Chemical Expert CMC -CDI- M/F

Pierre Fabre; Toulouse; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Shareholding with matching

Health and provident insurance

25 days personal holidays

RTT 16 days plus holidays

Résumé du poste

Pierre Fabre is seeking a Chemical Expert for CMC at its Toulouse site (Oncopole). You will lead DS development, process optimization, scale-up, technology transfer, and specification definition to support INDs/NDAs/MAAs.

Reporting to the R&D Department, you will provide chemical expertise across development phases, manage budgets, interact with clinical, regulatory, quality and external CMOs, and represent CMC chemistry to authorities as needed. Fluent English and cGMP experience are essential.

Qualifications

• Chemical engineer or PhD in chemistry with 10+ years in CMC.
• Fluent English and strong knowledge of cGMP.
• Experience leading chemistry projects and interacting with authorities.

Responsabilités

• Propose a pharmaceutical CMC strategy and transcribe it into dossiers.
• Carry out DS module 3 quality reviews and provide chemical expertise.
• Analyze DS chemistry issues and plan resolutions with cross-functional teams.
• Own the CMC Work Package for new projects and monitor progress with internal and external partners.
• Provide guidance to CMC OutSourcing Managers and represent CMC chemistry to authorities.
• Draft/verify quality modules for DS parts of INDs/IMPDs/NDAs/MAAs and manage budgets.
• Support lifecycle management and regulatory changes for assets and raw materials.

Connaissances

Chemical engineering

PhD in chemistry

Fluent English

cGMP experience

CDMO experience

Project management

Leadership

Formation

PhD in Chemistry

Chemical engineering degree

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 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...# Qui êtes-vous ?**Your skills at the service of innovative projects:**Chemical engineer or PhD in chemistryMinimum 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 CDMOExperience of technical leadership in chemistry and project management associated with development programs is required.