Scale-Up Analytical Development Leader (CMC) - Romainville

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 Scale-Up Analytical Development Leader (CMC)

                                               

Scope of the job

 

Within the CMC department and reporting to the Scale-Up Director, the Scale-Up Analytical Development Leader is responsible for the development, the qualification and the transfer of analytical methods for the testing of the early, non-GMP batches of Drug substance. He / she performs analysis experiments and data interpretation.

The core purpose of the job is to ensure quality and timely delivery of the analytical methods at very early stage of the development.

 

Your role

 

  • Develop appropriate UPLC analytical methods for new chemical entities or intermediates in collaboration with the development chemists and analysts
  • Ensure qualified methods are available for testing of the first Drug Substance batches
  • Perform analysis experiments and data interpretation
  • Contribute to structural elucidation of impurities using LC-MS, NMR…
  • Perform limited forced degradation studies on the compound to support an initial retest period, and storage condition claim
  • Work with Analytical Development Leader to support early activities within Drug substance CRO’s
  • Support CMC Analytical team with providing a relevant technical package for the transfer   
  • Write related documentation such as progress reports, technical documents or certificate of analysis
  • Maintain up to date scientific and technical skills - Ensure the maintenance of the equipment and instruments

#LI-LB1

Requirements

Who are you ?

 

Ph.D. in Analytical Chemistry + 5 years of experience or M.Sc. in Analytical Chemistry + 8 years of experience (HPLC method development, ideally in a pharmaceutical environment).

  • Strong analytical knowledge and practical expertise focused on LC-MS (TOF) and NMR
  • Good knowledge of organic chemistry
  • Data gathering, problem solving and analytical thinking skills
  • Fluent in English (speaking and writing)
  • Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success
  • Strong interpersonal and communication skills.
  • Exemplary teamwork, organizational and self-management skills. - Computer skills and proficiency in the required software’s (MS Office, Chem Draw, Isis draw, MassLynx, UNIFI…). 

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…!