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Director Point-of-Care Operations, 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 Point-of-Care Operations.


Scope of the role:

We are seeking a Director Point-of-Care Operations to join the CellPoint Manufacturing organization, providing operational and strategic leadership to drive an expanding global network of decentralized point-of-care manufacturing units for CAR-T cell therapy. The Director Point-of-Care Operations will build and lead a team of manufacturing managers, engineers and technicians responsible for global GMP operations, including clinical manufacturing, technology transfers, technical support, training, APV and material management.


Responsibilities:

  • Lead the CAR-T manufacturing operations at the decentralized point-of-care manufacturing sites in EU, US and other regions, ensuring short vein-to-vein timelines to the patients and expansion of the manufacturing network.
  • Oversee day-to-day clinical manufacturing activities at the decentralized sites, ensuring consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform.
  • Lead execution of technology transfer activities at the decentralized point-of-care manufacturing sites, including equipment qualification, production training, aseptic process validation, process qualification runs, operational readiness.
  • Lead a 24/7 global technical support service for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.
  • Lead Aseptic Process Validation (APV) and Aseptic Operator Qualification (AOQ) strategy, planning and execution. Lead production training, providing onsite and remote training to production personnel at the decentralized sites.
  • Lead elaboration of electronic batch records, SOPs, protocols, risk assessments, position papers, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
  • Lead preparation of GMP material kits in a cleanroom environment at the central Leiden facility, ensuring timely material supply to the sites.
  • Support Process Validation lifecycle activities, through the stages of process design, process qualification and continued process verification. Support in authoring and review of regulatory filings and health authority questions related to technical process/CMC.
  • Support initiatives of operational excellence in the decentralized network of point-of-care manufacturing sites, production capacity modelling, automation/digitalization, production scheduling, cost of goods analysis, lean manufacturing, six sigma, data management, process/product monitoring, 5S, Kanban, etc.

The Director Point-of-Care Operations to the Head of Manufacturing.

Job requirements

  • BSc/MSc degree in life sciences, biotechnology, engineering or related discipline
  • 10+ years' experience, including extensive people management experience
  • Experience with management of contract manufacturing organizations
  • Experience with GMP manufacturing, technology transfers, process validation, cell & gene therapy processes, automated bioreactors, regulatory inspections.
  • 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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