As CAR-T Operations Technician, you will be part of the Core Operations Team, responsible for directing the daily CAR-T operations and production to timely support (i) clinical and (ii) commercial readiness and (iii) commercial CAR-T product supply to both Europe and US. You will be performing the daily manufacturing operations within a sterile cGMP environment per quality and safety standards.

You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.

RESPONSIBILITIES

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, Manufacturing Process & Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule. The CAR-T Operational 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)
• 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, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
• Performs operational tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
• Keeps equipment operating by following operating instructions, troubleshooting breakdowns and calling for repairs
• Contributes to activities related to processes optimization, and introduction of new procedures, products and equipment in GMP areas
• Provides support to writing and revising SOPs and associated documents (incl. batch records, work files, checklists, procedures) related to routine Production documentation.
• Communicates clearly with the Ops Manager and Operational SMEs 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 based, cross-functional environment.

REQUIREMENTS / QUALIFICATIONS

• Graduate, Bachelor’s or 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 hands-on experience in aseptic techniques in clean rooms is preferred
• Knowledge of GMP is preferred
• Experience in manufacturing, maintenance, quality, testing, or engineering areas is preferred
• Strong influence and relationship building skills with an emphasis on teamwork
• Highly developed organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving, pragmatic and positive critical thinking skills
• Can do attitude, Right-first-time and hands-on approach
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Focus on quality, compliance and detail
• Ability to work in (transversal) teams - Team spirit
• Self-motivated, 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
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
• 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.
• Fluent in English and Dutch.

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