Senior CMC Chemistry Expert for Drug Substance Development

Pierre Fabre Pharmaceuticals, Inc.; Toulouse; Hybrid; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Profit-sharing

Health insurance

Provident insurance

Shareholding with matching

Public transport allowance

16 RTT days + 25 personal holidays

Job summary

Pierre Fabre Laboratories is seeking a Chemical Expert for CMC at our Toulouse site (Oncopole) to drive drug substance development and manufacturing for new candidates. You will optimize synthesis routes, support scale‑up, and ensure robust technical transfer, while aligning with quality and regulatory expectations.

The role requires a PhD in chemistry, 10+ years in CMC across multiple clinical stages, and fluent English.

Qualifications

• PhD in chemistry required; strong chemical development background.
• Extensive cGMP experience with drug substance development.
• Experience leading cross‑functional teams and CMC strategies.

Responsibilities

• Lead DS development and manufacturing strategy for new candidates.
• Own CMC work packages across development, from phase 1 to 3.
• Provide chemical expertise for dossiers and regulatory interactions.
• Draft and review CMC modules for INDs/NDAs/MAAs and Q&A with authorities.
• Monitor project scope, budget and timelines with internal and external partners.

Skills

Chemical engineer

PhD in chemistry

Fluent English

cGMP experience

Project management

CDMO experience

Education

PhD in chemistry

Job description

Pierre Fabre Laboratories is seeking a Chemical Expert for CMC at our Toulouse site (Oncopole) to drive drug substance development and manufacturing for new candidates. You will optimize synthesis routes, support scale‑up, and ensure robust technical transfer, while aligning with quality and regulatory expectations.

The role requires a PhD in chemistry, 10+ years in CMC across multiple clinical stages, and fluent English.