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Infographic showing various Head Cell Culture job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution.

Principal Scientist, Analytical Development

South San Francisco, CA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

Other

Posted 11 days ago

Job description

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.

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