Director, MSAT

Sana Biotechnology

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.

Responsibilities

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

Requirements

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

Apply

Vacancy posted 14 days ago

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