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(Senior) Scientist, Process Sciences, 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) Scientist, Process Sciences
Scope of the role:
We are seeking a (Senior) Scientist, Process Sciences to join CellPoint Manufacturing Sciences and Technology (MSAT), providing technical-scientific expertise on the development of the next generations of automated CAR-T processes using the Cocoon platform. The (Senior) Scientist, Process Sciences will lead process characterization studies, late-stage process development/design, comparability, development studies, scale-down model development/qualification through the first stage of the Process Validation lifecycle, and further process qualification and continued process verification.
- Lead Process Characterization & Process Design activities for the CellPoint automated CAR-T processes in the Cocoon including strategy, planning, execution and reporting, through the first stage of the Process Validation lifecycle, and further process qualification and continued process verification.
- Lead Process and Product Comparability including strategy, planning, execution and reporting.
- Lead design/execution of process characterization studies, late-stage development, comparability, development studies, scale-down model development/qualification at the central facility in Leiden.
- Supervise/mentor technicians during the execution of Cocoon runs and small-scale experiments during process characterization activities.
- Review and lead content of regulatory filings and health authority questions related to technical process/CMC.
- Provide technical/scientific support to the GMP operations in a global network of point-of-care manufacturing units, including technology transfers, clinical manufacturing, scale-out.
- Support elaboration of process descriptions, process/product risk assessments, position papers, process/product impact assessments, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
The (Senior) Scientist, Process Sciences reports to the Director MSAT.
- MSc/PhD degree in life sciences, biotechnology, or related discipline
- 5+ years work experience
- Experience with process development, process characterization, process validation, cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfers
- Knowledge of data management tools, statistical process controls, design of experiments (DoE), Quality by Design (QbD)
- Result-driven and can-do mindset, without compromising quality and compliance
- Responsibility for own projects while pursuing company goals in open collaboration
- Good interpersonal skills and written and spoken fluency in English
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…!