SDRAN posts job applications for Regulatory positions for firms in the San Diego County area only.
We do not accept postings from recruiters. Postings will remain on the website for approximately 30 days.
To place a job posting, please send a brief description of the position (200 words or less) with contact information to
Greg Payne - SDRAN Communications & Membership at gpayne1@cox.net

NAMSA

Quality Assurance Manager (6/09/2009) NAMSA, the world leader in medical device testing has an immediate opening for a Quality Assurance Manager. Responsibilities: Oversight of the GLP/GMP quality assurance function for a single location, including staffing, budgeting, and training Serves as the management representative for ISO 13485 and Quality System Regulation (QSR) Will be the primary interface for regulatory agencies for regulatory audits and submissions Responsible for hosting client audits Qualifications: Bachelor's degree in a scientific discipline Minimum of 5 years quality experience, including 2 years management experience Must have a working knowledge of 21 CFR 211, 21 CFR 820, 21 CFR 58, and ISO 13485; knowledge of ISO 17025 is preferred Applying Interested candidates please e-mail resume to: HR@namsa.com

Product Development Management Association (PDMA)

PDMA Job Search Program (6/03/2009) A program on job searching that will be held June 16 at UCI. PDMA is also offering a discounted registration fee for those who are unemployed. Please refer to the URL below for additional details. http://pdma.org/chapter_events_detail.cfm?pk_event=335

Integra LifeSciences Corporation

Regulatory Affairs/Compliance Specialist (5/27/2009) Integra LifeSciences Corporation is a leader in developing and marketing innovative devices and products for use in neurosurgery, reconstructive surgery, and soft tissue repair. Our growing company is seeking an accomplished professional committed to taking us to higher levels of growth and innovation. This position is located at our San Diego, CA facility. Responsibilities: Manage the Risk Management process for site, including drafting of health hazard assessments and related activities Review Engineering Change Orders for Regulatory function Manage updates and translations for Instructions For Use(IFU) and labels Act as Alternate Management Representative for FDA and Notified Body in EU Maintenance of Technical files and Declarations of Conformity for CE Marking Responsible for preparing, distributing and maintaining the Quality Department's metrics for the complaint and CAPA processes Supports the preparation of the metrics and data for the QMR Skills: Concentrated knowledge of U.S., EC & Canada regulatory submission requirements (510(k)s, Design Dossiers) Strong knowledge of FDA QSR, ISO 13485:2003 & Health Canada Excellent communication, writing and team-building skills Experience: Bachelor's Degree in science or engineering or equivalent work experience 5+ years in medical device industry and 2 in RA or Compliance preferred 2+ years in interpretation and application of standards, guidances, laws and regulations 2+ years in assisting in preparation of FDA submissions preferred Applying: Please apply on our website at: www.integra-ls.com/home/careers/currentopenings.aspx

MicroVention

Regulatory Affairs Project Manager (5/12/2009) MicroVention is a rapidly growing medical device company that is pioneering the development of catheter-based technologies for the endovascular treatment of peripheral and cerebral vascular diseases. Scope Assists the Director, RA with management of regulatory submissions and compliance programs for new products on a world-wide basis. Responsibilities: Plays a key role in the preparation of regulatory submissions (e.g. 510(k)s, Design Dossiers; potentially IDEs and PMAs) for intravascular, catheter- based products Participates in hosting outside regulatory bodies during plant inspections Skills: Concentrated knowledge of U.S., EC & Canada regulatory submission requirements (510(k)s, Design Dossiers) Strong knowledge of FDA QSR, ISO 13485:2003 & Health Canada Excellent communication, writing and team-building skills Requisite Experience: BA/BS in Science, Engineering or Medical Technology Five to seven years experience in Regulatory Affairs Strong knowledge of Regulatory submission and compliance requirements for the US, Canada, European, and other international markets, for sterile, intravascular catheters and implants Applying: Please email resume in MS Word format to hr@microvention.com or fax resume to 949.362.0968, Attn: HR Department. Thank You! We are proud of our diverse environment, EOE, M/F/D/V. MicroVention, Inc. is an equal opportunity employer.

