Senior Scientist, Analytical Sciences
Core
Develop and qualify cell-based analytical methods (bioassays, flow cytometry) for vector and cellular therapy products to support process development, characterization, and release testing.
Role type
Senior Scientist, Analytical Sciences (Cell Therapy)
Builds
Analytical control strategies and validated methods for novel engineered cell therapy platforms
Domain
Biotechnology / Cellular Therapy / Analytical Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cell culture, immunological techniques, multi-parametric flow cytometry, cell-based functional assays, QbD, DOE, T cell biology, cell signaling pathways, regulatory concepts (cGMP), data analysis software (Prism, JMP, FlowJo)
Preferred skills
multi-color flow cytometry (10+ colors), gap and risk assessments, statistical analysis
Technologies
FlowJo, CytEpert, SoftMax Pro, Prism, JMP
Responsibilities
Lead analytical method development team and review data; advance cell-based bioassay and immunophenotyping methods from conception to transfer; execute experimental study plans for cell therapy platforms; collaborate with Quality on technology transfers and validation protocols; write technical reports and CMC sections for regulatory submissions; maintain and operate analytical instrumentation.
Seniority
Senior, hands-on IC
