Senior CMC Expert – Drug Development Chemistry

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Sur place; EUR 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Shareholding

Health insurance

Holidays & RTT

Transport support

Résumé du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is seeking a senior CMC Expert for our Toulouse site (Oncopole). You will lead chemistry development, optimize synthesis routes, and support technology transfer for new drug candidates, collaborating with cross-functional teams.

Ideal candidates have a chemical engineering degree or PhD in chemistry, 10+ years in CMC, and fluent English. Teleworking up to 2 days per week is possible under company rules.

Qualifications

• Chemical engineer or PhD in chemistry with minimum 10 years' CMC experience across multiple clinical studies.
• Fluent English essential and extensive experience in cGMP.
• Experience managing a CDMO and leadership of chemistry development programs is required.
• Regulatory experience drafting INDs/IMPDs/NDAs/MAAs and related questions.

Responsabilités

• Propose a pharmaceutical strategy aligned with CMC expertise and ensure it is transcribed into dossiers.
• Sign QOS and variations requiring signed CMC expertise.
• Provide chemical, analytical and CMC support for development programs.
• Define and manage the chemistry budget across all development phases.
• Represent CMC to authorities and draft CMC sections of regulatory submissions.

Connaissances

CMC expertise

English fluency

Project leadership

Formation

PhD in Chemistry

Chemical Engineering

Outils

cGMP

Description du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is seeking a senior CMC Expert for our Toulouse site (Oncopole). You will lead chemistry development, optimize synthesis routes, and support technology transfer for new drug candidates, collaborating with cross-functional teams.

Ideal candidates have a chemical engineering degree or PhD in chemistry, 10+ years in CMC, and fluent English. Teleworking up to 2 days per week is possible under company rules.