This role is responsible for leading a team tasked with the tech transfer, process development, and process characterization of cell therapies.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 execute process characterization and IND/BLA enabling studies. Execution of this role requires a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaborative skills. This position requires extensive knowledge of late-phase manufacturing, process characterization, IND and BLA enabling study design, and other activities as deemed necessary by program leadership.
- Oversee the strategy, planning, analysis, and execution of studies designed to drive successful process development and process characterization of cell therapies.
- Accountable for technology transfer of early or late phase cell therapy programs.
- Utilize prior experience to identify and forecast phase specific process development and process characterization strategies including a scale-down model strategy.
- Technical authoring of documents critical to tech transfer, process development, and process characterization of cell therapy programs.
- Demonstrate effective leadership to drive product development while adhering to FTEs/budget, regulatory standards, and company goals.
- Assess risk and opportunity to identify solutions to optimize to achieve departmental objectives while mitigating potential risks using effective cross-departmental collaboration.
- Provide expert scientific advice to client and cross-functional teams for successful execution of planned development studies.
- Communicate department goals, expectations, and capabilities to internal team members, and external vendors or clients.
- A minimum MS / BS and 8+ years’ experience or PhD and 5+ years’ experience.
- Extensive knowledge and experience in designing process development and process characterization studies of cell therapy or biologics manufacturing processes.
- Excellent communication and leadership skills are required to support client-based programs.
- Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies.
- Demonstrated experience with tech transfer, process development, process characterization and regulatory approvals (IND and BLA)
- Thrives 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