Project Lead EU Site Management, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

For the Galapagos organisation in Leiden, The Netherlands, we are looking for a Project Lead EU Site Management

Scope

We are seeking a highly motivated Project Lead to join the EU Site Management team for our Cell Therapy department in the Leiden Bio Science Park. The Project Lead technically assesses pre-selected manufacturers (CDMOs or blood banks), focusing on the sites’ facility and licenses applicable to support Galapagos’ Decentralized Manufacturing model, and is responsible for coordinating the subsequent start-up and technology transfer activities. Our new colleague is the key contact person for the manufacturing site during site selection and technology transfer, bringing expertise and operational capacity together to successfully launch new manufacturing partners for Galapagos in decentralized CAR-T cell therapy

Your role

• 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 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 relationships.
  • 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.

This position reports to the Head EU Site Management in Leiden and requires occasional travel.

• 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
• Experienced in working with Contract Manufacturing Organizations in pharmaceuticals/biotech, preferably focusing on tech transfers
• 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 cell or gene therapy and ATMPs
• Be aware of the needs and perspectives of a decentralized 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, German is a plus

What’s in it for you?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

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