Senior Director, Late Stage Cell Therapy Process Development

What this role involves

The Senior Director, Late Stage Cell Therapy Process Development leads late-stage process development for a PSC-derived islet product for Type 1 diabetes. They manage a team, oversee tech transfer, process characterization, and regulatory submissions, requiring onsite work in Cambridge, MA. The role demands a PhD with 10+ years experience in cell therapy process development and 5+ years in leadership.

Skills this posting asks for

• cell therapy process development
• perfusion bioreactor
• single use bioreactor
• stem cell biology
• 2d/3d stem cell expansion
• differentiation
• design of experiments
• quality by design
• fmea
• ishikawa
• cgmp
• regulatory submissions
• tech transfer
• bioreactor scale up
• scale down model development
• formulation
• fill/finish
• cryopreservation
• process characterization
• process validation
• process performance qualification
• cmc

Requirements

• 10 years of experience
• Level: director
• Remote policy: onsite

From the employer’s posting

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. A…