Associate Bioanalytical Leader - 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), Basel (Switzerland) and in Boston (US).

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.

 

For our site of Romainville, we are looking for an

 

Associate Bioanalytical Leader

 

 

Within the Clinical Pharmacology department, you will be responsible to manage bioanalytical and in vitro ADME activities for Galapagos projects in clinical development.

 

Your principal accountabilities will be:

  • To manage bioanalytical support for quantification of NCEs, biomarkers, peptides, proteins to support projects in development
  • To manage in vitro DDI studies including communication of results and contribute to metabolites identification
  • To define study protocol, work plans, analytical methods and costs to fit project timelines and budget
  • To review and finalize the study data, study documentation and reporting
  • To monitor vendors performance to ensure study completion according to agreed quality standards, timelines and costs
  • To assist with compilation and documentation of relevant study documents to support successful IND or CTA filling
  • To keep up to date with relevant regulatory guidance and industry best practices

You will report to the Bioanalytical Leader and work in close collaboration with Clinical Pharmacology Leaders located on the different Development sites (Romainville, Mechelen and Leiden).

 

Requirements

Who are you?

  • Master or BS in chemistry, biology, biochemistry, pharmacy or equivalent qualification
  • First proven hands-on experience (3 to 5 years) in the Pharmaceutical /Biotech Industry or Contract Research Organizations in Bioanalysis and ADME activities.
  • Experience in metabolite structural identification via MS based technics.
  • Good understanding of relevant regulatory guidelines (e.g. GLP, GCP, CLIA, FDA, USDA, OECD) addressing bioanalytical and in vitro ADME support for clinical studies
  • Experience in placing and managing external work at CROs
  • Knowledge of Phoenix WinNonlin would be a plus
  • You have the capability to work as an expert and share your expertise with other team members. You know how to work independently and within a team. You are used to work in project mode, including with geographically distant teams.

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…!