Operations Technician

il y a 1 semaine

Gent, Flandre, Belgique Legend Biotech EU Temps plein

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
As CAR-T Operations Technician, you will conduct the CAR-T process operations (i.e. cell culture, purification, aseptic processing, fill &finish and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format. You will perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.

You will need to establish smooth and excellent collaborations with Planning, MS&T, OPEX, QC, Maintenance & Engineering, Facility & Utilities, Warehouse, IT and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.

The CAR-T Operations Technician will support the development of manufacturing processes, and will work with MS&T and OPEX to drive continuous improvements and efficiencies within CAR-T Operations.


As key member of Operations, The CAR-T Operational Technician:

  • Works daily in a cleanroom manufacturing environment (Grade A/B/C/D)
  • Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas, mainly in grade B, C, D.
  • Manufactures clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill and finish and cryopreservation of cells according to SOPs and aseptic techniques
  • Performs in process control testing on batch samples, such as cell counting and viability
  • Keeps equipment operating by following operating instructions, troubleshooting breakdowns and calling for repairs
  • Contributes to activities related to processes optimizations, and introduction of new products, procedures and equipment in GMP areas
  • Participates in the followup of QMSrelated tasks, including Change Control Request (CCR), deviations/events and CAPA
  • Provides support to writing and revising SOPs and associated documents (incl. batch records, work files, checklists, procedures) related to routine Production documentation.
  • Manages raw materials, consumables and wastes, incl. preparation of internal orders, entry and exit from the zones, cleaning and storage, according to SOPs
  • As part of the development program, the CAR-T technician can get the proper training and qualification to prepare sterile culture media and solutions according to SOPs and aseptic techniques
  • Completes diligently all GMP documentation (forms, reports, logs, and records of equipment and batches)
  • Communicates clearly with the Ops Supervisor, Technical Leads
  • Clean room and Operational experts to highlight on production status or any items related to safety, quality and efficiency
  • Uses various manufacturing execution systems (e.g. eLiMS, MES, SAP), and supports to testing and implementation of these.
  • Works in a constructive and flexible way in a team

Qualification:

  • Graduate, Bachelor's, Master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required
  • A minimum of 1 year hands on operations experience within a cGMP or ATMP environment in the biotech/biopharma industry is preferred
  • Minimum 1 year handson experience in aseptic techniques in clean rooms is preferred
  • Knowledge of GMP is preferred
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate crossfunctional issues and balance competing priorities effectively.
  • Strong influence and relationship building skills with an emphasis on teamwork
  • Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
  • Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell based products.
  • Focus on quality, compliance and detail
  • Ability to work in (transversal) teams
  • Team spirit
  • Strong problem solving, pragmatic and positive critical thinking skills
  • Can do attitude, Right first time
  • Selfmotivated, enthusiastic personality, team player with a desire to learn new skills
  • Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
  • Selfmotivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
  • Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred
  • Ability to accommodate unplanned overtime on little to no prior notice
  • Ability to accommodate changes in the schedule including working in other shifts, evenings and weekends as per operational needs is required.
  • Dutch & English
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