INTECC develops and manufacturers Asahi brand cardiovascular products such as PTCA guidewires, Guide catheter, PTCA balloon catheter, as well as OEM products, some of which have become world standards.

At ASAHI INTECC our mission is to create products that perfectly match the vision of each customer. That commitment is reflected in each strand of ultra-fine wirerope that we create and each of the final products that we manufacture.

[JOB Description]

This position is responsible for designing, developing, and commercializing vascular catheter.

[Your responsibility includes]

Design, development and prototyping of vascular catheters.

Design a manufacturing processes and technologies including bonding, joining, welding, braiding, coiling, plastics laminating.

All research and development activities for catheter development including making a prototyping, prototype product testing.

Working on product documentation including DHFs, drawings, test protocols etc..

Leading teams from conception through commercial launch of medical devices by developing design and process failure mode & effects documents.

Working with Design Engineers and Quality Engineers to successfully transfer new products into production and manufacturing.

[Requirement]

BS or MS Degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering or related Engineering Field.

* 3+ years of neurovascular / cardiovascular / endovascular medical device industry experience developing catheter or catheter based medical device.

Strong understanding of CAD and Computer Aided Design tools

Experience working within FDA, ISO guidelines (Design Controls) and compliance with internal Quality Systems.

[Benefit]

401K with company matching

Group Medical Insurance

Paid holidays, sick and vacation time

************************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=1BA411DF-0A2A-4AA4-88C9-

03C4A3CC3722&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief Job Summary Date Posted: 4/7/15

Location: Santa Clara, CA

Salary Range:

5/3/2015 27

Open

Years Experience: 8

Clinical Affairs Risk Management Scientist - 15000003AA

Abbott

Job Description

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship. Follow us on LinkedIn Primary Job Function: Provides scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies. Writes/manages clinical evaluation plans or clinical trial protocols, protocol amendments, clinical study project timelines and scientific publications. Interacts with various study support groups in order to assist in clinical strategy, the development of plans, reports and project deliverables. Interacts with regulatory agencies as needed, and will use their scientific knowledge in order to provide directives to staff as well as study sites. Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. · Facilitates communication between key stakeholders such as Sales and Marketing, R&D, Regulatory Affairs, PPG, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff. · Manages project timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. · Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. · Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. · Writes clinical evaluation plans, study protocols, protocol amendments, informed consents, reports and scientific papers for publication by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice. · Interprets results in preparation for product applications by evaluating clinical and scientific data and literature, and staying abreast of current clinical practice. · Presents scientific data by communicating accurate, succinct summaries of clinical results at industry gatherings, investigational meetings and regulatory agency meetings. Position Accountability / Scope:

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Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently. Plans and organizes project assignments of substantial variety and complexity. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives. Minimum Education: Bachelor's degree required, advanced degree preferred (MD or Ph.D.). Degree in the sciences, medicine, or similar discipline highly preferred. Minimum of 8+years of related work experience with a complete understanding of specified functional area, or an equivalent combination of education and work experience. Minimum Experience / Training Required: Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Experience with ISU's (Instructions for Use). Seeking experience in Clinical Development, Clinical Research, Study protocols and/or in risk management.

************************************************************************************* Our startups and affiliates are hiring. See selected openings below. We maintain current job listings at http://jobs.qb3.org/. Please send your resume to careers@nanoprecisionmedical.com with "Laboratory/Process Technician" in the subject line. This position is to be filled ASAP. No submissions will be accepted after 5/1/2015. If you would like to post an opening on our website, please contact us with your name, email address, and company name. We will forward this to VentureLoop, the third party who manages our job listings. They will contact you and set you up with access to a free account so you can manage your own posting details. Customer Support Associate, Blueprint Genetics Blueprint Genetics is a sequencing technology and genetic information company. This academic spin-off company was founded in 2012. We have further developed a Stanford University innovation called oligonucleotide-selective sequencing, OS-Seq, which represents the most effective targeted sequencing strategy in the market (Myllykangas et al 2011, Nature Biotechnology). Blueprint Genetics has harnessed this technology together with our in house built bioinformatics to produce comprehensive and high quality genetic diagnostics tools for clinical diagnostics market. The headquarters of the company are in Helsinki, Finland. We are now in the process of expanding our global sales to the United States and we have opened an office in San Francisco. We are an enthusiastic and ambitious team of biologists, physicians, bioinformaticians, geneticists, sales and lab personnel aiming to change the standards of genetic diagnostics. We are now building the US operations and the team to expand our services in North America. We are looking for an intelligent, organized, creative, social, proactive, well-written person to fill our Customer Support Associate position. In this job, one of the main tasks will be customer support therefore we are looking for a personality who enjoys customer service and has the essential social and communication skills to succeed in this position. You will also have a supportive role for our US sales team and the General Manager of US organization. You will be responsible for handling the diagnostic sample flow coming through our US office. We receive samples from Monday to Saturday. In this position you will take part in building and organizing the US operation. Your Primary activities will include

