Tech Stack

Description

You will lead the MSAT team for Sana Biotechnology's stem cell-derived pancreatic islet cell program, overseeing technology transfer, manufacturing readiness, and CMC regulatory sections. Collaborate with CDMOs and internal teams to ensure phase I manufacturing success and drive process improvements.

Requirements

• BSc. in Chemical, Biological, or Biomedical Engineering plus 8 years experience
• 3 years experience supporting early phase cell therapy manufacturing including tech transfers
• Experience with cGMP and regulated environment, including as person-in-plant
• Experience operating perfusion bioreactors and with fill/finish unit operations
• Experience managing a team of 2 direct reports

Responsibilities

• Lead MSAT team of 1-2 individuals supporting phase I manufacturing of cell therapy product
• Partner with CDMO technical team to achieve manufacturing readiness and address challenges
• Oversee people-in-plant, operator training, technical documentation, and process execution
• Draft CMC sections for regulatory filings (IND module 3) and other technical documents
• Collaborate with Quality to close deviations, analyze trends, and recommend process improvements