Car-t Operations Support Lead
Il y a 5 mois
**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 Support Lead is an exempt level position working with the Technical Operations team, responsible for the coordination and co-execution of the supporting activities to perform 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.
**RESPONSIBILITIES**
The CAR-T Operations Support Lead is a supervisor on the floor and will lead, coordinate and co-execute the support of the CAR-T process operations (material transfer; replenishment and inventory; maintaining the clean rooms up to standards linked with the cleaning maintenance; packing, sealing and sterilization of materials and documents) according to standard operating procedures, and ensure safe and compliant manufacturing operations according to cGMP requirements.
The CAR-T Operations Support Lead will need to build strong partnerships within Manufacturing Operations (co Operations Support Leads, Technical Clean Room Leads, Supervisors and Manager), QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Warehouse to ensure seamless and timely execution of daily production tasks and work as part of a cross-functional team to address production support issues as the first point of contact for support operators on the production floor.
Be the SME for Quality aspects related to Production activities:
- Coordinate, manage and control all quality aspects related to support production activities:
- Review in a timely manner « documentation » activities in support Production zones (incl. Procedures, logbooks, transfer forms, S4 related documentation)
- Act as a back-up for the Operations supervisor for the edition and review of logbooks, transfer forms (paper docs and MES)
- Conduct routine and non-routine (spot checks) inspection on documentation and GMP housekeeping in the support production zones
- Control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality:
- Deviations/events, and CAPA
- Support communication concerning KPI's related to quality aspects in Production
- Production SME for internal audits and external audits in collaboration with QA (back-up of Operations Supervisor): 2nd point of contact representing Supporting Production quality matters in internal & external audits
- Responsible to escalate production-related matters to Operations Supervisor out of their empowerment zone to ensure timely decision and follow-up
Be the SME for Production support aspects related to CAR-T Products and Processes:
- Work closely and together with support operators 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 optimisations of current processes within the support production areas
- Participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Communicate KPI's related to supporting output in Production
- Provides support to writing and revising SOPs and associated documents (work files, checklists, procedures) related to routine Supporting Production documentation.
- Uses various manufacturing execution systems (e.g. eLiMS, SAP, MES), and supports to testing and implementation of these.
Production Organization and capabilities, people management:
- Works daily in a cleanroom manufacturing environment (Grade B/C/D & CNC)
- Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
- Manage packing, sealing and sterilisation of materials and documents
- Manage timely transfer of apheresis material, raw materials, consumables to the applicable clean room and manage timely final product transfer from production zone to CRF Zone
- Manage the waste in the applicable production zone and in concreto, frequency of emptying the waste airlock
- Manage inventory counts, preparation of internal orders, entry and exit from the zones, cleaning, replenishment and storage, according to SOPs and per issued planning
- Be present at the daily start of shift operations meetings and the daily wrap up production meetings. Act as a back up for the Ops Supervisor and lead the daily start of shift operations meetings, daily wrap up production meetings in his/her absence
- Assign to support operators their daily production task to execute and ensure
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