Senior Scientist - Cell Therapy Product Characterization
Core
Lead the development and execution of potency methods to characterize the function and mechanism of action of cell therapy products, integrating process and product data to define critical quality attributes.
Role type
Senior Scientist (Cell Therapy Product Characterization)
Builds
Potency assays, analytical methods, and data-driven quality strategies for cell therapy products.
Domain
Biotechnology / Cell Therapy
Required skills
Potency method development, Multicolor flow cytometry, T-cell biology, Genetic engineering technologies, Experimental design, Data analysis, Regulatory reporting, Technical writing, Cross-functional collaboration, Mentoring
Preferred skills
Python programming, AI-assisted development, Data automation, Statistical software, Spectral or imaging flow cytometry, Assay multiplexing
Technologies
Python, Statistical software, Data repositories, Spectral flow cytometry, Imaging flow cytometry
Responsibilities
Develop and execute potency methods for cell therapy characterization; Define critical quality attributes and product characterization strategies; Implement new analytical technologies for cell health and function; Integrate process and product data to identify trends; Develop automated data workflows and dashboards; Partner with process development to link parameters to quality; Investigate out-of-specification lots; Author method development and regulatory reports; Mentor junior scientists.
Seniority
Senior, hands-on IC with leadership responsibilities