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- Provide customer support through phone and email. - Handle the diagnostic sample flow – will require Saturday duty when expecting sample deliveries. - Provide support for the sales team - helping schedule and plan meetings and travel for our sales team; assist email and mail campaigns. - Assist invoicing and reimbursement procedures. - Planning, organizing, and executing events, seminars, and other activities. - Assisting our team in planning internal and external company events with customers, collaborators and investors. Required Skills: - Customer service personality. - Excellent listening, oral, and written skills – it is all about communication. - Good organizational skills. - Energy and enthusiasm helps to survive in a start-up environment. - Ability to plan and organize simple to complex events. - Comfortable working in a fast-paced, small team environment. - Excellent time management and prioritization. Education/experience: - 1-2 years of Office management experience in a fast-paced environment. - Any customer support experience is considered beneficial. - Background in science - preferably life science is helpful in a genetic diagnostics company. - A bachelor's degree is preferred. _________________________________________________________________________ Formulation Scientist, ZoneOne Pharma ZoneOne Pharma is developing nano-chelation technologies for orphan drug disorders. Our primary focus is iron-overload. Additional programs involve partnerships with pharmaceutical companies or government agencies. ZoneOne Pharma is looking for a highly motivated Formulation Scientist with experience in liposome formulation and characterization. Experience with scale-up, GMP manufacturing and GLP analysis (HPLC) is a plus. The ideal candidate is high-energy, self-motivated and innovative. M.S or Ph.D. in chemistry, physical chemistry, chemical engineering, pharmaceutical sciences or related fields preferred. Division of time and duties: Laboratory Work 80%: Laboratory Work is defined as general wet lab procedures including: ● Preparation of liposomes: development of novel liposome formulations, preparation of liposomes for characterization, preparation of liposomes for evaluation in storage, cell culture studies, and animal studies. ● Characterization of liposomes: analysis of drug and lipid content, determination of size and zeta potential, analysis of targeting ligand density. ● Analytical method development: design, test and validate new HPLC methods. ● Evaluation of liposomes: stability in storage and in plasma, performance in cell culture studies including cell binding/accumulation and cytotoxicity, performance in animal models including plasma/tissue analysis. ● Formulation scale-up: assess and optimize process conditions for scale-up manufacturing of Z1P’s lead liposomal drug product (Z-204) to support key preclinical toxicology and efficacy studies. Aid in design and preparation of CMC documentation. ● Stability Studies: conduct drug product stability studies on Z-204 and other prototype formulations. ● Cell Culture: maintain cell lines in culture, perform in vitro studies. Lab Support 10%: ● Batch Records: Write batch records for API, excipients and processes used in liposomal formulation development. ● Notebooks: Keep up to date and signed record of all, rationale, experimental procedures and results. ● Process Data: Work up data from laboratory procedures into a format that can be shared in a report or presentation form. ● Analyze and interpret data: Present your conclusions on the meaning of results obtained in your studies. Scientific Research Support 10% ● Literature search and reading.

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Please submit CV to info@zoneonepharma.com. _________________________________________________________________________ Laboratory/Process Technician at Nano Precision Medical Nano Precision Medical is a start-up medical device company located in Emeryville, CA. We are developing a small, implantable device to improve treatment for people suffering from chronic diseases by providing sustained medication levels over several months without the need for injections. Job description: We are seeking a Laboratory/Process Technician who will help manufacture the next generation of drug delivery device in our development manufacturing facility. As a Laboratory/Process Technician, your primary duties will include: • Following procedures to produce and test parts as part of a development manufacturing line. • Keeping detailed electronic and/or written records of process and test results. • At times, evaluating and giving feedback to engineering staff on new process development. • Working with engineering staff on developing new documentation on process developments. • Maintaining and troubleshooting test apparatus and manufacturing fixtures. • Candidates must be comfortable working in a laboratory environment and be familiar with good laboratory practices (GLP) as well as be able to work independently while multi-tasking in a fast paced environment. Minimum Qualifications: • 1-3 years of experience in a biomedical or medical device company. • Experience with Microsoft Excel, Word, and general computing. • Demonstrated ability to work well with others in a team environment. • Ability to follow written procedures or verbal instruction. • Desire to contribute proactively to a constant improvement effort. Desired Qualifications: • Bachelor’s degree in STEM-related field. • Experience with experimental design. Our mailing address is: QB3 UCSF MC2522 1700 4th St., Byers Hall, Suite 214 San Francisco, CA 94158 USA ************************************************************************************ If interested please apply online and send me a copy of your resume to behzad.behrooz@spnc.com I'm in search for a great ME with 5-8 years work experience. For more detail you can check careers tab on www.spectranetics.com

