Senior Scientist, Drug Product Analytical Science (ASAT), Cell Therapy
Core
Technical expert supporting the Cellular Therapy product portfolio by designing, executing, and analyzing experiments in bioassay, flow cytometry, and molecular biology for QC investigations and method validation.
Role type
Senior Scientist, Drug Product Analytical Science (Cell Therapy)
Builds
QC analytical methods, validated test protocols, and regulatory submissions for cell therapy drug products.
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
Bioassay design and execution, Flow cytometry, Molecular biology, Analytical method lifecycle management, cGMP regulations, Technical writing, Regulatory submission authoring, Root cause analysis
Preferred skills
Advanced degree, Experience in gene therapy or viral vectors, Cross-functional collaboration
Technologies
Bioassay platforms, Flow cytometry instruments, Molecular biology tools (lentiviral, AAV vectors)
Responsibilities
Design 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 experimental findings to the team and support regulatory inspections.
Seniority
Senior, hands-on IC
