GMP Production Technician Hoofddorp • SIRE Life Sciences

About the Company:
This company is a leader in advanced therapies, specializing in the development and production of innovative cell-based treatments. Their focus is on delivering life-changing therapies to patients while maintaining the highest quality standards in a regulated manufacturing environment.

Role Description:
As a Cell Therapy Technician/Specialist, you will be responsible for executing critical steps in the manufacturing of advanced therapies. Working in a GMP-compliant cleanroom environment, you will perform aseptic processing, material preparation, and product handling to support clinical and commercial cell therapy production. This role requires adherence to strict protocols and a keen attention to detail to ensure the highest quality standards.

Key Responsibilities:

• Execute cell therapy manufacturing processes in Grade A and B cleanroom environments following batch records and standard operating procedures (SOPs).
• Support production operations by preparing and transferring materials, media, and components to the manufacturing suites.
• Perform visual inspections, cryopreservation, and sample submissions for quality control.
• Maintain cleanroom conditions, ensuring compliance with GMP and safety standards.
• Accurately document processes and contribute to investigations related to deviations and process improvements.
• Assist in drafting and revising SOPs, batch records, and work instructions to maintain compliance.
• Troubleshoot processing and equipment issues as needed.
• Work collaboratively with cross-functional teams, including Quality, Supply Chain, and Process Development.

• MLO/MBO/HBO (equivalent to Associate’s or Bachelor’s degree) in Life Sciences, Biotechnology, or a related field.
• Experience in GMP-regulated manufacturing, preferably within pharmaceuticals, biotechnology, or cell therapy.
• Understanding of aseptic processing and cleanroom operations.
• Hands-on experience with biological sample handling, media preparation, and visual inspection is a plus.
• Ability to work in full gowning requirements and follow strict contamination control procedures.
• Strong attention to detail, compliance mindset, and ability to adapt in a fast-paced environment.
• Fluency in English (Dutch is not required).

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