The Cell Based Potency Scientist has the opportunity to drive our state-of-the-art potency assay development that supports the company’s portfolio of our client’s different clinical- stage cell and gene therapy products. We are recruiting a Scientist with experience in the development, optimization, and qualification of potency assays and characterization of cell and gene therapy products. S/he will work with a CBM analytical development team for rapid advancement of cellular therapy candidates from development through commercialization. The role requires a strong understanding of cell biology/immunology/molecular biology and expertise with the design and development of cell-based assays to assess protein function. The ideal candidate will be independent and detail oriented, have experience in design and development of novel functional cell-based assays, have a working knowledge of analytical guidelines and work collaboratively with cross functional teams, viz. discovery groups, process sciences groups, internal analytical functions, as well as with Manufacturing Sciences and the Quality Control organization.
- Develop, optimize, and qualify potency assays used for development, characterization, qualification of cell and gene therapy products and critical materials.
- Author and review SOPs, technical reports, and assist in the preparation of regulatory submissions.
- Contribute to technical transfer of analytical methods both internally and to external vendors by acting as an SME during the transfer of assays and providing technical troubleshooting support when needed.
- Work with cross-functional groups including Research & Development, QC, and Process Development.
- Participate in various aspects of method development, transfer, characterization, comparability, and investigation.
- Manage routine sample testing including the coordination of testing with Process Development, Research and Development groups, and external vendors.
- Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
- PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 0-2 years of R&D / analytical development experience or bachelor’s or master’s degree with 3-5 years of relevant experience.
- Strong background in cell culture and experience working with cell lines and primary human cells.
- Experience with mechanism of action, functional, or potency assay development.
- Broad experience with molecular biology, cellular, and immunoassay techniques including transfections/transductions, ddPCR/qPCR, ELISA.
- Experience using data analysis software including JMP and PLA software.
- Ability to critically think though experimental challenges and troubleshoot.
- Strong organizational skills and attention to detail.
- Excels at written and verbal communication.
- Knowledge of ICH/USP guidelines and experience with assay qualification/validation preferred.
- Experience with FACS is a plus.