Vice President, Head of Analytical Development

The Vice President of Analytical Development at Sana Biotechnology will provide technical and strategic leadership for the development of analytical control strategies, methods, and specifications for Sana's pipeline of engineered cell medicines. This role will involve collaborating with various departments and leading a team of analytical professionals to ensure the successful execution of the company's analytical strategy throughout the product lifecycle. The ideal candidate will have experience with regulatory filings in the cell and gene therapy space, as well as experience leading large teams across multiple sites. This position will play a critical role in bridging the gap between research, manufacturing, quality, and regulatory functions.

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 environment

• 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.
• Technical leadership, site management, project management, and people management skills.
• 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.
• 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 planning and annual goal setting process, talent, and succession planning, OPEX and CAPEX process.
• Excellent communication skills with the ability to communicate with facts, clarity, and authenticity up, down, and across sites and organizations.
• Ability to attract, hire, and build a world-class analytical team.
• Innate ability to assess talent that will help grow the organization and add to Sana's culture.

• 100% coverage of employee health coverage
• Generous time-off benefits (holidays, vacation, sick time, parental leave)
• Short- and long-term disability coverage
• Employer paid basic life insurance
• Additional voluntary life insurance protection
• Financial wellness programs and resources
• 401(k) Plan with an immediately vested employer match
• Tuition Reimbursement and Student Loan Repayment
• Employee Stock Purchase Plan
• Commuter subsidy
• Variety of wellness offerings to support individual well-being