Director, MSAT
Sana Biotechnology · Cambridge, MA
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Role summary
Sana Biotechnology seeks a Director of Manufacturing Science and Technology to lead a team supporting Phase I manufacturing of a pluripotent stem cell-derived pancreatic islet cell therapy. This role involves technology transfer strategy, regulatory documentation, external partner coordination, and team management for an engineered cell therapy program.
What they're looking for
- BSc in Chemical, Biological, or Biomedical Engineering plus 10 years relevant experience
- 5+ years supporting early-phase cell therapy manufacturing and technology transfers
- Deep knowledge of cGMP requirements and regulated manufacturing environments
- Expertise in PSC culture and differentiation to pancreatic islet cells
- Management experience leading teams of 3+ direct reports
- Strong technical writing, problem-solving, and communication skills
What you'll be doing
- Lead team of 2-4 individuals supporting Phase I manufacturing of PSC-derived pancreatic islet therapy
- Partner with CDMO to achieve manufacturing readiness and resolve technical challenges
- Author CMC regulatory sections (IND module 3) and technical documents
- Oversee on-site manufacturing oversight, operator training, and batch record review
- Conduct process investigations, root cause analysis, and comparability studies to assess technology transfer success
Privacy & handoff
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