Senior Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Core
Senior Scientist leading bioassay methods (cell-based potency, reporter gene, cell counting) for cell therapy drug products in a regulated QC environment.
Role type
Senior IC analytical scientist (cell therapy bioassays)
Builds
QC analytical methods and bioassays for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Analytical Science
Required skills
cell-based potency assays, reporter gene assays, cell counting, flow cytometry, molecular biology, analytical method lifecycle management, method validation, method transfer, cGMP regulations, FDA/EMA/ICH/USP/EP guidelines, technical writing (SOPs, validation protocols), root cause analysis, CAPA, regulatory submission authoring
Preferred skills
gene delivery platforms (lentiviral, AAV), instrument operation and standardization, training in method execution
Technologies
bioassay platforms, flow cytometers, molecular biology instruments
Responsibilities
Design and execute laboratory experiments with appropriate controls; support method optimization, transfer, validation, and maintenance; lead CAPA and deviation investigations; author technical documents and regulatory sections; mentor staff on cell biology techniques; collaborate on development studies and reagent selection; present findings to the team.
Seniority
Senior, hands-on IC