Associate Director Site Management, NJ/US

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the 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 Galapagos in Princeton/US, we are looking for an Associate Director Site Management

Scope of the role:

We are looking forward to welcoming an Associate Director Site Management for the US to join the Manufacturing Site Management team. The role is based in our Princeton offices. The Associate Director is responsible for setting up, expanding and managing the US-based Site Management team and plays a pivotal role in further developing the cross-functional US-based Galapagos team to build-out the Decentralized Manufacturing network. Additionally, the Associate Director is responsible for the selection of the decentral manufacturing units, assessing the sites facility and requirements applicable to support the Decentralized Manufacturing model, and coordinates the subsequent start-up and technology transfer activities. This role is the key contact for the manufacturing site during site selection and technology transfer, manages project budgets and installs new Statements of Work associated with project changes.

Your role

• Expanding, leading and managing the US-based Site Management Team
  • Coordinate hiring of new team members, together with the Head of Site Management
  • Act as team lead and manager of the US Site Management Team
  • Actively participate in setting up and collaborate with the cross-functional Galapagos teams in the US
  • Install new Statements of Work including budget alignments where applicable
• Participation in site selection from a Technical Operations 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:
  • Generation of the Tech Transfer Plan, maintenance of and oversight on the tech transfer planning
  • Coordinating equipment deployment and IOQ to the sites
  • Facilitating Project Team Meetings between various Cell Therapy teams 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
  • Coordinate change where necessary (e.g. new product introduction, ramp up manufacturing rate, implementation of improvements)
• Write procedures and Change Controls where appropriate

• MSc of PhD degree in life sciences, biotechnology, or related discipline
• At least 7 years of experience in working with(in) Contract Manufacturing Organizations in pharmaceuticals/biotech
• Having a strong business mindset to negotiate budgets and implement Statements of Work
• Strong and proven Project Management skills, including the capability to work with and develop tools to monitor and report on project status (e.g. EPPM, MS Project)
• 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
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Ability to travel
• 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 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, 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 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…!