Senior Director, Late Stage Cell Therapy Process Development

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 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 our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff! This role will require onsite leadership in Cambridge, MA.

What you'll do

* 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.

What we're looking for

* 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.

What will separate you from the crowd

*  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.

What you should know

* The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/year; 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…