Haematology Therapy Manufacturing Specialist

This is a vacancy for a Haematology Therapy Manufacturing Specialist at 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. 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 for the 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.

Key Responsibilities for the 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.