PrideStaff

Regulatory Affairs Compliance Specialist (5/11/2009) Job Duties: Responsible for supporting all regulatory activities Prepare and compile regulatory submissions for the company's products Responsible for filing necessary applications and handling government interactions pertaining to the regulation process for medical devices requiring governmental approval Maintain FDA and device listings and establishment registration Maintain FDA and device listings and establishment registration Prepare and coordinate activities related to 510k's, pre-market notifications Participate in and assist with FDA facility inspections, Notified Body Audits and other governmental inspections as directed Participate in the review of product labeling, promotional materials and product modifications Review product incident reports and prepare and submit medical device and adverse event reports as required to applicable regulatory bodies Prepare tables, charts, graphs and other documents as necessary Coordinate annual product testing and facility audits Requirements: At least two plus years of experience working for a medical device company in regulatory affairs Must have a strong knowledge of FDA regulations regarding medical devices Bachelor's degree is a plus Strong written and oral communication skills Strong word processing and database skills Applying: Qualified candidates, please email your resume for immediate consideration to carlsbad@pridestaff.com This position does have an option to be direct hire. Salary is $45,000 - $50,000 DOE.

Cougar Biotechnology

Sr. Manager, Regulatory Operations (5/04/2009) Job Summary: The Senior Manager, Regulatory Operations represents Regulatory Operations on regulatory project teams, serves as a primary contact to the FDA and other regulatory authorities related to regulatory submissions, and is primarily responsible for managing project deliverables and resources to meet Regulatory Affairs departmental goals. This position sSupports submission of Regulatory documents including the planning, scheduling and coordinating of Regulatory submissions and Safety reporting developments, based upon thorough knowledge of applicable regulations for electronic submissions and company procedures. Qualifications: The successful candidate will have a Bachelors degree in a scientific discipline, or systems technology or equivalent; knowledge of US and Global requirements with regard to submission content and format; proficiency in the use of Adobe Professional and specialty document publishing tools;, and advanced eCTD publishing experience. In addition, the candidate must posses three (3) to five (5) years of drug development/regulatory experience. Knowledge in the compliant use of an enterprise-wide EDMS and managing teams of 2 or more is strongly preferred. Applying: Email resume to recruiting@cougarbiotechnology.com Include PR117 in the subject line We are not accepting resumes from recruiters at this time; candidates only

Simply Biotech

Regulatory Affairs Manager (5/04/2009) We are seeking a Regulatory Affairs Manager for a leading device firm in Orange County. In this role, the RA Manager will be responsible for overseeing the regulatory submissions associated with new and revised designs. Duties: Manage the regulatory submissions including 510(k)s, Technical Files for CE marking, Canadian Medical Device Registrations files, Japanese PAL submissions, and Australian TGA submissions Provide documentation in support of country specific product registrations as well as FDA registrations and listings Oversee device tracking orders and post market requirements as required for product approvals Assist with development of project plans for new product introductions and modifications to existing devices as an integral part of the Design Team Partner with Marketing and Clinical Support on labeling and advertising development and approval The qualified Regulatory Affairs Manager will possess: Bachelor's degree (Biological or Engineering preferred) 3+ years' medical device experience with Class II and/or Class III devices including a recent successful submissions track record An understanding of US Quality Systems Requirements for Medical Devices and CE marking requirements for EU. Understanding of Canadian, Australian and Japan Medical Device regulations desired Applying For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call 858.487.0507 More informatin can be found at www.simplybiotech.com

Accumetrics

Quality Control Supervisor (4/30/2009) Accumetrics is a privately held company that is committed to advancing medical understanding of blood platelets and enhancing quality of care for patients at a risk of cardiovascular disease by providing industry-leading diagnostic tests for platelet function assessment. We are growing and recognize that talented and motivated people working together is the key to our success and growth. We have an exciting opportunity for a Quality Control Supervisor. Reference Job Code 13 LL. Job Summary: In this position, you will supervise the activities, manpower and resources within the Quality Control group to ensure support is provided to meet the department and company goals. Areas of responsibility include: raw material inspections, in-process testing and finished goods inspection for both instrument and in vitro diagnostic products. Requirements: Bachelor degree in life science, chemical engineer or equivalent Minimum of 5 years of experience in Quality Control, QSR/ISO 13485 and FDA regulations in Medical Devices Minimum of 2 years of supervisory experience Minimum of 2 years of experience in statistical analysis and process control Certification in 6 sigma or Lean MFG preferred Come be a part of the team at Accumetrics and see your career grow. We are located in the Sorrento Valley area and offer great benefits with competitive salaries and a challenging, pleasant work environment. Please forward your resume and salary history to: jobs@accumetrics.com Reference 13 LL.

