Principal Scientist, Analytical Development

Responsibilities

• Develop and qualify pivotal stage potency, immunoassay, and cell-based methods for cell therapy products
• Follow ICH and internal guidance to develop robust analytical methods for intermediates and drug products
• Develop product characterization strategies and methodologies to advance the pipeline
• Create detailed documentation of experimental procedures in electronic laboratory notebooks
• Serve as a subject matter expert on potency and immunoassay methods
• Draft and review technical documents including SOPs, Development Reports, and Technical Reports
• Support Quality Control on method transfer and qualification at CDMOs

Requirements

• PhD with 8+ years or MS with 10+ years of industry work experience
• Deep expertise in pluripotent stem cell or stem cell-derived drug products
• Experience developing late-stage potency methods per FDA, ICH, and USP guidelines
• Proficiency in data analysis using JMP or other statistical software
• Experience with pCQA assessment and specification setting
• Experience with mammalian cell culture and aseptic techniques

Preferred Qualifications

• Experience with DOE and data visualization in JMP
• Experience developing analytical methods for commercial phase cell-based therapeutics
• Familiarity with GxP principles and FDA/ICH guidelines
• Experience supporting GMP testing and method transfer with Quality Control
• Experience managing direct reports

About the Company

Sana Biotechnology is dedicated to developing engineered cells as medicines to meaningfully change the outcome of many human diseases.