Senior Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Core
Senior Scientist leading the lifecycle of bioassay methods for cell therapy drug products, including design, execution, validation, and transfer of QC analytical methods.
Role type
Senior Scientist, Drug Product Analytical Science (Cell Therapy)
Builds
QC analytical methods and bioassays for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Analytical Science
Required skills
Bioassay design and execution, Cell-based potency assays, Reporter gene assays, Cell counting, Method validation and transfer, Technical writing (SOPs, reports), Regulatory guideline knowledge (FDA, EMA, ICH, USP, EP), Laboratory troubleshooting, Experimental design
Preferred skills
Flow cytometry, Molecular biology, GMP environment experience, Lentiviral/AAV vector experience
Technologies
Bioassay platforms, Flow cytometers, Molecular biology instruments
Responsibilities
Design and execute laboratory experiments for bioassay optimization and validation, Support root cause analysis and corrective actions for assay performance, Author and review technical documents including test methods and investigation reports, Present findings to teams and support regulatory submissions, Train and mentor staff on cell biology techniques, Partner with development on method optimization
Seniority
Senior, hands-on IC