CMC Expert M/F

We are recruiting a CMC Expert on a permanent contract for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Medical Care's R&D Department

You will be responsible for the 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, validation of development activities for validation, definition of specifications and validation of processes.

Your role within a pioneering company in full expansion:

• Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a CMC expert. Carry out CMC quality reviews (module 3) of product and project dossiers as an in-house expert, and provide chemical expertise as part of Due Diligences.
• You sign QOS and variations requiring signed CMC expertise (1.4.1).
• Analyze and appraise product issues relating to analytics, and assess the work required to resolve them.
• Provide chemical expertise (analytical and CMC) 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 subcontractors.
• Represent Pierre Fabre's CMC expertise to the authorities in case of questions. You draft and/or check the CMC 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 lifecycle management programs and regulatory changes for assets and raw materials (i.e. nitrosamines report assessment, ethylene glycol and diethylene glycol assessment, regulatory changes...).

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package:

• Incentives
• profit-sharing
• Pierre Fabre shareholding with matching contribution
• health and provident insurance
• 16 days of holidays (RTT) in addition to 25 days of personal holidays
• public transport participation
• very attractive CE...

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 essentialExtensive 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.