This role is responsible for working closely with cell therapy process development team. This role reports to the Director of Cell Therapy Process Development and will work in close collaboration with the Technology Transfer, MSAT, Analytical Development, Drug Product, and Manufacturing teams to support departmental goals and objectives. This role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaborative skills.
- Plan, execute, analyze, report, and present data related to cell therapy process development studies.
- Perform full or scale-down experiments to support process development and characterization of cell therapy manufacturing processes.
- Independently manage assignments including sourcing of materials, equipment uses, time delegation, and risk identification/escalation to meet objectives.
- Support technology transfer activities to ensure the successful and timely execution of manufacturing goals.
- Communicate department goals, expectations, and capabilities to internal team members, and external vendors or clients.
- Flexible for occasional weekend work.
- Other duties, as necessary.
Education & Experience
- B.S (5+), or MS in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic/autologous cell therapy technologies and demonstrated laboratory proficiency.
- Prior knowledge and experience in the development of cell derived therapies (iPSC, MSC, NK, or T-cell) is required.
- Knowledge and experience with most equipment and unit operations of cell therapy process development is required.
- Prior experience in the technology transfer of new technologies is highly preferred.
- Must be able to author and review process development study protocols, reports, and batch records as needed.
- Prior experience in process characterization, in-process testing, and sample handling is preferred.
- Ability to thrive in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
- Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management