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Senior Coordinator, QC Stability

JOB SUMMARY:    The Senior Coordinator, QC Stability will lead QC activities associated for the day-to-day coordination and execution of the stability program at Sangamo. The coordinator will be responsible for maintaining all program inventories and supporting documentation required to conduct Emergent stability studies in a complaint manner. The position will also support GMP 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 also support management of the Company's designated Contract Testing Organizations (CTOs).   FUNCTIONS:  Implement and maintain a GMP compliant stability program including protocol writing, stability planning and set-up, stability sample inventory and distribution for testing, stability report writing, and stability data trending. Write and revise standard operating procedures as needed. Monitor stability equipment and coordinate with other groups to ensure all equipment is maintained in a calibrated and qualified state. Regularly monitor stability sample inventory. Ensure that the stability program is compliant with GMP, ICH and other appropriate regulatory guidance. Accurately track and maintain outstanding stability data throughout the testing lifecycle and ensure that scheduled testing is initiated within the scheduled test period. Independently maintain sample inventory/disposition database including reconciling inventories. Plan and execute QC stability testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete  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 Support oversight of QC activities at CTOs, including the review 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 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 Minimum of 7 years of experience in the biotechnology or pharma industry with a primary focus on stability for biologic products or MS with 5 years' experience Skills and knowledge of implementing and managing a compliant stability program. Organizational skills and be detail oriented and able to manage multiple projects. In-depth experience of QC stability testing and regulatory/pharmacopeia requirements OTHER REQUIREMENTS: Experience of QC release testing and characterization of Ideal candidate will have laboratory skills that include compendial testing such as appearance and fill volume, container closure integrity testing, and simple analytical instrumentation. Knowledge of Good Manufacturing Practices and Good Laboratory Practices. Experience with HPLC, GC, UV, sub-visible particle analysis, and IR a plus. Solid communication and presentation skills required. Previous experience with viral vector-based, cell-based products and cell bank stability is preferred. Experience of managing CMO/CTO relationships and projects Sound understanding and demonstrated application of statistical methods/tools Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills Ability to operate in a fast-paced, multi-disciplinary industrial environment   Sangamo is an equal opportunity employer 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, Stability, Quality Control
Salary Range: NA
Minimum Qualification
8 - 10 years

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