Clinical Supplies Leader - Mechelen,BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in US (Boston).
We are 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 want to challenge the impossible. 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.
We are looking for a Clinical Supplies Leader - Mechelen,BE
You will manage clinical supply chains (mainly from Phase II on) involving Investigational Medicinal Product (IMP), active comparators and matching placebo to ensure uninterrupted drug supply throughout the clinical study at sites worldwide and according to the integrated project development -, CMC - and clinical plan.
- Be member of and actively contribute to the various CMC teams and Clinical Study teams
- Develop and manage the “Clinical Study Supply Plan” in collaboration with the clinical study team from availability of bulk clinical study supplies till final return/destruction of clinical study supplies
- Ensure the clinical study supply plan and activities are in compliance with governing SOP’s, GxP requirements and regulations
- Select (in alignment with Head Clinical Supply) and manage Clinical Supply vendors, including contract negotiation and budget follow up
- Forecast the demand of the different IMPs and non-IMPs for the clinical development program both initially and on an ongoing basis throughout the clinical development program
- Make proposals for suitable kit design based on the clinical study design and create Master labels
- Contribute to RTSM set up by advising on site and depot supply and resupply parameters; Monitor inventory levels based on vendor and RTSM reports
- Ensure clinical supplies source documents for clinical trial applications (quality section) are timely available and are properly stored / archived
- Collaborate with internal Quality department to manage complaints and deviations related to IMP and follow-up on overall compliance of Clinical Supply vendors.
- Ensure that the Product Specification File for the clinical supply activities is kept up to date
Who are you?
- Master degree in sciences or bio-engineering and first experience in life science, packaging, labeling or supply chain
- Ability to actively listen and engage in constructive communication with the different team members
- Good organizational skills
- Excellent team player
- Excellence in planning, organizing and supervising projects
- Good communication skills, written and verbally, in English. Dutch, French or German a plus
- Knowledge of relevant regulations GxP
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…!