Drug Product Development 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 Drug Product Development Leader -  Mechelen,BE

 

Your role

 

You will manage the drug product development and clinical bulk supplies for various development projects within the CMC department. As a Drug Product Development Leader, you will be responsible for:

  • the drug product development and bulk supply strategy and execution thereof for various development projects 
  • drug product – formulation development for preclinical safety studies and clinical supplies 
  • (bulk) manufacturing of development batches and GMP batches for clinical purposes 
  • evaluation and review of development data (composition/process/PK data) and adjustment of formulation/process as needed 
  • evaluation of stability data in cooperation with Analytical Leader and further adjustment of the strategy and plan as needed 
  • preparation of drug product development source documents for clinical trial applications (quality section) and prepare responses to regulatory questions 
  • selection and management of contractors executing the drug product development / manufacturing activities 
  • collaboration with internal Quality and Compliance department to assure that CRO’s are performing according to cGMP regulations
  • interaction with other CMC team members (CMC Leader, Analytical Leader and Drug Substance Leader) to build the CMC development plan and ensure execution thereof 

Requirements

Who are you?

  • PhD in pharmaceutical or bio-engineering or equivalent by experience
  • At least 5 years of experience in drug development, especially in formulation development and experienced in the preparation of drug product development reports for the CMC-section of a number of IND/IMPD or NDA submissions
  • Good understanding of the drug development process, management of network of CRO’s, work in cross functional teams 
  • Proficiency in all aspects of Microsoft applications

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…!