Principal Scientist, Analytical Development

Role: Principal Scientist, Potency at Sana Biotechnology, leading or supporting development of potency and cell-based analytical methods for cell therapy products. Objectives: enable characterization, process development, release testing, and stability assessment of pluripotent stem cell-derived therapeutics, ensuring compliance with regulatory guidelines. Responsibilities: develop and qualify assays (immunoassays, cell-based methods), transfer and qualify methods for GMP testing, create detailed documentation, support quality control and method transfer at CDMOs, and serve as subject matter expert. Qualifications: PhD with 8+ years or MS with 10+ years industry experience; deep expertise in pluripotent stem cell or stem cell-derived drug products; experience in developing potency methods for late-stage cell therapies per FDA, ICH, USP standards; proficiency in data analysis software like JMP; hands-on mammalian cell culture skills. High-Value: focus on pluripotent stem cell therapeutics, late-stage (preclinical/IND), GxP/ GMP compliance, quality control, and assay development. Work setup: onsite in South San Francisco, CA; potential exposure to BSL2 biohazard materials; may require occasional off-hours.