Senior Director, Late Stage Cell Therapy Process Development

Sana Biotechnology • Cambridge, MA

3h • Onsite

About The Position

Sana Biotechnology is growing and is 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 translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing the pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. This role will require onsite leadership in Cambridge, MA.

Requirements

• Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
• Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
• Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
• In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
• Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
• Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
• Experience supporting regulatory submissions, Q&A and audits/inspections.
• Experience supporting tech transfer of a cell therapy process to manufacturing.
• Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
• Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.

Nice To Haves

• > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
• Experience with optimizing protocols to generate stem cell derived islets
• Experience with PSC differentiation at >10 L in bioreactors
• Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
• Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
• Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.

Responsibilities

• Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
• Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
• Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
• Establish and execute a comparability strategy for pivotal process changes.
• Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
• Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
• Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
• Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
• 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.

Benefits

• generous portion of the cost for employee health coverage
• 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
• Student Loan Repayment
• Employee Stock Purchase Plan
• commuter subsidy
• a variety of wellness offerings to support each person individually.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree