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.
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
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.
Tagged as: Scale-Up Analytical Development Leader (CMC) - Romainville
Main Duties: Working in the Quality Assurance Department and will be involved in the following activities: Master Batch Record process...Apply For This Job
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