Chemical Expert CMC

Pierre Fabre Laboratories; Toulouse; Hybride; EUR 90 000 - 150 000; Plein temps

Résumé du poste

Pierre Fabre Laboratories in Toulouse (Oncopole, 31) is seeking a Chemical Expert for CMC on a permanent contract, reporting to the R&D Department. You will lead DS development, optimize small molecule synthesis routes, manage tech transfer, and define specifications, with responsibility for chemistry budget and interactions with regulatory authorities.

The role requires a chemical engineer or PhD in chemistry, 10+ years in CMC, extensive cGMP experience, and proven CDMO leadership, with ability

Qualifications

• 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.
• 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.

Responsabilités

• 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...).

Connaissances

CMC expertise

CDMO management

Project management

cGMP knowledge

Chemical engineering

Formation

Chemical Engineer degree

PhD in chemistry

Description du poste

We are recruiting a Chemical Expert for CMC 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 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...).

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...

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.

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.