Responsibilities

• Perform routine in-process and release QC testing of cell products.
• Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
• Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
• Track and test products according to stability protocols.
• Work with internal and external resources to maintain lab in an optimal state.
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
• Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.

Qualifications

Bachelor or Masters Degree

5+ Quality Control

GMP, SOPs, and QC Process

Experience in biotech and/or pharmaceutical