Senior CMC Chemist — DS Development & Tech Transfer (Remote)

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

Benefits offered by this job

Incentives

Profit-sharing

Shareholding with matching

Health and provident insurance

25 days personal holidays

RTT 16 days plus holidays

Job summary

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.

Responsibilities

• 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.

Skills

Chemical engineering

PhD in chemistry

Fluent English

cGMP experience

CDMO experience

Project management

Leadership

Education

PhD in Chemistry

Chemical engineering degree

Job description

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.