CMC Chemistry Expert: DS Development & Regulatory Lead

Laboratoires Pierre Fabre; Toulouse; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Incentives

Profit-sharing

Pierre Fabre shareholding

Health insurance

Provident insurance

Job summary

Laboratoires Pierre Fabre in Toulouse is seeking a Chemical Expert for CMC on a permanent contract. You will lead DS development and manufacturing for new drug candidates, including selection of synthesis routes, scale-up, tech transfer, and DS impurity characterization.

The role requires drafting quality modules for regulatory submissions and collaborating across clinical, regulatory, and quality teams. You will drive the CMC strategy, manage budgets, and provide expert guidance to outsourcing

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).
• Experience of managing a CDMO.
• Experience of technical leadership in chemistry and project management associated with development programs.

Responsibilities

• Develop and manufacture drug substance (DS); optimize small molecule synthesis routes and tech transfer.
• Support scale-up, process validation and DS characterization of impurities and RSMs.
• Lead CMC strategy, prepare module 3 quality reviews and DS portions of regulatory dossiers (INDs/IMPDs/NDAs/MAAs).
• Define and manage chemistry budget across development phases.
• Provide scientific guidance to CMC Outsourcing Managers and interact with authorities as needed.

Skills

CMC expertise

GMP / cGMP

Project management

Technical leadership

Regulatory knowledge

Education

Chemical engineer

PhD in chemistry

Job description

Laboratoires Pierre Fabre in Toulouse is seeking a Chemical Expert for CMC on a permanent contract. You will lead DS development and manufacturing for new drug candidates, including selection of synthesis routes, scale-up, tech transfer, and DS impurity characterization.

The role requires drafting quality modules for regulatory submissions and collaborating across clinical, regulatory, and quality teams. You will drive the CMC strategy, manage budgets, and provide expert guidance to outsourcing