CAR-T Operations Technician

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 follow-up of QMS-related 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 hands-on 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 cross-functional issues and balance competing priorities effectively.
• Strong influence and relationship building skills with an emphasis on teamwork
• In-depth understanding of function and application of product
• 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 • 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
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
• Proficient user of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
• 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