Quality Assurance Manager (4/27/2009) Accumetrics is a privately held company that is committed to advancing medical understanding of blood platelets and enhancing quality of care for patients at a risk of cardiovascular disease by providing industry-leading diagnostic tests for platelet function assessment. We are growing and recognize that talented and motivated people working together is the key to our success and growth. We have an exciting opportunity for a Quality Assurance Manager (Job Code 12 SS). Job Summary: In this role you will be responsible for providing support in the overall development, implementation, maintenance and performance of the Quality System. You will provide assistance with the customer complaint activity, internal and external audit program, CAPA program, Training program and preparation for ISO certification. Requirements: BS degree in a scientific discipline, engineering or other technical related field Minimum of 5 years of work experience in Quality Assurance in a FDA regulated environment in Medical Device or Diagnostic Demonstrated track record of success with improvement and maintenance of quality systems Experience in working in a collaborative team environment Come be a part of the team at Accumetrics and see your career grow. We are located in the Sorrento Valley area and offer great benefits and a challenging, pleasant work environment. Please forward your resume and salary history to: jobs@accumetrics.com Reference Job Code 12 SS.

Heidelberg Engineering

Manager/Director Regulatory Affairs and Corporate Compliance (4/20/2009) Heidelberg Engineering is a leading developer of laser scanning and imaging devices for identifying and tracking eye disease. We have been a pioneer in developing new analytical approaches for detecting and managing glaucoma as well as diseases of the retina and cornea. The company’s core technologies include confocal microscopy, scanning lasers and optics, optical coherence tomography and software image analysis. Our company places a strong emphasis on people, products, and process to continue driving our success. We are searching for a Manager/Director Regulatory Affairs and Corporate Compliance. This person will be responsible for regulatory submissions to FDA and international agencies for medical device clearance, approval and/or licensing as well as for clinical studies related to device. This position will work closely with others to prepare submissions for new products and product changes as required to ensure timely approval for market release and interface with multiple functional areas, geographies and divisions within the company. This position will serve ESSENTIAL DUTIES AND RESPONSIBILITIES: Prepares reviews and submits necessary regulatory information to FDA to obtain 510(k) clearance and PMA approval of products Coordinates with various functional areas in the preparation, review and submission of IDE applications for clinical studies, as well as other clinical studies including marketing studies Reviews all submissions to FDA and international agencies for completeness, truthfulness and compliance with regulations Serves as the primary contact to FDA for review of submissions to FDA Keeps up-to-date on proposed regulations and guidelines published by FDA and international agencies Reviews advertising and promotional material and device labeling for regulatory compliance Controls the introduction of product through the United States market through management of the release approval process Initiates changes to practices and procedures to support compliance requirements Brings regulatory and corporate compliance questions/issues to the attention of senior management Provides general guidance or training support of professional staff Provides interpretations & direction to applicable company personnel regarding the regulatory aspects associated with relevant functions Acts as Corporate Compliance Officer to review, audit and ensure compliance with corporate compliance policies and procedures KNOWLEDGE/SKILLS/ABILITIES REQUIRED: BS/BA in scientific or engineering discipline or equivalent combination of education and experience. MS or JD preferred 10-15 years of successful experience in related field and successful demonstration of increasing responsibility and accomplishment in the responsibilities described above A thorough knowledge of U.S. FDA regulatory laws and requirements to ensure compliance to regulations and an understanding of regulatory laws in major international markets High levels of professionalism, ethics and compliance in order to interact with FDA and serve as a representative of Heidelberg Engineering Strong written and oral communication skills in order to facilitate communications with FDA Advanced degree may be substituted for experience, where applicable Approximately 20% of time may require domestic and/or international travel German language ability a plus Interested candidates please forward current resumes directly to: Alda Jorgenson Recruiter Heidelberg Engineering ajorg@roadrunner.com www.HeidelbergEngineering.com

Kaz, Inc.

