CMC Chemistry Expert – Drug Substance Development (Hybrid)

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Hybride; EUR 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Incentives

profit-sharing

Pierre Fabre shareholding with match

health and provident insurance

16 days RTT + 25 days personal leave

Résumé du poste

Pierre Fabre Laboratories in Toulouse (Oncopole) seeks a Chemical Expert for CMC on a permanent contract. You will lead DS development, optimize synthesis routes, support scale-up, and manage technology transfer of the active.

The role requires 10+ years in CMC, English fluency, cGMP expertise, and experience with CDMOs; you will collaborate across clinical, regulatory, and quality teams and interact with authorities.

Qualifications

• PhD in chemistry or chemical engineering required.
• Minimum 10 years' CMC experience across several clinical studies (phase 1–3).
• Fluent English required.
• Extensive experience in cGMP.
• Experience managing a CDMO.
• Technical leadership in chemistry and project management for development programs.

Responsabilités

• Propose a pharmaceutical CMC strategy aligned with chemical expertise and document it in dossiers.
• Carry out CMC quality reviews (module 3) of DS and participate in due diligences.
• Analyze and appraise DS chemistry issues and define work to resolve them.
• Provide chemical expertise for internal requests and for CMC watch.
• Own the CMC Work Package for new projects, coordinating across clinical, non-clinical, research, regulatory and quality.
• Monitor work against strategy, ensuring quality, cost and timing.
• Represent Pierre Fabre's CMC chemistry to authorities if needed.
• Draft/check DS module sections for INDs/IMPDs/NDAs/MAAs, including Q&As.
• Define and manage the chemistry budget for development phases.
• Support lifecycle management and regulatory changes for assets and raw materials.

Connaissances

Chemical engineering

PhD in chemistry

English proficiency

cGMP experience

CDMO management

Project leadership

Formation

PhD in Chemistry

Chemical Engineering degree

Description du poste

Pierre Fabre Laboratories in Toulouse (Oncopole) seeks a Chemical Expert for CMC on a permanent contract. You will lead DS development, optimize synthesis routes, support scale-up, and manage technology transfer of the active.

The role requires 10+ years in CMC, English fluency, cGMP expertise, and experience with CDMOs; you will collaborate across clinical, regulatory, and quality teams and interact with authorities.