Support the environmental monitoring and microbiology testing programs. Assist in method validation/qualification and commissioning activities and support contract labs.
- Manage microbiology and environmental monitoring of the manufacturing areas
- Handle in-process and lot testing
- Ensure timely review of EM data, microbiology testing data, and OOS reports and protocols
- Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
- Serve as a qualified trainer, provides guidance to other analysts
Education and Qualifications
- Bachelor's degree in Biology, Microbiology or related scientific field is required
- At least 5 years of cGMP Microbiology experience; cell therapy experience preferred
- High proficiency in aseptic techniques
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.), deviations, investigations, etc