Senior Manager of Quality Control 1194992
Job Scope & Purpose:
Our client is an innovator in the Cell Therapy space looking to add a Senior Manager of Quality Control. The ideal candidate will oversee QC testing to support clinical phase cell therapy product releases associated stability programs. This position requires expertise in activities related to a start-up and implementation of an in-house QC laboratory and laboratory program.
Primary Job Responsibilities:
- Building the Quality Control unit, including integrating high-quality talent capable of developing and executing in-house analytical and environmental testing
- Establish laboratory procedures for standard reference management, sample management and storage, environmental monitoring program, and other appropriate robust programs and procedures, as necessary
- Establish a microbiological program, including testing for endotoxin, bioburden, sterility, microbial ID testing, raw materials, water, and environmental monitoring
- Provide technical and operational expertise for training, product investigations, deviations, change controls, CAPA, and quality improvements to ensure product quality is met consistently
- Contribute to appropriate sections of IND and BLA filings
Primary Job Requirements:
- BS or MS with 7+ years of biopharmaceutical industry experience, including 4 years in an analytical testing laboratory and supervisory experience
- Experience in execution, assessment, and troubleshooting flow cytometry
- Experience with cell and gene therapy products
- Experience in establishing Quality Control laboratories
- Experience in regulatory inspections and clinical and commercial phase cell and gene therapy QC related regulations
- Previous history managing relationships with internal departments, external vendors, and partners
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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