Sana Biotechnology is seeking a Senior Director, Late Stage Cell Therapy Process Development to lead process development and technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. The role will require onsite leadership in Cambridge, MA.
Requirements
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline
- Minimum 10 years experience in cell therapy process development, with at least 5 years late stage development and 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
- Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation
- In depth knowledge and experience with application of engineering principles, DoE and QbD approaches
- 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
- Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
- Student Loan Repayment
- Employee Stock Purchase Plan
- Commuter Subsidy
- Wellness Offerings