CMC Leader - Mechelen,BE

Job description

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 CMC Leader -  Mechelen,BE

 

Your role

You will manage the CMC activities according to the integrated project development -, CMC - and clinical plan for various compound development projects.

 

As a CMC Leader, you will be responsible for the CMC development strategy and execution thereof for various compound development projects.

 

This includes:

  • being the CMC project spokesperson for other departments/areas and interact with these
  • determining the CMC development strategy and development challenges with the CMC team
  • represent the CMC team in the Project team and Clinical Development team and align on strategy, planning and activities
  • ensure the CMC plan and strategy are executed according to plan
  • provide CMC budget information /update in line with the integrated development plan
  • acting as primary contact/spokesperson for interaction with competent authorities for CMC related topics (questions or meetings)
  • ensure  CMC source documents for clinical trial applications (quality section) are timely available and are properly stored / archived
  • interaction with other CMC team members (Analytical Leader, Drug product Leader,Drug Substance Leader, IMPD writer and Clinical supply Leader) to build the CMC development plan and ensure execution thereof
  • collaboration with internal Quality and Compliance department for project related quality topics.
  • adherence to existing Policies and Procedures and ensure timely completion of relevant training

Requirements

Who are you?

  • Master degree or PhD in chemistry, pharmaceutical sciences or bio-engineering or equivalent by experience
  • At least 5 years of working experience in a similar role
  • Ability to actively listen and engage in constructive communication with the different team members
  • Good organizational skills
  • Excellent team player
  • Excellence in planning, organising and supervising projects
  • Good communication skills, written and verbally, in Dutch and/or English

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…!