Analytical DevelopmentCell TherapyImmunoassaysPotency Method Development
Useful technologies
JMPMicrosoft OfficeSmartsheetSoftmax Pro
Required qualifications
Study levelMaster's or higher
Original posting
About the role
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.
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
Get to know us
At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.