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Galapagos zoekt een

Project Manager - Contractor, Leiden

's-Graveland, Netherlands

Job description

Pleased to meet you, we are Galapagos and 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. Galapagos brings a novel, decentralized 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.glpg.com .


Scope of the role

We are seeking a highly motivated Project Manager to join as contractor the EU Site Management team in the Leiden Bio Science Park. The Project Manager will be involved in the technical assessment of pre-selected manufacturers (CDMOs or bloodbanks), assessing the sites facility and licenses applicable to support Galapagos’ Decentral 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.

Responsibilities

  • 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
    • Assessment of the GMP readiness (e.g. licenses in place and required licenses to obtain)
    • Providing site management team with the relevant information to enable well considered site selection including sequence, based on feasibility and capabilities
  • Act as project manager during the start-up and tech transfer phases by:
    • Coordinating and support of implementation of the applicable licenses
    • Coordinating equipment deployment and IOQ to the sites
    • Generation of, maintenance of and oversight on the tech transfer planning
    • Facilitating Project Team Meetings between CellPoint and the Point of Care 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 Point of Care 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)
  • Write procedures, deviations, change controls and CAPAs where appropriate

Job requirements

Who are you ?

  • MSc of PhD degree in life sciences, biotechnology, or related discipline
  • Strong and proven Project Management skills, including the capability to work with and develop tools to monitor and report on project status (e.g. SmartSheet, MS Project)
  • Experienced in working with Contract Manufacturing Organisations in pharmaceuticals/biotech
  • Knowledgeable on the CMC requirements applicable to ATMPs in clinical phase and beyond
  • Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements, preferably within the field of gene therapy and ATMPs
  • Be aware of the needs and perspectives of a Point-of-Care manufacturing site to translate these into well developed digitalized (training and support) systems
  • Strong interpersonal, verbal and written communication skills
  • Ability to be flexible with changing priorities
  • Self-driven and can-do mindset, without compromising quality
  • Fluent in English

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