CMC Expert: Chemistry & Process Development (Hybrid)

Pierre Fabre Pharmaceuticals, Inc.; Toulouse; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Pierre Fabre shareholding

Health and provident insurance

16 days RTT + 25 days holidays

Public transport participation

Résumé du poste

Pierre Fabre Laboratories in Toulouse is seeking a CMC Expert on a permanent contract to develop and manufacturing of new drug candidates. You will lead CMC strategy, DS dossiers, and technology transfer while coordinating with cross-functional teams.

The role requires 10+ years in CMC, fluent English, and strong cGMP/regulatory experience, with CDMO leadership. Teleworking up to 2 days/week is possible under company rules.

Qualifications

• Minimum 10 years in CMC across several clinical studies (Phase 1–3).
• Fluent English essential; ability to interact with authorities.
• Extensive experience with cGMP and regulatory filings.
• Leadership of chemistry projects and cross-functional teams.

Responsabilités

• Propose CMC strategy and transcribe into dossier content.
• Sign CMC QOS and variations and liaise with authorities.
• Analyze analytics issues and coordinate corrective actions.
• Define and manage chemistry budget across development phases.
• Provide expert guidance to CMC subcontractors.

Connaissances

fluent English

cGMP experience

CDMO experience

Chemistry project management

Formation

Chemical engineer degree

PhD in Chemistry

Description du poste

Pierre Fabre Laboratories in Toulouse is seeking a CMC Expert on a permanent contract to develop and manufacturing of new drug candidates. You will lead CMC strategy, DS dossiers, and technology transfer while coordinating with cross-functional teams.

The role requires 10+ years in CMC, fluent English, and strong cGMP/regulatory experience, with CDMO leadership. Teleworking up to 2 days/week is possible under company rules.