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SR QC MANAGER - ANALYTICAL DEVELOPMENT - 10025741
Duarte, CACity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
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.
Qualifications:
- 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.
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.
To learn more about our Comprehensive Benefits, pleaseCLICK HERE.