Our client is a globally renowned biotechnology company committed to treating and ultimately 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 its four locations around the world, they apply these innovative technologies to pursue the discovery of safe, effective and advanced therapies for patients worldwide.
To continue to conduct this extremely important research, they are looking for new new Laboratory Techniciansfor the Zwijnaarde branch (located in the Technology Park)
This is the tasks of a Laboratory 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.
- Performs in process control testing on batch samples, such as cell counting and viability.
- Keepsequipmentoperating by followingoperatinginstructions, troubleshooting breakdowns and callingforrepairs
- 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.
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.
- In-depth understanding of function and application of product.
- Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell based products.
- Strong problem solving, pragmatic and positive critical thinking skills
- 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 GMP systems including PASx, eLIMs, Siemens, and SAP is preferred
- 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.