About the Company
An international biotechnology organization active in cell therapy for oncology treatments. The company operates a highly regulated GMP manufacturing facility in Hoofddorp, closely connected to global hospital networks to process patient-derived cellular products for clinical and commercial use.
Role Description
As a Cell Therapy Specialist, you will support the manufacturing of autologous cell therapy products in a GMP cleanroom environment. After completing the initial training program, you will be assigned to either the Production Team (PT) or the Production Support Team (PST). This is a hands-on, operational role with a strong focus on aseptic processing, documentation accuracy, and compliance.
The position follows a two-shift system, including weekends, and requires working in full gowning within Grade A/B/C cleanroom environments.
Key Responsibilities
Production Support Team (PST)
- Perform apheresis material accessioning and transfer to manufacturing areas
- Prepare growth media in Grade C cleanroom environments
- Supply manufacturing suites with required materials and components
- Perform material decontamination prior to cleanroom entry
- Manage batch documentation flow to and from cleanroom nests
- Support batch record review to ensure timely release
- Perform visual inspection of final product
- Cryopreserve excess cells and final product
- Transfer and submit samples to QC for testing
Production Team (PT)
- Execute clinical and commercial manufacturing steps in Grade A/B cleanrooms according to batch records and SOPs
- Support GMP runs in collaboration with PST, Product Sciences, QA, QC, and Material Management
- Draft and revise batch records, SOPs, and work instructions
- Support deviation investigations and change management activities
- Troubleshoot process- and equipment-related issues
- Ensure strict compliance with cGMP requirements and accurate documentation
- Maintain cleanroom nests in an optimal state
- Identify opportunities for process improvements to enhance quality and efficiency
Working Conditions
Two-shift system:
- Morning: 07:00 – 15:00
- Evening: 16:30 – 23:30 / 00:00
- Weekend shifts included
- On-site role
- Full cleanroom gowning required
- Training period of approximately 2 months (day shift)
- Working with blood-derived biological materials (hepatitis B vaccination recommended)
Requirements
- Vocational / technical education (MBO level or equivalent); maximum completed level: BSc
- Experience in a GMP-regulated manufacturing environment (biotech, pharma, medical devices)
- Knowledge of pharmaceutical or biotechnology manufacturing processes
- Comfortable working in aseptic cleanroom environments
- Strong attention to detail and ability to strictly follow SOPs
- Willingness to work shift schedules, including weekends
- Professional working proficiency in English
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