Chemical Expert CMC -CDI- M/F

Job Overview

Pierre Fabre Laboratories is seeking a Chemical Expert for CMC on a permanent contract at its Toulouse site (Oncopole, 31). The role reports to the R&D Department and focuses on drug substance development and manufacturing of new drug candidates, including synthesis route selection, scale‑up, technology transfer, characterisation, and support for validation and specification definition.

Responsibilities

• Propose a pharmaceutical strategy in line with chemical expertise and translate it into dossiers as a CMC expert.
• Conduct CMC quality reviews (module3) of drug substance and project dossiers as an in‑house chemical expert.
• Provide chemical expertise during due diligence, analyse drug substance chemistry issues, and assess work required to resolve them.
• Carry out CMC work packages for new projects in cross‑functional teams (clinical, non‑clinical, research, regulatory, quality, etc.).
• Monitor work in terms of quality, cost and timeline with internal departments and subcontractors; provide expert support and scientific guidance to CMC outsourcing managers.
• Represent the company’s CMC chemistry expertise to regulatory authorities; draft or verify the quality module of drug‑substance sections in INDs, IMPDs, NDAs, MAAs, including authorities’ questions and answers.
• Define and manage the chemistry budget across all development phases; support internal lifecycle‑management programs and regulatory changes (nitrosamines reports, ethylene glycol, diethylene glycol, etc.).

Qualifications

• Chemical engineer or PhD in chemistry.
• Minimum 10years’ experience in CMC expertise acquired through several clinical studies (phase1 to3), ideally up to registration.
• Fluent English.
• Extensive experience in Good Manufacturing Practices (cGMP).
• CDMO management experience.
• Technical leadership in chemistry and project management associated with development programs.

Benefits

• Attractive remuneration and benefits package including incentives and profit‑sharing.
• Share‑holding scheme with matching contribution.
• Health and provident insurance.
• 16 days of public holiday (RTT) plus 25 personal days of holiday.
• Participation in public transport costs.
• Teleworking available up to 2 days a week according to company rules.

EEO Statement

At Pierre Fabre Laboratories, we believe that our greatest asset is our people. We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identifiably and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or otherwise participating in the application process. Thus, we commit to considering all applications equally, without fail.