Laboratory Technician

The company is a global biotechnology firm dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, they are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From their three R&D sites around the world, they apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. For the branch in Zwijnaarde the company is looking for new Laboratory Technicians to participate with their research.

These are the responsibilities of a Laboratory 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

This is the profile of a Laboratory Technician:

• Graduate, Bachelor's, Master's degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required
• 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.
• Fluent in English, knowledge of Dutch is a plus.

This is the offer for a Laboratory Technician:

• You are part of a fast-growing international company.
• You will have the opportunity to participate in research with the ultimate goal of curing life-threatening diseases.
• Attractive salary package with various fringe benefits.
• Very modern, multicultural and highly technological working environment.