Tech Stack

Description

You will lead the MSAT team for Sana's stem cell-derived pancreatic islet cell program, overseeing technology transfer, manufacturing support, and CMC regulatory submissions for phase I clinical trials. Your work directly enables the delivery of engineered cell therapies to patients with type 1 diabetes.

Requirements

• BSc in Chemical, Biological, or Biomedical Engineering + 10 yrs experience
• 5+ yrs experience supporting early phase cell therapy manufacturing and tech transfers
• Well-versed in cGMP and regulated environment
• Experience managing a team of 3 direct reports
• Knowledge of PSC culture and differentiation biology to pancreatic islets

Responsibilities

• Lead a team of 2-4 individuals supporting Phase I manufacturing of PSC-derived pancreatic islet cell therapy
• Partner with CDMO for manufacturing readiness and technical problem-solving
• Oversee people-in-plant, operator training, and process execution
• Author CMC sections for regulatory filings (IND module 3)
• Lead investigations, deviations, and process improvements