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(Senior) Technician, Material Kitting Operations, Leiden, NL
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Pleased to meet you, we are CellPoint, a Galapagos company. We’re a dynamic fast growing Biotech company in the business of changing lives.
Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.
Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. For more information, please visit www.cellpoint.bio.
For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for a (Senior) Technician, Material Kitting Operations
Scope of the role:
We are seeking a (Senior) Technician, Material Kitting Operations to join the CellPoint Manufacturing team, supporting the GMP operations at the decentralized point-of-care manufacturing units and central facility in Leiden. The (Senior) Technician, Material Kitting Operations is a hands-on subject matter expert in GMP material kitting operations, being 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.
- 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.
The (Senior) Technician Material Kitting Operations reports to the Manager Manufacturing.
- BSc degree in biotechnology, supply chain logistics or related discipline
- Hands-on experience with pharmaceutical materials management, warehouse, logistics, packaging and distribution of GMP materials.
- Result-driven and can-do mindset, without compromising quality and compliance
- Good interpersonal skills and written and spoken fluency in English
- Team player and good communication
What’s in it for you?
You will be part of a fast growing and amazing company. As a ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.
We are Galapagos : together we can make it happen…!