Principal Scientist, Analytical Development

About the Role

• Onsite (South San Francisco, CA). Principal Scientist, Potency; reports to Sr. Director, Head of Molecular and Potency Method Development.

• Develop and qualify pivotal stage potency, immunoassay, and other cell-based methods to support characterization, process development, release, and stability testing.
• Follow ICH and internal Method Development guidance to develop robust analytical methods (including measuring residual impurities) for intermediates and drug substances/products.
• Create product characterization strategies and methodologies for the pipeline.
• Develop and execute methods to implement control strategies for gene and cell therapy products.
• Document experimental procedures/results in ELN; complete required notebook review/approval.
• Present results and communicate with cross-functional technical, analytical, and biological stakeholders.
• Serve as a subject matter expert for potency/immunoassay/cell-based methods.
• Draft/review/approve technical documents (Test Methods, SOPs, Development/Technical Reports, study plans).
• Calibrate, maintain, troubleshoot, and qualify instruments/reagents; maintain reagent inventory and improve lab efficiency.
• Support Quality Control on method transfer, qualification, and testing at CDMOs and internally.
• Resolve development obstacles via creative solutions, collaboration, and problem-solving.

• PhD with 8+ years or MS with 10+ years industry experience.
• Deep expertise in pluripotent stem cell or stem cell-derived drug products.
• Experience developing/qualifying late-stage potency methods for pluripotent stem cell or stem cell-derived pancreatic islet cell products (FDA/ICH/USP).
• Proficient independent data analysis using JMP or other statistical software; draw conclusions and recommend next steps.
• Experience with pCQA assessment and specification setting.
• Strong Microsoft Office; experience with data analysis tools (e.g., JMP, Soft Max Pro) and Smartsheet.
• Mammalian cell culture and aseptic generation of cell stocks.

• Statistical software (JMP) for DOE, visualization, and analysis.
• Analytical method development for pivotal/commercial cell therapeutics; familiarity with FDA/ICH and GxP.
• Experience partnering with Quality Control for GMP testing and method transfer.
• Self-motivated, accountable, critical thinking, troubleshooting/problem-solving; multitasking and effective communication.
• Managing direct reports.