Director, MSAT

Role: MSAT Director leading technical support for Phase I manufacturing of Sana's stem cell-derived pancreatic islet cell therapy for type 1 diabetes. Responsibilities: manage a team supporting process development, technology transfers, batch execution, and documentation; collaborate with external CDMOs and internal Quality, Regulatory, and Supply Chain teams; author regulatory CMC documents (IND module 3); lead investigations, troubleshoot process issues, and drive continuous improvement; ensure manufacturing readiness and technical compliance. Requirements: BSc in Chemical, Biological, or Biomedical Engineering; 10+ years of relevant experience including early-phase cell therapy manufacturing support; knowledge of cGMP, regulated environments, and PSC culture/differentiation biology; leadership experience with >3 direct reports; strong problem-solving, technical writing, and cross-disciplinary collaboration skills. High-Value: cell therapy (PSC-derived pancreatic islet cells), Phase I, regulatory document authoring, external manufacturing oversight, experience with GMP cleanroom environments, cell culture, and differentiation biology, and familiarity with analytical methods. Work setup involves ~25% travel in Canada; some weekend work; work in cleanroom settings. The role emphasizes leadership, scientific rigor, and collaboration within a fast-paced, innovative cell therapy environment.