Senior Director, Late Stage Cell Therapy Process Development
Sana Biotechnology, Inc.
August 06, 2026
On-site
Cambridge, MA
Operations
Responsibilities:
- Provide strategic/technical leadership for late-stage process development of a PSC-derived islet product for Type 1 diabetes.
- Build/manage a process development team developing commercial-ready manufacturing processes.
- Partner with Research to develop 3D stem cell seed train and differentiation processes (bioreactors; automated/closed technologies) and DP process-enabling studies (formulation, fill/finish, cryopreservation).
- Lead process development ensuring scalability, robustness, quality, and regulatory compliance.
- Lead process characterization/validation using DoE and QbD; support PPQ.
- Establish/execute comparability for pivotal process changes.
- Enable technology transfer to CDMOs or internal manufacturing; ensure successful implementation.
- Author/review CMC sections of IND/BLA; support regulatory Q&A and inspections.
- Collaborate across Research, Analytical, Quality, Regulatory, Manufacturing, Clinical, and Supply Chain to deliver pivotal and commercial CMC.
- Hire/mentor engineers; drive continuous improvement.
Qualifications:
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related; 10+ years cell therapy process development (5+ late-stage), including 5+ years in leadership.
- Hands-on perfusion and single-use bioreactors (bench to pilot/production) enabling closed/automated manufacturing.
- Stem cell biology and 2D/3D expansion/differentiation; GMP raw material selection.
- Engineering principles; DoE/QbD for scale-up/scale-down modeling.
- Risk/root-cause analysis tools (e.g., FMEA, Ishikawa).
- cGMP knowledge and quality/regulatory expectations for commercial cell therapy/biologics.
- Regulatory submission/Q&A and audit/inspection experience.
- Tech transfer experience.
- Strong influencing, matrix collaboration, and written/verbal communication.
Preferred/Additional:
- >10 years developing cell therapy processes from pre-pivotal to commercial.
- Protocol optimization for stem cell–derived islets; PSC differentiation >10 L in bioreactors.
- Media development/analytical tools; PAT and analytical methods for deep product characterization.
- Track record implementing novel manufacturing technologies into GMP.
Compensation:
- Base pay range expected: $250,000–$300,000/year (varies by factors including location and experience).
- Provide strategic/technical leadership for late-stage process development of a PSC-derived islet product for Type 1 diabetes.
- Build/manage a process development team developing commercial-ready manufacturing processes.
- Partner with Research to develop 3D stem cell seed train and differentiation processes (bioreactors; automated/closed technologies) and DP process-enabling studies (formulation, fill/finish, cryopreservation).
- Lead process development ensuring scalability, robustness, quality, and regulatory compliance.
- Lead process characterization/validation using DoE and QbD; support PPQ.
- Establish/execute comparability for pivotal process changes.
- Enable technology transfer to CDMOs or internal manufacturing; ensure successful implementation.
- Author/review CMC sections of IND/BLA; support regulatory Q&A and inspections.
- Collaborate across Research, Analytical, Quality, Regulatory, Manufacturing, Clinical, and Supply Chain to deliver pivotal and commercial CMC.
- Hire/mentor engineers; drive continuous improvement.
Qualifications:
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related; 10+ years cell therapy process development (5+ late-stage), including 5+ years in leadership.
- Hands-on perfusion and single-use bioreactors (bench to pilot/production) enabling closed/automated manufacturing.
- Stem cell biology and 2D/3D expansion/differentiation; GMP raw material selection.
- Engineering principles; DoE/QbD for scale-up/scale-down modeling.
- Risk/root-cause analysis tools (e.g., FMEA, Ishikawa).
- cGMP knowledge and quality/regulatory expectations for commercial cell therapy/biologics.
- Regulatory submission/Q&A and audit/inspection experience.
- Tech transfer experience.
- Strong influencing, matrix collaboration, and written/verbal communication.
Preferred/Additional:
- >10 years developing cell therapy processes from pre-pivotal to commercial.
- Protocol optimization for stem cell–derived islets; PSC differentiation >10 L in bioreactors.
- Media development/analytical tools; PAT and analytical methods for deep product characterization.
- Track record implementing novel manufacturing technologies into GMP.
Compensation:
- Base pay range expected: $250,000–$300,000/year (varies by factors including location and experience).