Lab Technician- Biotechnology-Gent

• 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
• 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
• Works in a constructive and flexible way in a team

• 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.

• 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.

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