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Director, Quality Control

LOCATION: This position will initially be located in our Point Richmond facility and then relocate to Brisbane.  We anticipate opening our Brisbane facility in late 2018 / early 2019.  There may be the opportunity to work in Brisbane in a temporary facility prior to completion of our new manufacturing facility.   JOB SUMMARY:    The Director Quality Control (QC) will lead QC activities associated with the GMP production and testing of the Company's products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and gene modified hematopoietic stem cells. This position will oversee the operation of the QC Chemistry and Stability, Bioassay, Microbiology, and Raw Material functions. These groups are responsible for supporting the QC testing, utility and environmental monitoring and overall support for clinical and commercial product manufacturing.  The director manages and develops QC staff (performance management, technical & leadership development and succession planning). The successful candidate will be responsible for overseeing QC activities at the Company's designated Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs).   FUNCTIONS:  Implement and manage a GMP compliant laboratory control program in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability Planning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete  Responsibility for release testing of raw materials, process intermediates, ancillary products, drug substances and drug products Define and implement environmental monitoring and personnel monitoring programs to ensure compliance to regulatory requirements Support CMO production activities by coordinating testing activities with appropriate external and in-house departments Support in-house production by co-ordination of in-process QC testing, environmental monitoring, and release/characterization testing with appropriate departments/CTOs Prepare specifications and Certificates of Analysis (COA) for QA review Establish and execute stability programs for raw materials, cell and viral banks, drug substances and drug products Coordinate with the Analytical Methods Development group the phase appropriate qualification/validation of analytical procedures, the transfer of such procedures into QC, and the setting of appropriate acceptance criteria Manage the development, validation, and approval of all microbiology, and raw materials test methods used in production operations as well as Assay Transfer with external customers or CMO/CTOs  Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs Draft and review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations Assist in the preparation of CMC regulatory submissions Interact with the FDA and other worldwide regulatory agencies, per product filings (IND, BLA MAA etc.), regarding any questions relating to microbiology, biochemistry, chemistry and stability testing  Other activities as may be assigned   EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:The ideal candidate for this position will have demonstrated in-depthexperience of establishing and managing QC functionsassociated with the GMP production and testing of biologic products in both clinical and commercial settings.Candidatemust possess: A BS in Biological Sciences, Bioengineering or Chemistry; MS or PhD preferred Minimum of 15 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic products Minimum of 10 years demonstrated track record of leadership and management of QC groups with people development and performance management skills In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validation   OTHER REQUIREMENTS: Experience of QC release testing and characterization of viral vector-based and cell-based products a plus Experience with the application of analytical techniques in a QC environment, including Compendial testing, Spectrometry, Chromatography, ELISA, Capillary Electrophoresis, Chip technology. DNA sequencing, Particle Analysis, Cell-based assays, Biointerferometry and FACS experience a plus. Experience with the set-up and operation of laboratories, bioburden control programs and data control and data integrity systems Experience of managing CMO/CTO relationships and projects Sound understanding and demonstrated application of statistical methods/tools In-depth knowledge of US and European Pharmacopeia methods and requirements In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA and WHO regulations a plus. Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills Ability to operate in a fast-paced, multi-disciplinary industrial environment   The above reflects management's definition of essential functions for this position, but does not restrict the tasks that may be assigned.The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.   Job Function Key Words:Biotechnology, Manufacturing, Quality Assurance
Salary Range: NA
Minimum Qualification
15+ years

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