Senior Director, Late Stage Cell Therapy Process Development

Responsibilities

• Provide strategic and technical leadership for late-stage process development of a PSC-derived islet product
• Build and manage a high-performing process development team to develop commercial-ready manufacturing processes
• Partner with Research to develop 3D stem cell seed train and differentiation processes, including bioreactor integration
• Lead process characterization and validation activities using DoE and QbD approaches
• Establish and execute comparability strategies for pivotal process changes
• Enable technology transfer to CDMOs or internal manufacturing
• Author and review CMC sections of regulatory submissions (IND, BLA)
• Collaborate with multidisciplinary teams including Quality, Regulatory, and Manufacturing

Requirements

• Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline
• Minimum 10 years experience in cell therapy process development
• At least 5 years in a leadership role
• Hands-on experience with perfusion and single-use bioreactor systems
• Knowledge of stem cell biology and 2D/3D expansion/differentiation
• Expertise in engineering principles, DoE, and QbD
• Experience with risk and root cause analysis (FMEA, Ishikawa)
• Knowledge of cGMP and regulatory expectations for biologics
• Experience supporting regulatory submissions and inspections
• Experience supporting technology transfer to manufacturing

Preferred Qualifications

• 10 years direct experience from pre-pivotal to commercial cell therapy processes

• Experience optimizing protocols for stem cell derived islets
• Experience with PSC differentiation at >10 L in bioreactors
• Knowledge of media development and analytical tools for spent media
• Knowledge of process analytical technology (PAT)

About the Company

Sana Biotechnology is focused on the potential of engineered cells as medicines, translating novel ideas into clinical and commercial products to change the outcome of many human diseases.