Principal Scientist, Analytical Development

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in South San Francisco, CA is seeking a Principal Scientist, Potency to lead analytical method development for potency, immunoassay, and cell-based assays supporting characterization and development of gene/cell therapies.

The role requires advanced degree with extensive industry experience in pluripotent stem cell products and hands-on data analysis (JMP, SoftMax Pro). You will collaborate across Technical and QA teams and mentor staff.

Qualifications

• PhD with 8+ years or MS with 10+ years of industry experience.
• Deep expertise in pluripotent stem cell or stem cell-derived products.
• Experience developing 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.

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.

Skills

PhD with 8+ years

MS with 10+ years

Stem cell potency methods

Data analysis (JMP)

pCQA assessment

Smartsheet

Cell culture (mammalian)

GMP/QC knowledge

Education

PhD

MS

Tools

JMP

SoftMax Pro

Smartsheet

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.