Sr QC Manager - Analytical Development
Sr QC Manager - Analytical Development
City of Hope
Duarte, CA
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The Analytical Development (AD) / Quality Control (QC) team at the Center for Bioinnovation and Manufacturing (CBM) seeks a Quality Control Manager to support analytical development for GMP Manufacturing and gene and cellular immunotherapy products. Responsibilities include managing AD/QC staff, developing analytical methods, generating SOPs, reviewing test results, consulting on product release strategies, overseeing lab operations, and providing validation support for laboratory equipment.
As a successful candidate, you will:
- Oversee analytical development and quality control (QC) activities to ensure GMP compliance for CBM products.
- Recruit, manage, and train QC staff for tasks in a cGMP facility.
- Review, revise, and develop standard operating procedures (SOPs) as needed.
- Establish and perform in-house assays for product release, including viral vectors, plasmid DNA, and recombinant proteins.
- Interact with internal and external testing service providers to ensure quality, and review and approve third-party assays.
- Maintain up-to-date knowledge of regulatory requirements, lab technologies, and attend relevant training and conferences.
- Master's degree in biochemistry, molecular biology, or related fields; Ph.D. preferred; 5 years of quality control/research experience with Ph.D. or 10 years with a Master's degree.
- Proficient in modern cell and molecular biology analytical methods (Q-PCR, capillary electrophoresis, FACS, ELISA, infectious titer assay, etc.); supervisory experience required.
- Biotechnology or pharmaceutical industry experience; experience in release testing for clinical trials and method development is highly desirable.
To learn more about our Comprehensive Benefits, please CLICK HERE.
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Seniority level
Not Applicable -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Hospitals and Health Care, Non-profit Organizations, and Research Services
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