Lead Analyst, Quality Control (Product Testing)
Core
Perform analytical testing and support lot release activities for biopharmaceutical products in the Biochemistry QC Lab.
Role type
Senior IC Quality Control Analyst (Biopharmaceuticals)
Builds
Final product, in-process, and stability samples
Domain
Life Sciences / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical testing, cGMP compliance, data integrity, SOP execution, method validation, OOS investigation, equipment qualification, reagent preparation, troubleshooting
Preferred skills
ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency assays, physicochemical assays
Technologies
ELISA, PCR, CE, SDS-PAGE, IEF/icIEF
Responsibilities
Prioritize and perform analytical testing to meet business timelines; Test final product, in-process, and stability samples per SOPs and methods; Document and review results in compliance with cGMP and data integrity requirements; Execute methods such as ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, potency, and other physicochemical assays; Support general lab operations: housekeeping, equipment upkeep, inventory, autoclaving, and glassware management; Prepare and maintain standards/reagents based on GMP requirements; Troubleshoot analytical methods and equipment issues; Participate in equipment qualification and maintenance; Support or lead OOS and deviation investigations; draft reports; Train others on test methods; Contribute to method transfer and validation activities; Author change controls, test methods, and SOPs
Seniority
Senior, hands-on IC
