Principal Scientist, Analytical Development

Sana Biotechnology•South San Francisco, CA

2h•$200,000 - $240,000•Onsite

About The Position

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Principal Scientist, Potency, you will report to the Sr. Director, Head of Molecular and Potency Method Development. You will either lead or support the development and implementation of potency, immunoassay, and other cell-based methods for Sana’s cell therapy products, and support method transfer and qualification to enable GMP testing. This role is onsite in South San Francisco, CA.

Requirements

PhD with 8+ years or MS with 10+ years industry work experience
Deep subject matter expertise in pluripotent stem cell or stem cell-derived drug products
Experience in developing and qualifying late-stage potency methods for pluripotent stem cell or stem cell-derived pancreatic islet cell products per FDA, ICH, and USP regulatory guidelines
Proficient in independently analyzing data using JMP or other statistical software, drawing conclusions, and making recommendations for next steps
Experience with pCQA assessment and specification setting strategies
Excellent skills in Microsoft Office, Smartsheet, data analysis software (e.g. JMP, SoftMax Pro), and other applications
Experience with performing mammalian cell culture and generating cell stocks using aseptic techniques

Nice To Haves

Experience using statistical software such as JMP for DOE, data visualization, and analysis
Experience with development of analytical methods for pivotal and commercial phase cell-based therapeutics
Familiarity with FDA and ICH guidelines and GxP principles
Experience working with Quality Control function to support GMP testing and method transfer
High degree of self-motivation, accountability, and ability to think critically and demonstrate troubleshooting and problem-solving skills
Ability to multitask, communicate effectively, and quickly adapt to changing business conditions
Demonstrate values like teamwork, integrity, accountability, and excellence
Demonstrate effective interpersonal and communication skills
Managing direct reports

Responsibilities

Act as a key contributor in developing and qualifying pivotal stage potency, immunoassay, and other cell-based methods to support the characterization, process development, release testing, and stability testing of cell therapy products
Follow ICH and internal Method Development Guidance Document to develop robust analytical methods for characterizing intermediates, drug substances/products and measuring residual impurities
Develop product characterization strategies and methodologies to advance Sana’s pipeline
Develop and execute methods to implement control strategies for gene and cell therapy products
Create detailed documentation of experimental procedures and results in the electronic laboratory notebook and complete the review and approval of notebook entries per established policy
Present results at group meetings and communicate effectively with a broad audience with a range of technical, analytical, and biological expertise
Serve as a subject matter expert on potency, immunoassay, and other cell-based methods
Draft, review, and/or approve technical documents (e.g., Test Methods, SOPs, Development Reports, and Technical Reports, and comprehensive study plans)
Perform calibration, maintenance, troubleshooting, and qualification of instruments and reagents
Maintain inventory of reagents and improve operational efficiency in the laboratory, adhering to laboratory safety standards
Contribute to best laboratory practices and keep pace with innovations
Support Quality Control on method transfer, qualification, and testing at CDMOs as well as internal laboratory operations and testing as needed
Overcome obstacles (time constraints, material limitations and instrumental capabilities) through creative solutions, collaboration and problem solving