About the roleSana 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.
What you'll do- 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
What we're looking for- 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
What will separate you from the crowd- 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
What you should know- There may be potential exposure to BSL2 and BSL2+ biohazard materials
- Occasional off-hours or weekend work may be required
- Physical Demands: Employees in this position may be required to perform the following physical activities: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 10 Ibs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements.
- Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to inspections and GMP requirements to perform essential functions of the job.
- The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients- Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
