- Lead or support the transfer of process to CMO for early phase cGMP clinical manufacturing.
- Design and execute process development experimental plans and provide associated protocols and final reports, present updates and data to teams.
- Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
- Maintain all individual training requirements in a compliant state.
- Lead the development of phase-appropriate cell therapy production processes using QBD principles.
- Oversee development activities for platform production processes and ensure processes are suitable for early and late-stage cGMP clinical development and commercialization.
- Identify and evaluate new technologies to improve manufacturing outcomes such as: reduce costs, throughput, and quality.
- Contribute to regulatory filings as needed for IND and future BLA submissions.
- Oversee CMO manufacturing operations, including data capture, batch record and testing form review, deviation investigation and CAPAs.