Drug Substance Development Leader - Mechelen, BE or Romainville, FR

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) and in US, Boston.

 

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 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: The ‘make-it-happeners’. 

 

We are looking for a Drug Substance Development Leader.

                                                

Scope of the job

 

As Drug Substance Development leader within CMC, you will be responsible for the Drug Substance (API) development and up-scaling strategy and execution thereof for various development projects.

 

This includes:

  • Developing drug substance synthesis including the solid state
  • Manufacturing of non-GMP and GMP batches and upscaling 
  • Identifying and synthetizing related impurities
  • Performing mutagenic impurity assessment in collaboration with pre-clinical safety representatives and as needed with Analytical Development leader
  • Preparing, reviewing, approving Drug substance source documents related to clinical trial applications and contributing to responses to Drug Substance related regulatory questions
  • Selecting and managing of external service providers (CROs and CDMOs) for the  DS development / manufacturing activities in alignment with Head Drug Substance Development and in collaboration with purchasing team
  • Collaboration with internal Quality and Compliance department to assure that External providers are performing according to cGMPs
  • Being a member of and actively contribute to the various CMC teams for assigned projects
  • Interacting with other CMC team members to build the CMC development plan and ensure execution thereof
  • Interacting with members of the Scale up team to ensure timely transfer of technical/chemical package 

 #LI-LB1

Requirements

Who are you ?

 

The successful candidate has a PhD in organic chemistry and at least 5 years of experience in drug development, especially in drug substance development/upscaling area. 

Good understanding of drug development process, management of network of CRO’s, work in cross functional teams is an important asset for this function.  He or she is experienced in the preparation of drug substance development reports for the CMC section of a number of IND/IMPD or NDA/MAA submissions. The candidate has strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations. 

 

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 interity 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…!