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QA Supply Chain Coordinator, Manager - Mechelen, Nederland - Galapagos
Beschrijving
Pleased to meet you, we are Galapagos . 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 gene therapy manufacturing model (PoC) which offers efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. CellPoint currently has two products in Phase I/II clinical trials.
For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for a QA for Supply Chain Coordinator to join us in setting up, promoting and maintaining the QA model for CellPoint's dynamic business environment.
Scope of the role
As Oncology QA for Supply Chain Coordinator, you join our Quality Assurance team located in Leiden. We are a team of 11, but growing, building a QA model for our expanding organisation, working closely together with the point-of-care manufacturing partners and our internal partners inside and outside our Quality department. As the central site in this POC model, we oversee both central GxP activities, as well as CAR T-cell manufacturing close to patients. In this rapidly changing field, we're building a strong fundament to carry the next steps in clinical development of current and future products, as well as toward commercial launch.
At CellPoint/Galapagos, we strongly believe in the power of collaboration to achieve ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.
Responsabilities
The Oncology QA Supply chain Coordinator reports to the QA Oncology Point of Care Lead at Galapagos.
