Car-t Operations Supervisor
il y a 4 heures
**Company Information**
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**ROLE OVERVIEW**
The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule
You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
**RESPONSIBILITIES**
The CAR-T Operations Supervisor will lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
The CAR-T Operations Supervisor will need to build strong partnerships with Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain / Warehouse to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for technicians and experts on the production floor.
Be the SME for Quality aspects related to Production activities:
- Coordinate, manage and control all quality aspects related to production activities and production of batches in cGMP areas:
- Manage and review in a timely manner « documentation » activities in Production zones (incl. Procedures, work instructions, logbooks, transfer forms )
- Edition and review of executed batch records (paper doc & MES)
- Conduct routine and non-routine (spot checks) inspection on documentation in the production zones
- Write or revise and control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality:
- Change Control Requests (CCR), Deviations/events, and CAPA
- Master Batch Records of products and preparations, SOPs and associated documents, cleaning validation, shut down and media fill simulation protocols and reports
- Review cGMP documents generated by the Production for technicians and experts before review by QA
- Manage and communicate KPI's related to quality aspects in Production
- Production SME for internal & GMP inspections in collaboration with QA (back-up of Operations manager):
- 2nd point of contact representing Production quality matters in external audits
- First line communication with QA Ops for quality matters, and responsible to escalate production-related matters out of their empowerment zone to ensure timely decision and follow-up
Be the SME for Production aspects related to CAR-T Products and Processes:
- Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
- Support to the Tech Transfer plan for new production introduction or process optimization, led by MS&T/Manufacturing Excellence (Engineering runs & PPQ runs), including definition of needs, risk assessment, execution and readiness for clinical & commercial
- Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Support to the qualification/validation plan of new materials, consumables and equipment, led by MS&T/Manufacturing Excellence, including definition of needs (URS) and implementation.
- Support to drug product investigations (including batch failures)
- Participate in the training to the different manufacturing processes (product manufacturing steps and preparations)
- Manage and communicate KPI's related to output in Production
Production Organization and capabilities, people management:
- Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks
- Organize and supervise trainings together with Training
- Work closely with Operations Manager to help oversee the development of production personnel and provide input on personnel performance
- Support Budget monitoring and control of production-related cost center expenses in close cooperation with the Ops Manager / Head of Operations
- Support to:
- Quality and EHS Risk assessment on production acti
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