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. Responsibilities 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. Qualifications & Skills 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, SoftMax Pro) and Smartsheet. Mammalian cell culture and aseptic generation of cell stocks. Preferred/Additional 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. #J-18808-Ljbffr Scorpion Therapeutics