Senior Director, Late Stage Cell Therapy Process Development

Responsibilities Provide strategic, technical leadership for late-stage process development of a PSC-derived islet product for Type 1 diabetes. Build and manage a high-performing process development team to develop commercial-ready manufacturing processes. Partner with Research to develop 3D stem cell seed train and differentiation processes, integrating bioreactors plus automated/closed technologies; lead DP process-enabling studies (formulation, fill/finish, cryopreservation). Lead process characterization and validation using DoE and QbD; support process performance qualification (PPQ). Establish and execute comparability strategy for pivotal process changes. Enable technology transfer to CDMOs or internal manufacturing; provide technical input to ensure successful implementation. Author/review CMC sections of regulatory submissions (IND, BLA), and support regulatory Q&A and inspections. Collaborate with multidisciplinary teams to deliver pivotal and commercial CMC. Hire, mentor, and develop engineers; drive continuous improvement. Contribute to organization strategy and innovation/career development; champion company culture. Qualifications Ph.D. in Biochemical Engineering, Chemical Engineering, or related field; 10+ years in cell therapy process development (5+ years late-stage); 5+ years leadership. Hands‑on experience with perfusion and single‑use bioreactor systems across benchtop to pilot/production scales; closed/automated manufacturing technologies. Stem cell biology knowledge; 2D/3D expansion/differentiation; GMP raw material selection. Engineering principles plus DoE/QbD for bioreactor scale up/down model development. Risk/root‑cause analysis tools (e.g., FMEA, Ishikawa). cGMP knowledge and regulatory expectations for commercial cell therapy/biologics. Experience supporting regulatory submissions, Q&A, audits/inspections; tech transfer of cell therapy processes. Strong influencing, matrixed fast‑paced collaboration, and excellent written/verbal communication. Preferred/Additional 10+ years direct experience from pre‑pivotal to commercial. Experience optimizing protocols to generate stem‑cell derived islets. PSC differentiation at >10L in bioreactors. Media development knowledge (spent media analytics and raw material regulatory expectations). Knowledge of PAT and analytical methods for deep product characterization. Track record implementing novel cell therapy manufacturing technologies into GMP. #J-18808-Ljbffr Scorpion Therapeutics