- - Galapagos is hiring a

Project manager Site Management - Contractor (12 months), US

Leiden, Netherlands
Contractor

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 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. We bring 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 the Galapagos organization in the United States, we are looking for a highly motivated Project Manager to join our team in a 12-month contractor role.


Scope of the project


We are seeking a highly motivated Project Manager to join the Site Management team. The role is located in the US, ideally in the New York or New Jersey area, and is part of the US entity of Galapagos. The Project Manager will be actively engaged in the selection of decentral manufacturing units, assessing the sites facility and requirements applicable to support the company’s pioneering Decentralized Manufacturing model, and will be responsible for coordinating the subsequent start-up and technology transfer activities. The Project Manager is the key contact person for the manufacturing site during site selection and technology transfer and will work with a cross-functional team at Galapagos to drive the project.


Your mission

  • Participation in site selection from a Tech Ops perspective, involved in:
    • Assessment of the manufacturing facility and capabilities of a potential partner site, including site visits
    • Generation of Gap assessment reports and recommendations to proceed to Tech Transfer
  • Act as project manager during the start-up and tech transfer phases by:
    • Coordinating equipment deployment and IOQ to the sites
    • Generation of the Tech Transfer Plan, maintenance of and oversight on the tech transfer planning
    • Facilitating Project Team Meetings between Galapagos and the Decentralized Manufacturing teams including minutes and follow-up on actions defined during these PTMs
    • Reporting project status and timely escalation of changes and/or constraints to Site Management team
  • Liaison with the Decentralized Manufacturing sites:
    • Maintain relationship
    • Monitor the manufacturing facility during clinical manufacturing operations
    • Coordinate change where necessary (e.g. new product introduction, ramp up manufacturing rate)
  • Support the writing of procedures, deviations, change controls and CAPAs where appropriate
Apply for this job

Please mention you found this job on AI Jobs. It helps us get more startups to hire on our site. Thanks and good luck!

Get hired quicker

Be the first to apply. Receive an email whenever similar jobs are posted.

Ace your job interview

Understand the required skills and qualifications, anticipate the questions you may be asked, and study well-prepared answers using our sample responses.

Project Manager Q&A's
Report this job
Apply for this job