Quality / Regulatory Engineer (4/15/2009) Kaz, Inc., is a world leader in the manufacture of medical thermometers, blood pressure monitors, heating pads, as well as other home comfort products such as portable air cleaners, humidifiers, heaters, fans, lawn & garden. Kaz markets products under the Vicks, Honeywell, Braun, and other brands. Visit our website at www.kaz.com. Kaz.Inc. is looking for a Quality / Regulatory Engineer for a small R&D division developing exciting medical devices in San Diego, CA. It is the best of both worlds: a small, empowered R&D team working within a stable, well established company that designs and markets consumer healthcare products. DUTIES/RESPONSIBILITIES: Assist in writing design input specifications and design documentation for new medical devices Participate in phased Design Reviews Write product qualification test protocols and reports, traceability matrices, product quality test plans Provide robust linkage between design inputs, risk level, and reliability requirements for design outputs Participate in brainstorming sessions Ensure accurate and complete Design History Files and Master Records Perform internal quality and design control audits Perform medical product risk analysis, including hazard analysis Implement and maintain GCP and FDA QSR compliance (especially Design Controls), compile CE Technical File per European Medical Device Directives, and work on other global regulatory compliance Work with contract manufacturers to ensure that design history and related documentation is correctly and completely transferred and manufacturing documentation is compliant with regulations Manage clinical trials of medical devices Assist in preparing 510K submissions Interface with other division in the company to ensure good oral and written communication JOB REQUIREMENTS: BS degree in a technical discipline with a minimum of 5 years QA / regulatory experience in medical product development Self starter, flexible and motivated Excellent verbal and written communication skills Knowledge of statistical sampling and analysis Proficiency in MS Office Suite Some domestic travel required Apply to: Hiring Organization: HR Kaz, Inc. Send resumes to: resumes@kaz.com

Biosite/Inverness Medical Innovations, Inc.

Regulatory Affairs Manager (4/15/2009) The qualified candidate will work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for international and domestic product registrations, permits and licenses. Assists in the evaluation of change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc. Participates on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, corrective/preventive action, audits, training, recalls/field corrective actions, MDR/MDV, etc.). TASKS/RESPONSIBILITIES: Participates on product project teams with responsibility for determination of regulatory submission needs, proposal of regulatory strategy, and preparation of documentation for international and domestic new product registrations permits and licenses Interfaces with state, federal, international regulatory agencies as well as international distributors regarding registrations and licenses Participates on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, corrective/preventive action, audits, recalls/field corrective actions, MDR/MDV, etc.) Ensures compliance to all relevant regulatory requirements and standards Ensures product technical files, documentation and relevant clinical/scientific literature are maintained and periodically updated as required Generates/revises documentation and data necessary for department operations (e.g. SOPs, forms, tables, records, reports, meeting summaries, etc.) Evaluate change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc. Additional projects as required Travel to company affiliates, industry conferences/meetings or external training events may occur as required POSITION REQUIREMENTS: Minimum bachelor's degree (BS/BA) in any biological science (or equivalent combination education and/or work experience) with 3+ years> regulatory experience in a medical device or IVD manufacturing environment Strong knowledge of quality systems in a manufacturing environment; working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of IVDs and medical devices Preference given to those with IVD experience especially in the cardiovascular or home-testing markets, and/or to those with demonstrated CLIA waiver experience. Ability to work cohesively with multi-disciplinary scientific working groups and regulatory agencies Apply to: Keith Jerbasi Sr. Talent Acquisition Specialist Talent Acquistion - North America Biosite/Inverness Medical Innovations, Inc. Tel: 858-805-2829 Fax: 858-695-8589 kjerbasi@biosite.com www.biosite.apply2jobs.com

