Chemical Expert CMC

Chemical Expert CMC

Pierre Fabre

Toulouse, France

Your mission

You will be responsible for the drug substance (DS) development and manufacturing of new drug candidates. This includes selection and optimization of small molecule synthesis routes, manufacturing support, scale-up process and technology transfer of the active, characterization of RSM and impurities, development activities to support validation, definition of specifications and process validation.

Your role within a pioneering company in full expansion:

More specifically, you will:

• Propose a pharmaceutical strategy in line with its chemical expertise and ensure that it is transcribed into dossiers as a CMC expert. Carry out CMC quality reviews (module 3) of DS and project dossiers as an in-house chemical expert and provide chemical expertise as part of Due Diligences.
• Analyze and appraise DS issues relating to chemistry, and assess the work required to resolve them.
• Provide chemical expertise for all requests, as well as technological and CMC watch. You are responsible for the CMC Work Package for new projects, in cross-functional collaboration with clinical, non-clinical, research, regulatory, quality and other departments.
• You will be responsible for monitoring work in line with this strategy, in terms of quality/cost/timeframe, with internal departments and subcontractors, and will provide expert support and scientific guidance to CMC OutSourcing Managers (OSM).
• Represent Pierre Fabre's CMC chemistry expertise to the authorities in case of questions. You draft and/or check the quality module for DS parts of INDs/IMPDs/NDAs/MAAs, including questions and answers to the authorities.
• Define and manage the chemistry budget for all development phases.
• Support as chemistry expert internal life cycle management programs and regulatory changes for assets and raw materials (i.e. nitrosamines report assessment, ethylene glycol and diethylene glycol assessment, regulatory changes...).

Who you are?

Your skills at the service of innovative projects:

• Chemical engineer or PhD in chemistry.
• Minimum 10 years' experience in CMC expertise acquired through several clinical studies (phase 1 to phase 3), ideally up to registration.
• Fluent English essential.
• Extensive experience in Good Manufacturing Practices (cGMP).
• You have managed a CDMO.
• Experience of technical leadership in chemistry and project management associated with development programs is required.