CMC Expert – Pharmaceutical Chemistry

About the role

We are looking for a CMC Expert to join our R&D department in Toulouse. You will lead the development and manufacturing of new drug candidates, overseeing synthesis routes, scale‑up, and technology transfer.

Key responsibilities

• Define and implement CMC strategy, prepare and review CMC sections of regulatory dossiers (IND, IMPD, NDA, MAA).
• Lead the CMC work package for new projects, coordinating with clinical, regulatory, quality and external CDMOs.
• Sign off QOS and variations requiring CMC expertise, and represent the company before authorities.
• Manage chemistry budgets, support lifecycle management and regulatory change assessments.

Required profile

• PhD in Chemistry or Chemical Engineering with at least 10 years of CMC experience across clinical phases 1‑3.
• Fluent English and extensive knowledge of cGMP.
• Proven experience managing CDMOs and leading technical chemistry projects.

Required skills

• Small‑molecule synthesis route design and optimization.
• Process scale‑up and technology transfer.
• Characterisation of related substances and impurities.
• cGMP compliance and CDMO management.
• Project management in pharmaceutical development.

What we offer

• Attractive remuneration with incentives, profit‑sharing and shareholding.
• Health and provident insurance, 16 RTT days plus 25 vacation days.
• Public transport participation and a very attractive CE.
• Hybrid work model with up to two remote days per week.