Responsibilities Include
- Independently design and execute process development experimental plans, provide associated protocols and final reports as needed, and present updates and data to teams.
- Perform cell-based analytical assays as needed to support PD work.
- Accurately capture and analyze data in a timely manner, ensuring data integrity and protocol compliance.
- Maintain all individual training requirements in a compliant state.
- Support phase-appropriate cell therapy production processes using QBD principles.
- Identify and evaluate new technologies to improve manufacturing outcomes such as: reduced costs, increased throughput, and enhanced quality.
- Maintain laboratory material and sample inventory, support the planning of MSAT process development materials needs and coordinate purchasing with lab manager.
- Support the transfer of process to CMO for early phase cGMP clinical manufacturing as needed.