About the job
Join AbbVie as a key member of our production team in Martillac. Under the guidance of the USP Manager, you will play an essential role in the large-scale production of recombinant proteins derived from mammalian cells, adhering to GMP conditions. The USP Production Coordinator is pivotal in operational management, ensuring GMP compliance and driving continuous process improvement.
This is a daytime position (not subject to a 3x8 schedule), with no direct management responsibilities but requiring cross-functional accountability with team leaders and support functions.
Main Responsibilities:
Operational Support and Oversight:
- Assist the USP Manager in the organization, planning, and coordination of cell culture production activities.
- Ensure operations are compliant with production schedules and GMP requirements.
Quality Support Management:
- Manage or support deviations & CAPA: open deviations, participate in Booster meetings, assessments, handle deviations, implement and track CAPA actions.
- Change Control: initiate and vet CCPs, approve and monitor associated actions.
- Inspection Readiness: partake in audit preparations, track action plans, and manage workshop readiness.
EHS (Environment, Hygiene, Safety):
- Actively participate in EHS inspections and implement corrective actions.
- Contribute to maintaining a safe and compliant work environment.
Process Transfer and Technical Documentation Management:
- Engage in process transfer activities, validate MBRs and production recipes.
- Coordinate between MSAT and production teams for new process integration.
Cell Culture Operations Management:
- Coordinate with support functions (Quality, Engineering, Logistics, Planning).
- Participate actively in operational preparations (track BOM/POP needs, define level III planning framework).
Post-Production and Continuous Improvement:
- Audit and review batch records post-production.
- Monitor corrections and improvement actions.
- Participate in and track specific projects within the service.
- Lead or contribute to continuous improvement projects focusing on performance, quality, and safety.
Backup Responsibilities:
- Act as backup for the manager on operational topics during absences.
- Provide support to operational teams: technical and scientific assistance.
- Oversee and coordinate activities related to the development of cell culture operations.