Heidelberg Engineering

Director Clincial Affairs and Medical Education (Opthamology) (4/13/09) Heidelberg Engineering is a leading developer of laser scanning and imaging devices for identifying and tracking eye disease. We have been a pioneer in developing new analytical approaches for detecting and managing glaucoma as well as diseases of the retina and cornea. The company’s core technologies include confocal microscopy, scanning lasers and optics, optical coherence tomography and software image analysis. Our company places a strong emphasis on people, products, and process to continue driving our success. We are searching for a Director of Clinical Affairs & Medical Education with research experience in ophthalmology who is able to bridge good science to product development and product marketing. Previous clinical research experience in a university or industry setting is required. The Director is responsible for being the principal medical advisor to the company, including our headquarters in Heidelberg, Germany, providing review and medical input into the development, marketing, clinical testing and regulation of the company’s products. The Director will interface with key functions including R&D, marketing, and regulatory affairs in addition to outside parties such as regulatory agencies, the media and the medical community on matters of medical expertise. Essential Duties and Responsibilities: Serve as key medical advisor to the management staff and Company, contributing to the training, leadership and continuing education for all company staff Oversee Medical Education and Clinical Applications Support Staff; assist in evaluating and assuring rapid response and world class best practices for customer support Lead the development and implementation of clinical strategies in support of the company’s marketing and business growth strategy Supervise and implement clinical trials and clinical evaluation of products, in the context of data needed, for product development, product testing or regulatory required information, meeting aggressive timelines and budget Partner with project teams, other product development groups and the marketing function to define the requirements and specifications for new products, and to develop new product ideas and concepts Serve as an authoritative resource for clinical personnel seeking expert opinion or clinical references for the use and interpretation of Heidelberg Engineering products Review Company-provided medical information and content for accuracy, general clinical acceptance, and supporting evidence; including product labeling (user manuals and guides), marketing materials, selected published literature and website content Assist in the preparation and writing of regulatory filings Interface with key opinion leaders and key personnel in medical societies and other professionals of importance to the business Provide expert review and input for any company required regulatory reporting and/or customer complaints where medical expertise is required Provides medical and specialty expertise for safety surveillance of clinical studies Assist in the training and education of the sales and marketing staff Work closely with marketing and education staff to perform pre-launch market development activities to gain clinical experience with products prior to market introduction Review clinical literature for relevance to product development and marketing activities. Attend appropriate scientific meetings to maintain awareness of research activities in area of expertise Provide practical working knowledge of current socioeconomic, ethical, legal, and regulatory trends in health care and physician practice Knowledge/Skills/Abilities Required: MD, MD/PhD or PhD degree, preferably with specialty training in ophthalmology Minimum of five years of clinical research experience or two years of applicable industry experience in a biotechnology or pharmaceutical company in a similar position Demonstrated experience in successfully leading clinical development of drug or device products pre-clinical activities through clinical trials and successful product approval(s) Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines and interpretation/evaluation of clinical data Knowledge of US regulatory process Strong management skills; decisive; resourceful Well developed interpersonal skills; strong in providing education on complex scientific/clinical issues in a crisp and clear manner both to a peer and larger audience Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment Demonstrated leadership experience, including excellent analytical, planning, and communication skills in a dynamic environment Track record of recruiting and developing high performing clinical staff and to take on increasing responsibility in a high growth environment Excellent verbal and written communication skills, public speaking and teaching skills, working knowledge of Microsoft Office required Maturity, confidence and credibility to advise and influence senior management Willingness to travel approximately 40%+ of time, including international Knowledge/Skills/Abilities Required: Interested candidates please forward current resumes directly to: Karen Wise Recruiter Heidelberg Engineering wisejobs@cox.net www.HeidelbergEngineering.com

Simply Biotech

Regulatory Affairs Specialist - IVD (4/06/09) Position Summary: We are seeking a Regulatory Affairs Specialist with a strong IVD background for a growing national firm. In this role, the RA Specialist will join the IVD team in performing a variety of submission related activities for the firm's clients. This is a fast-paced position with a very flexible and lifestyle-oriented firm. This is an exciting opportunity for an RA Specialist with In Vitro Diagnostics regulatory experience who enjoys a challenging experiences and a diverse workload. This is a growth position and it is expected that this person will gain the experience necessary to lead project teams. In this role, the RA Specialist will work primarily in San Diego and the position will require very light travel (likely less than 10%). The qualified Regulatory Affairs Specialist will possess: Bachelors Degree 1+ year IVD Regulatory Experience Excellent written and oral communication skills Submission Experience Online submission experience a plus To Apply For This Position: This company offers exceptional pay, bonuses, and benefits For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call (858) 487-0507 More information can be found at www.simplybiotech.com

Regulatory Affairs Generalist (4/06/09) Position Summary: We are seeking a Regulatory Affairs Specialist with a diverse background across several therapeutic areas for a growing national firm. In this role, the RA Generalist will work on a multiple project teams in performing a variety of submission related activities for the firm's clients. This is a fast-paced position with a very flexible and lifestyle-oriented firm. This is an exciting opportunity for an RA professional with broad regulatory submission experience who enjoys a challenging experiences and a diverse workload. This is a growth position and it is expected that this person will gain the experience necessary to lead project teams. In this role, the RA Generalist will work primarily in San Diego and the position will require very light travel (likely less than 10%). The qualified Regulatory Affairs Generalist will possess: Bachelors Degree 4+ years Regulatory Submission Experience Excellent written and oral communication skills Online submission experience a plus To Apply For This Position: This company offers exceptional pay, bonuses, and benefits For immediate and confidential consideration, please email your resume to info@simplybiotech.com or call (858) 487-0507 More information can be found at www.simplybiotech.com

Halozyme Therapeutics, Inc.

