Senior Director, Cell Therapy Process Development

As the Senior Director of Cell Therapy Process Development at Sana Biotechnology, you will play a crucial role in guiding and overseeing late stage process development activities. Your responsibilities will include mentoring a team of Process Engineers and Scientists, defining process characterization and PPQ strategy, and supporting technology transfers to manufacturing sites. You will collaborate with multidisciplinary teams to implement manufacturing strategies and advance Sana's cell therapy process to commercial readiness. This role requires strong leadership skills, technical expertise in T cell biology and unit operations, and the ability to drive innovation and deliver results within fast timelines.

Lead and oversee a Process Development team to advance later stage programs, including process characterization

Work with CMC leads to draft IND and BLA sections

Drive process development initiatives across the organization

Support external and internal technology transfer activities at manufacturing sites

Identify and evaluate novel technologies to build best-in-class platforms

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

Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work

• BSc in Science or Engineering with 12+ years of experience in process development or equivalent combination of education and work experience; at least 6 years leading a team
• 5 years of cell therapy process development experience supporting early- and late-stage programs
• Advanced technical knowledge of T cell biology and unit operations including isolation, expansion, bioreactors, lentiviral transduction, and gene editing
• Ability to build, manage, and mentor a team of engineers and scientists
• Prior experience with process characterization, DoE, QbD, and demonstrated abilities in risk analysis
• Experience overseeing technology transfer of a cell therapy process internally and/or externally for cGMP manufacturing
• Excellent organizational skills and an ability to prioritize to deliver results within fast timelines
• Strong influencing skills and ability to work in a matrixed environment
• Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization
• Demonstrated track record driving cell therapy processes to commercial readiness, including at least 1 late stage or commercial program
• Working knowledge of late stage process development strategy including comparability, process characterization/validation, and PPQ
• Experience supporting internal and external tech transfers on fast timelines
• Strong understanding of immunology and T cell biology
• Deep understanding of cell therapy cGMP manufacturing, including Quality expectations
• Statistical design of experiments (DoE), QbD, and knowledge of root cause analysis and tools (e.g. FMEA, Fishbone/Ishikawa diagram)
• Strong track record of identifying and implementing novel cell therapy manufacturing technologies
• Experience driving productive multidisciplinary projects with Research, Analytical Development, and Manufacturing partners
• Knowledge of analytical development including flow cytometry and cell-based assays

• 100% coverage of employee health coverage
• Various paid 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 including financial planning 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 each person individually
• Workplace free of discrimination and harassment
• Reasonable accommodations for individuals with disabilities