Car-t Operations Support Lead - Gent, België - Legend Biotech EU

Legend Biotech EU
Legend Biotech EU
Geverifieerd bedrijf
Gent, België

4 weken geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

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 backup for the Operations supervisor for the edition and review of logbooks, transfer forms (paper docs and MES)
  • Conduct routine and nonroutine (spot checks) inspection on documentation and GMP housekeeping in the support production zones
  • Control in a timely manner productionrelated 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 (backup of Operations Supervisor): 2nd point of contact representing Supporting Production quality matters in internal & external audits
  • Responsible to escalate productionrelated matters to Operations Supervisor out of their empowerment zone to ensure timely decision and followup
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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