Senior Scientist, Drug Product Analytical Sciences (ASAT), Cell Therapy
Core
Technical expert designing and executing bioassay, flow cytometry, and molecular biology experiments for QC analytical methods in cell therapy drug products.
Role type
Senior Scientist, Drug Product Analytical Sciences (Cell Therapy)
Builds
QC analytical methods and data for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
Bioassay design and execution, Flow cytometry, Molecular biology, cGMP regulations, Analytical method lifecycle management, Technical writing, Regulatory submission support, Method validation and transfer
Preferred skills
Advanced degree, Experience in gene therapy or viral vectors
Technologies
Bioassay platforms, Flow cytometry instruments, Molecular biology tools
Responsibilities
Design, plan, and execute hands-on laboratory experiments for QC investigations; Develop and optimize laboratory methods and protocols; Author and review technical documents including SOPs and validation reports; Support method transfer and validation in compliance with global regulatory requirements; Lead CAPA and deviation investigation tasks; Train and mentor team members on cell biology and flow cytometry techniques; Present findings to the team and support regulatory submissions.
Seniority
Senior, hands-on IC