Operations Technician - Gent, België - Legend Biotech EU

Legend Biotech EU

Geverifieerd bedrijf

Gent, België

1 week geleden

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
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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