Position Summary
Senior Scientist (Technical expert) supporting the Cellular Therapy product portfolio; performs hands-on lab experiments supporting QC analytical methods using bioassay, flow cytometry, and/or molecular biology.
Duties/Responsibilities
- Provide bioassay/flow cytometry/molecular biology expertise for QC investigations, including root-cause analysis, CAPA, corrective/preventive actions, and bench studies.
- Design, plan, and independently execute experiments; analyze and document data; collaborate cross-functionally.
- Develop/optimize laboratory methods and protocols; present findings and progress updates.
- Support commercial method transfer and method validation per global regulatory requirements.
- Steward bioassay/flow cytometry/molecular methods; implement method lifecycle/maintenance programs.
- Author/revise/review technical documents (test methods, SOPs, trend/investigation reports).
- Lead project and investigation-related tasks and continuous improvement.
- Support regulatory submission analytical sections and respond to health authority questions; act as method validation/transfer expert during inspections as needed.
- Partner with development teams on qualification studies, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train/mentor others; foster a collaborative quality culture.
Qualifications
- Bachelorβs in a relevant scientific discipline required; advanced degree preferred.
- 8+ years relevant analytical experience (preferably GMP, cellular or gene therapy).
- Expertise in: bioassay (potency, reporter gene assays, cell counting); flow cytometry (instrument platforms, standardization, multiparameter, antibody titration); molecular biology (lentiviral/AAV and other gene delivery).
- Hands-on lab experience; analytical method lifecycle (transfer/validation/maintenance); cGMP/QC experience.
- Strong understanding of FDA/EMA/ICH/USP/EP for quality control of viral vectors, cell therapies, vaccines and/or biological products.
- Technical writing (SOPs, method validation protocols/reports); effective communication; travel required.
Benefits (explicit categories)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; financial well-being/protection (401(k), disability, life/accident, supplemental insurance, business travel protection, legal support).
- Paid time off (flexible time off/annual vacation depending on location/employee type).
Application Instruction
- Apply even if the role doesnβt fully match your resume.