Associate Director, MSAT

Responsibilities

• Lead a team supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical teams 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)
• Collaborate with Quality to close deviations and analyze manufacturing trends
• Lead investigations and troubleshoot process execution challenges using root cause analysis
• Perform comparability studies in collaboration with Research and PD teams

Requirements

• BSc. in Chemical, Biological, or Biomedical Engineering plus 8 years experience or equivalent
• Over 3 years experience supporting early phase cell therapy manufacturing and technology transfers
• Proficiency with cGMP requirements and regulated environments
• Experience operating perfusion bioreactors and fill/finish unit operations
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of 2 or more direct reports
• Strong technical writing and problem-solving skills

Preferred Qualifications

• Experience with PBS bioreactors and key cell therapy equipment
• Familiarity with cell therapy drug product development and stability studies
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom environments
• Knowledge of single-use technologies and process automation
• Understanding of analytical methods such as flow cytometry
• Proficiency with R, Python, JMP, or FlowJo

About the Company

Sana Biotechnology is focused on the potential of engineered cells as medicines, working to deliver novel cell-based therapies to patients with diseases like type 1 diabetes.