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Director Manufacturing Sciences and Technology (MSAT), Leiden, NL

Manufacturing

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Job description

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 Director Manufacturing Sciences and Technology (MSAT).


Scope of the role:

We are seeking a Director Manufacturing Sciences and Technology (MSAT) to join the CellPoint team in the Leiden Bio Science Park, The Netherlands. The Director MSAT will provide technical and strategic leadership to drive CAR-T processes/products from early clinical stage through pivotal/commercial readiness. The Director MSAT will build and lead a team of process engineers, scientists and technicians, providing technical/scientific support to the GMP operations in a global network of point-of-care manufacturing units, including technology transfers, clinical manufacturing and scale-out.

Responsibilities:

  • Lead the overall Process Validation lifecycle from strategy, planning, execution and reporting, through the stages of process design, process qualification and continued process verification. Lead strategy for process and product comparability.
  • Review and lead content of regulatory filings and health authority questions related to technical process/CMC.
  • Lead 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.
  • Lead design/execution of process characterization, late-stage development, comparability, development studies, scale-down model development/qualification at the central facility in Leiden.
  • Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform. Oversee development of electronic batch records, SOPs, protocols.

The Director MSAT reports to the Head of Manufacturing.

Job requirements

  • MSc/PhD degree in life sciences, biotechnology, or related discipline
  • 10+ years of experience, including people management
  • Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA)
  • Experience with process validation, process development, cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfers
  • Strong interpersonal, verbal and written communication skills
  • Ability to be flexible with changing priorities
  • Result-driven and can-do mindset, without compromising quality and compliance
  • 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.

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We are Galapagos : together we can make it happen…!

 

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We’re in the business of changing lives. In our quest to discover, develop and deliver life-improving medicines, we go where no one has ever gone before.

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