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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 want to challenge status quo, and who lead with the desire to work on novel ideas. The Vice President of Analytical Development provides technical and strategic leadership for a team developing analytical control strategies, characterization, release and stability methods of advance Sana’s pipeline. You will report into the Head of Technical Operations and will work closely with the Clinical, Regulatory, Finance, Legal, Research, Technology Sciences, and Technical Operations organizations to develop, deliver and ensure the successful execution of our analytical strategy throughout the product lifecycle. This position provides direction for Sana’s overarching analytical strategy, including method development, qualification, validation, and transfer activities as well as specification setting associated with the testing of our GMP products. The ideal candidate will have experience with Regulatory filings, preferably in the cell and gene therapy space. Additionally, this person should have experience leading large teams with leading leaders across multiple sites. This person will be a critical leader at the interface of Research and Discovery, GMP Manufacturing, Quality, and CMC regulatory. This leader will be required to lead a team of Analytical professionals working cross-functionally to support the Sana mission. The leader will be expected to build a positive work environment based on integrity, accountability, collaboration, innovation, communication. This position would preferably be based out of our South San Francisco, California location but will be responsible for teams across multiple sites.

What you’ll do

• Lead and build a multi-level, high-functioning Analytical Development organization, capable of developing industry-leading, innovative, robust strategies across cell and gene therapies
• Develop science-driven, phase appropriate, and risk-based analytical development control strategies to support programs from target nomination to clinical development
• Establish an effective department infrastructure and systems to enable efficient method development, specification setting, and method transfer by leveraging internal and external analytical expertise and capabilities
• Oversee method development, product specifications, stability studies and comparability assessments to enable clinical advancement of Sana’s portfolio
• Provide strategic leadership and manage the activities of the Analytical Development and Analytical Operations personnel, including oversight of routine testing in support of process and product development
• Lead/participate in CDMO/Contract Lab selection and management as well as auditing as needed
• Establish and maintain cross-functional relationships to ensure efficient and effective handoffs of Sana technologies and methods
• Lead analytical method definition and development required for testing of process related impurities, intermediates, drug substances, and drug products
• Establish strategy and accountable for execution of authoring of the analytical sections for Regulatory filings
• Serve as key strategic member of the Technical Operations team assessing analytical capabilities and processes; and providing guidance for best practices and direction for continuous improvement
• Ensure the organization meets budgeted financial goals and objectives
• Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time
• Lead strategic planning and annual goal setting process, talent, and succession planning, OPEX and CAPEX process in collaboration with Finance and HR business partners
• Responsible for selection, budgeting, and relationships with contract laboratories
• Ensure overall operational budget is within the approved budget and timeline
• Be a champion of Sana’s values including One Sana
• Oversee CMC sections of regulatory submissions and provide leadership as a Subject Matter Expert in regulatory interactions when needed
• Provide strong leadership on quality, safety, and operational excellence initiatives
• Ensure team maintains training and meet compliance standards as appropriate
• Develop, mentor and coach the analytical staff to function effectively in cross-functional teams and collaborations
• Drive and support an innovative startup environment
• Communicate with facts, clarity, and authenticity up, down, and across sites and organizations
• Ability to attract, hire, and build a world class analytical team
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• Education: BS minimum, Master or PhD in cell, molecular, or general biology, biochemistry, life sciences or related field. Experience: BS + 25 years, Master +22 years or PhD +20 years of experience in biotech/biological/vaccine assay development or related biotech process development. Skills: technical leadership, site management, project management and people management
• Extensive previous managerial experience responsible for growing and developing a multi-level organization across multiple sites
• Strong knowledge of analytical development, CMC regulatory, and Quality within the cell and gene therapy space
• Demonstrated expertise with a range of analytical techniques such as flow cytometry, ELISAs, qPCR, ddPCR, and cell based assays
• Experience with CMC regulatory, regulatory filings, global regulations, and inspections
• Ability to work collaboratively in a complex, multi-site, matrixed, fast-paced environment; proven ability to foster team productivity and cohesiveness, as well as the ability to drive innovation within the team
• Lead leaders with the ability to motivate a multi-level team delegate effectively, celebrate diversity within the team and manage performance; widely viewed as a strong developer of others

What will separate you from the crowd

• Knowledge of product development, from conception through pilot, clinical, and commercial manufacturing in cell or gene therapy
• Experience in developing, deploying, and maintaining cGMP standards
• Demonstrated skills and experience in strategic management, planning and execution.
• Strong understanding of ICH guidelines, compendia, and regulations related to GMP release testing of cell and gene therapies
• Demonstrated skills in team building, mentoring, coaching and people
• Strong business, Quality and financial acumen

What you should know

• Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
• The base pay range for this position at commencement of employment is expected to be between $325,000 – $375,00; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience