Project Manager PoC Manufacturing Site Management

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 gene therapy manufacturing model which offers efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. CellPoint currently has two products in Phase I/II clinical trials. For more information, please visit www.cellpoint.bio.


For the CellPoint/Galapagos organisation in Leiden/NL, we are looking for a Project Manager to join the PoC Manufacturing Site Management team in the Leiden Bio Science Park.


The Project Manager is involved in the selection of the clinical centres of excellence, assessing the sites facility and licenses applicable to support the Point-of-Care Manufacturing model, and takes ownership of the coordination of 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, but also contributes to optimizing the site selection and technology transfer processes by assessing and revising project content, information packages and training (e.g. slide decks, training programs and documents). Additionally, the Project Manager participates in the development and implementation of the site training (Learning Management System) and support systems, to provide future proof and scalable solutions to our Point-of-Care manufacturing sites.

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
  • Create, maintain, and continuously improve (training) materials required for site initiation and start up

Job requirements

  • MSc or 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
  • Awareness 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


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…!


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