Reporting to the Head of Production, this position is focused on the coordination of transfer of UCART processes and analytical methods to Contract Manufacturing Organizations and routine management of the GMP Manufacturing operations at the entities. You will be accountable for the operational aspects of the transfers and GMP manufacturing operations, including contingency plans, to meet planned demand with adherence to the GMP compliance. You will also insure that appropriate ways of working are established with the CMO and alert Cellectis management in case of deviations. Finally, you will propose process optimizations to improve the yield and functionality based on your experience, knowledge and know-how.
Job duties include:
- Interactions with Contract Manufacturing Organizations (CMOs): project management and planning, follow-up of activities to ensure respect of timelines. Emergency management in interaction with other internal teams including quality, regulatory and process/analytical development teams.
- Ensuring the coordination of technology transfer to CMOs.
- Ensure collection, analysis and reporting of manufacturing data in close connection with process development.
- Participating to the writing of CMC sections for regulatory applications.
- Providing manufacturing input in process development strategies and coordination of the implementation of process/analytical changes at CMOs.
- Ensuring proprietary equipment qualification at CMOs.
- Developing and implementing procedures and generic timelines to support tech transfer and routine follow-up of the manufacturing activities.
- Master degree, PhD or PharmD or equivalent with 3-5 years of experience in cell therapy GMP manufacturing. Creativity, capacity to innovate and previous management experience would be assets for the position.
- Strong knowledge of GMP operational manufacturing in clean room environment.
- Experience, adaptation and implementation of GMP regulations is a plus.
- Knowledge and experience in EU and US GMP regulations.
- Strong knowledge of cell culture processes.
- Experience in project management in multifunctional, international environment
- Excellent communication skills, written and oral, can-do mentality and ability to report strategic summaries to team members and stake holders.
- Ability to effectively manage multiple, complex priorities.
- Fluency in English.
- Negotiation skills.
- Ability to apply multidisciplinary approaches.
- Ability to work with clearly defined critical paths, milestones and timelines.