Technician Material Kitting Operations (Contractor)

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We are looking for a Technician Material Kitting Operations to join our Manufacturing team as a contractor for 6 months. 

Scope of the job

In this project, you support the GMP operations at the decentralized point-of-care manufacturing units and central facility in Leiden. You are a hands-on subject matter expert in GMP material kitting operations, responsible for hands-on preparation material kits and distribution to the clinical sites for production of CAR-T cell therapies at the point-of-care.

Your role

• Prepare GMP material kits in a cleanroom environment according to the standard operating procedures, ensuring timely supply to the decentralized point-of-care manufacturing sites for production of CAR-T cell therapies.
• Ensure robust and efficient kitting operations at the Leiden facility, supporting cleanroom/laboratory management, material ordering/organization, production scheduling and troubleshooting.
• Contribute to the improvement and automation of the overall material supply chain, including implementation of ERP system, supporting QC incoming goods, warehouse management and material logistics as needed.
• Contribute to electronic batch records, SOPs, protocols & reports, ensuring the materials are adequately stored, shipped and used according to the GMP requirements.
• Contribute to continuous improvements to the kitting process, material packaging, addition of second source suppliers.
• Support root-cause investigations for deviations, determine corrective actions and support implementation of change controls related to materials and kitting.
• Supporting manufacturing activities such as laboratory runs, process training, process qualification and aseptic process validation as required.

You will interact with members of operational teams at all levels for alignment on activities relating to material management, and central site operations. Within the Manufacturing team, you align with (Sr) Process Engineers and Line Management on any topics relating to compliance and quality to ensure appropriate follow up.