Senior Scientist, Cell Therapy Process Development

JOB PURPOSE

We are seeking a talented and motivated individual to join the Upstream Process Development group as a Senior Scientist. This candidate will lead development of a production scale pluripotent stem cell-derived beta islet manufacturing process. The candidate will join an innovative multi-disciplinary team developing cell therapy manufacturing technologies to bring allogeneic PSC-derived beta cell therapies into clinical trials.

DUTIES AND RESPONSIBILITIES

• Develop scale down models of pluripotent stem cell expansion and differentiation, customize media, and develop, optimize, and characterize at-scale upstream and downstream processes.
• Drive scientific advances in our understanding of PSC bioprocessing
• Collaborate closely with beta cell research program and hypoimmune PSC development program. Advise both programs on CMC considerations.
• Create and manage technical development plans tied to tangible and time-bound deliverables
• Adapt process for GMP-ready manufacturing. Tech transfer processes to other Sana sites and external manufacturing organizations.
• Lead and manage scientific team. Maintain a functioning cell therapy bioprocess lab.

QUALIFICATIONS

Basic Qualifications

• Ph.D. in scientific discipline w 5+ yrs experience in bioengineering, chemical engineering, or related field. BA or MS plus 8+ yrs or equivalent combination of education and work experience; Deep subject matter expertise and an emerging leader.
• Strong knowledge of small scale process development, preferably in an allogeneic cell therapy industry context
• Hands-on experience with stem cell culture and differentiation
• Excellent communication, documentation, and presentation skills
• The candidate should be a team player, highly organized and demonstrate curiosity and scientific rigor and excellent problem-solving skills.
• Ability to engage in crucial conversations - providing and receiving feedback

Preferred Qualifications

• Hands-on experience with PSC biology, bioengineering, differentiation and process development
• Hands-on experience with bioreactor unit operations at bench and pilot scale
• Working knowledge of DoE methods for experimentation and statistical analysis
• Direct, hands-on industrial experience with biologics, gene, and/or cell therapy process development, including ownership of key process decisions
• Strong understanding of culture media development
• Understanding of the data package and reports required to advance processes into clinical manufacturing
• Motivated, curious, comfortable working with highly technical projects and personnel
• Direct industrial experience managing projects
• Direct prior industrial experience managing 1-2 direct reports

WORKING CONDITIONS

This is a lab-based role, with occasional weekend work. Some travel required including tech transfer and CMO-related travel.

PHYSICAL REQUIREMENTS

Occasional lifting of bioreactors and media (up to approximately 20kg).

Lab work (standing)