Principal Scientist, Analytical Development
Sana Biotechnology, Inc.
August 20, 2026
On-site
South San Francisco, CA
Operations
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.
- 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.