Senior Director level Regulatory Affairs (3/18/09) Halozyme Therapeutics, Inc., a biopharmaceutical company that engages in the development and commercialization of products targeting the extracellular matrix for the drug delivery, oncology, and dermatology markets. Our portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Enhanze Technology is currently being developed in alliance partnerships with Hoffman La Roche and Baxter Bioscience. Our commercial product is HYLENEX for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. Hylenex is marketed in an alliance partnership by Baxter Medication Delivery. We are also developing additional products in the medical disciplines of oncology and dermatology. Position Summary: The Dir-Sr Director will be fully responsible for the development of efficient and effective regulatory strategies and in the prosecution of those strategies achieve commercial status and lifecycle management. Develop regulatory intelligence as the basis for the formulation of efficient and effective regulatory strategies with international scope Effective prosecution of the developed regulatory strategies Identify and implement tactics and positioning to achieve the earliest possible approvals of all regulatory submissions Represent the company as the primary therapeutic regulatory expert in corporate alliance team structures to facilitate the attainment of the corporate alliance objectives Direct and provide primary responsibility for the Interaction and negotiation with domestic and foreign regulatory agencies Coordinate, draft, prepare and submit regulatory applications and documents Take lead role in management of regulatory activities for key projects and coordinate filing efforts between corporate disciplines Identify and define key regulatory issues related to the pre-clinical and clinical development and manufacturing of products Assure compliance with U.S. and international regulations Qualifications: Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline. A higher degree (Masters, PhD) is preferred. RAC certification or equivalent Breadth of Regulatory Affairs experience in a biopharmaceutical company involved with development, manufacturing, testing and distributing ethical pharmaceutical products with at least five years in a management role Demonstrated leadership participation with U.S. and international submissions, a working knowledge of FDA/EMEA regulations, the regulators, and the approval process, and an excellent track record in building effective relationships with regulatory authorities Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the Company. Experienced in all components of regulatory submissions including Chemistry, Manufacturing and Control, non-clinical, and clinical documentation is further required A strong record of successful U.S. submissions for biologics and drugs which include INDs, NDAs, MAAs, Annual Reports, Amendments, Supplements, DMFs. Submission experience in oncology, dermatology, and matrix targeted therapeutics desired To Apply For This Position: Please send your resume to: hr@halozyme.com and reference job code 903-DK-DRA-SDRAN in the subject line. For more information on the company, visit our website at www.halozyme.com STOCK SYMBOL: HALO EOE.

Director Level Quality Assurance (3/18/09) Halozyme Therapeutics, Inc., a biopharmaceutical company that engages in the development and commercialization of products targeting the extracellular matrix for the drug delivery, oncology, and dermatology markets. Our portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Enhanze Technology is currently being developed in alliance partnerships with Hoffman La Roche and Baxter Bioscience. Our commercial product is HYLENEX for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. Hylenex is marketed in an alliance partnership by Baxter Medication Delivery. We are also developing additional products in the medical disciplines of oncology and dermatology. Position Summary: We are currently seeking Director level professionals in Quality Assurance to: Provide Quality Assurance leadership and support in drug substance and drug product clinical and commercial manufacturing for Halozyme products and Halozyme alliance partnership products Provide Quality Assurance leadership and support in the formulation and approval of Quality Agreements between Halozyme alliance partnerships and Halozyme CMO’s Provide Quality Assurance leadership in the development of CMC sections for new IND/IMPD’s and annual reporting Provide Quality Assurance leadership in the conduct, analysis and reporting of clinical supply and commercial product stability programs Provide Quality Assurance liaison to alliance partnerships in cGMP policies, practices, with CMO’s and release drug substance and drug product for clinical trials and commercial products Ensure efficient, effective, robust documentation systems to maintain cGMP compliance for change control, batch records, specifications, analytical and process validation, release tests, and stability programs Develop and oversee a training program for cGMP and quality related issues Review and analyze internal data to detect trends and ensure product quality; lead periodic management quality review meetings Interact with internal and external clients on matters relating to product quality Provide Quality Assurance liaison for regulatory agency pre-approval and periodic audits Qualifications: Bachelor’s Degree in chemistry or science; Masters or PhD in chemistry, biochemistry is strongly preferred Hands-on QA management experience in the biotechnology industry, including recombinant biotechnology protein manufacturing, FDA/EU regulatory environment, and knowledge of QA paradigms, cGMP’s, ICH regulations, eCTD CMC content and format, analytical method validation To Apply For This Position: Please send your resume to: hr@halozyme.com and reference job code 812-DK-DQA-SDRAN in the subject line. For more information on the company, visit our website at www.halozyme.com STOCK SYMBOL: HALO EOE.