***************************************************************************** https://jobs.smartbrief.com/action/listing?listingid=5BBF0141-AA19-47EC-910C-33EE48F1BF1A&briefid=263a5f36-6763-46c7-b399-4428c3a9fd06&sid=2c27e8c7-b8c8-41a0-9df0-199b99dc80c0&utm_source=brief

Job Summary Date Posted: 3/25/15 Location: Santa Clara, CA

Salary Range: Competitive

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Years Experience: 10 years

This Job appears in

AdvaMed SmartBrief

Compliance Director

Abbott Laboratories

Job Description

Description – External

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Primary Job Function

Provides direct oversight for Abbott’s ethics and compliance program at Abbott Vascular.

Responsible for directing the development and implementation of Office of Ethics and Compliance (OEC) policies and procedures, education and training, compliance monitoring and risk assessments. Regularly communicates with division management on the state of the compliance program and partners to develop action plans to manage compliance risks.

Core Job Responsibilities

Provide leadership, guidance, and support to all levels of divisional business functions on highly complex ethics and compliance issues, including policy interpretation, compliance risk assessment, trend analysis and best practice recommendations. Resolves highly complex ethics and compliance matters that have significant and possibly material impact to Abbott.

- Directs and conducts periodic reviews and updates to OEC policies and divisional procedures, ensuring clarity, applicability and alignment with higher level policies and external requirements, with minimal supervision from the Ethics and Compliance Officer.

- Develops, implements, delivers, and updates OEC’s comprehensive training program on complex divisional policies and procedures.

- Provides oversight to corporate and/or divisional monitoring process to ensure compliance with OEC policies and procedures. Reviews industry trends and internal monitoring results to recommend corrective actions.

- Partners with the Ethics and Compliance Officer and business on compliance audits, oversees the fulfillment of auditor’s requests, acts as liaison between the business and auditors during on-site activities, evaluates and responds to all preliminary findings and recommendations, and guides the business in preparing corrective actions to address all findings and recommendations.

- Oversees the Compliance Review Committee at the divisional level and provides input on handling violations. Reviews internal trends and implements corrective actions.

- Provides leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with the Legal Department, as appropriate, to propose solutions to the business.

- Possesses in-depth knowledge of Abbott’s businesses and knowledge of the broader business impact.

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- Leads highly complex cross-functional teams.

This position has direct report(s), so there is an emphasis on people management, including mentoring, coaching, and developing direct reports and others on the team.

- Also plays a key role in selecting, recruiting, and developing team members.

- Assists the Ethics and Compliance Officer in succession planning for the department.

Position Accountability/Scope

- Accountable to the Ethics and Compliance Officer.

- Assigned matters / division(s) have significant and possibly material impact to Abbotts’s compliance program.

- Operates with autonomy and limited supervision.

- Provides guidance and direction to Coordinators, Compliance Analysts, and Compliance Managers, as needed.

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Other Information for Those in Transition ************************************************************************* *********************************************************************** 32 Biotech and Pharma Recruiters at Source: http://www.genengnews.com/insight-and-intelligence/32-biotech-and-biopharma-recruiters/77900088/?page=1 ************************************************************************ 4 Expert Tips on Writing a Resume for Biotech Industry, Nov 25, 2013 by Clinovo Read at

http://blog.clinovo.com/4-expert-tips-on-writing-a-resume-for-the-biotech-industry/

See article entitled “6 Ways to Crack the Hidden Job Market” about cracking the hidden job market where 80% of jobs are found. The article was written by Nancy Collamer, M.S., is a career coach, speaker and author of Second-Act Careers: 50+ Ways to Profit From Your Passions During Semi-Retirement. Her website isMyLifestyleCareer.com; on Twitter she is @NancyCollamer. http://www.forbes.com/sites/nextavenue/2013/08/12/6-ways-to-crack-the-hidden-job-market/2/ ******************************************************************** Nice piece on informational interviews by Susan Oct. 22, 2012 at Work Coach Cafe at http://www.workcoachcafe.com/2012/10/22/how-to-do-successful-information-interviews/

Thanks to Paula Rutledge for sharing. ***************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2012 on the biotechnology industry at www.ey.com. This is the 26th anniversary issue using consistent

measures to track the industry sector. http://www.ey.com/Publication/vwLUAssets/Beyond_borders_2012/$FILE/Beyond_borders_2012.pdf See Beyond Borders Matters of Evidence 2013 biotechnology report at

http://www.ey.com/Publication/vwLUAssets/Beyond_borders/$FILE/Beyond_borders.pdf See most recent Beyond borders: unlocking value Global biotechnology report 2014 At http://www.ey.com/GL/en/Industries/Life-Sciences/EY-beyond-borders-unlocking-value

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

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.

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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

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.

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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. 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

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

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/

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