Haematology Therapy Manufacturing Specialist

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 Haematology Therapy Manufacturing 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

• 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

• 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)

• 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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