The Scientific Expert / Senior Scientific Expert, Analytical Development (Cell-Based / Characterization Assays) will collaborate with the Century’s Research, Technology and Development teams in order to harness the power of adult stem cells to develop curative therapies for cancer. The incumbent’s key responsibilities will be developing, validating, and implementing analytical methods for the quality control of cell therapy products, ancillary materials, and excipients used in their production, and critical reagents used in testing. They will also support process and product characterization, specification setting, and drafting of regulatory submissions. This role will require extensive interaction with internal and external partners to leverage best-in-class expertise and capabilities in cell therapy analytical testing.
• This individual will be responsible for developing, validating, and instituting analytical methods for cell therapy products.
• This includes analytical methods for release, stability, and characterization of cell therapeutics, ancillary materials and excipients used in their production, and critical reagents used in testing.
• The role will work with external partners for access to expertise, technology, and capacity, help build internal expertise, and interact extensively with all functions within the internal team.
• Additional responsibilities will include participation on portfolio project teams as project lead and/or functional area expert.
• Travel up to 25%
• Ph.D. or M.S. in Biochemistry, Bioanalytics, or related life-sciences field
• +4 years (Ph.D.) /+8 years (M.S.) experience in a biologics or cell therapeutics development organization, with a thorough knowledge of the development process
• Expertise in cell therapeutic quality control methods development, validation, and implementation
• Experience with iPSCs or related cell therapy products is preferred
• Experience supporting regulatory submissions is desired
• Strong expertise in development, validation, and implementation of cell-based assays, flow cytometry, PCR, protein/vector assays, microarrays / MSD, ELISA, and microbiological testing for product quality control
• Robust working knowledge of cell therapy products and their associated regulatory standards, as well as related biotechnology products, ancillary materials, excipients, and reagents required for GMP manufacturing
• Experience managing relationships with external partners and suppliers
• Demonstrated ability to positively influence corporate culture, team dynamics, and influence scientific rigor and productivity