Senior Scientist - Cell Therapy Product Characterization
Core
Lead product characterization and potency method development for cell therapy products, defining critical quality attributes and translating complex datasets into scientific recommendations.
Role type
Senior Scientist (Cell Therapy Product Characterization)
Builds
Potency assays, analytical methods, and data-driven quality strategies for cell therapy programs.
Domain
Biotechnology / Cell Therapy
Required skills
Potency method development, Multicolor flow cytometry, T-cell biology, Genetic engineering technologies, Experimental design, Data analysis, Regulatory documentation, Cross-functional collaboration, Technical leadership, SOP authoring
Preferred skills
Python programming, AI-assisted development, Data automation, Assay multiplexing, Spectral or imaging flow cytometry, Scientific publications/patents
Technologies
Python, Statistical software, Data repositories, Flow cytometry instruments
Responsibilities
Develop and execute potency methods to characterize cell therapy function; Define critical quality attributes and characterization strategies; Implement new analytical technologies for cell health and function; Integrate process and product data to identify trends; Build automated data workflows and dashboards; Partner with process development to link parameters to quality; Investigate out-of-specification lots; Author technical reports and regulatory filings; Mentor junior scientists.
Seniority
Senior, hands-on IC with mentorship responsibilities