Lead Analyst, Quality Control (Chromatography)
Core
Perform analytical testing and support lot release activities for biopharmaceutical products in the Biochemistry Area.
Role type
Senior IC QC Analyst (Chromatography/Biochemistry)
Builds
Final product, in-process, and stability samples
Domain
Biopharmaceuticals / Life Sciences
Required skills
Analytical testing, SOP execution, cGMP compliance, data integrity, method troubleshooting, OOS investigation, method validation, change control authoring, lab operations management
Preferred skills
Biotech lab experience, FDA/EMEA/ICH guidelines knowledge, physicochemical assay expertise
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
