Scale-Up Analytical Development Leader (CMC) - Romainville

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Irfa******

  • France 
  • Last Update: 28.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Romainville, FR
Country
France

Category


Research & Development (R&D)

Description


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

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