QC Manager - Covid-19 Vaccine
One of the most innovative biotechs in San Francisco is seeking a QC Manager to help implement a stability system from the ground-up!
This firm is one of the key players in Covid-19 vaccine development, and is looking to drastically increase headcount in the coming months. As they dive into 2020 their stock is projected to more than double as the company further establishes their dominance in the Bay Area.
The Manager of Quality Control will have the following responsibilities:
- Ensures contract laboratory and in-house cGMP and GLP compliance and adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of chemistry, method validation, and stability.
- Interact with customers, contract laboratories, auditors and regulatory agencies. Support agency and other third party inspections.
- Ensures current knowledge and implementation of FDA/ICH guidance documents and USP/EP requirements.
- Review and responds to third party customer audits.
- Review and approve raw material, finished product and stability test data generated in the Quality Control Laboratory
- Responsible for the timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP and GLP compliance, and attainment of operational and development goals.
The ideal candidate will have the following skill set:
- Bachelors at a minimum with 4+ years of senior-level QC experience
- Drug substance and/or drug product experience
- Experience overseeing vendors / contract sites