Specialist, Quality Control
Core
Execute cGMP QC testing for raw materials, drug substance, and finished products using cell-based potency assays, ELISA, and protein analysis; lead method transfers and qualification activities.
Role type
Senior IC Quality Control Specialist (Bioassay)
Builds
cGMP-compliant QC testing capabilities and reliable bioassay methods for mRNA medicines
Domain
Biopharmaceuticals / mRNA manufacturing / Bioassays
Required skills
cGMP laboratory operations, cell-based assays, ELISA, protein analysis, qPCR, sequencing, method validation, troubleshooting, SOP writing, data analysis, CAPA management, technical training
Preferred skills
Method development/qualification, aseptic techniques, laboratory instrumentation, equipment calibration, FDA/EU/ICH guidelines, technical writing
Technologies
qPCR, ELISA, Biological Safety Cabinets, pH meters, balances, pipettes
Responsibilities
Execute routine testing for release, stability, and in-process samples; lead method transfers and qualification activities; teach and train analysts on technical concepts and methods; write and revise SOPs, protocols, and reports; troubleshoot analytical methods and equipment; review analytical data and perform trending; manage quality records including investigations and CAPAs; maintain safe laboratory environment and support audits.
Seniority
Senior, hands-on IC