Senior CMC Expert - Strategy, Dossiers & Tech Transfer

Pierre Fabre Laboratories; Toulouse; Hybride; EUR 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Shareholding with matching

Health insurance

Provident insurance

16 days RTT + 25 personal holidays

Public transport participation

Résumé du poste

Pierre Fabre Laboratories in Toulouse (Oncopole) seeks a CMC Expert on a permanent contract to lead development and manufacturing strategies for new drug candidates. You will define CMC strategy, carry out module 3 quality reviews of product and project dossiers, sign QOS/variations, and oversee CDMO management and regulatory submissions.

You will ensure technical leadership across chemistry and development programs and monitor budgets.

Qualifications

• Chemical engineer or PhD in chemistry.
• Minimum 10 years experience in CMC expertise through several clinical studies (phase 1 to phase 3), ideally up to registration.
• Fluent English essential.
• Extensive experience in cGMP (Good manufacturing Practices).
• You have managed a CDMO.
• Experience of technical leadership in chemistry and project management associated with development programs is required.

Responsabilités

• Propose a pharmaceutical strategy in line with CMC expertise and ensure it is transcribed into dossiers as a CMC expert.
• Carry out CMC quality reviews (module 3) of product and project dossiers as an in-house expert, and provide chemical expertise as part of Due Diligences.
• Sign QOS and variations requiring signed CMC expertise (1.4.1).
• Analyze and appraise product issues relating to analytics, and assess the work required to resolve them.
• Provide chemical expertise (analytical and CMC) for all requests, and oversee CMC watch and Work Package for new projects.
• Monitor work in line with strategy, across internal departments and subcontractors, providing expert guidance to CMC subcontractors.
• Represent Pierre Fabre's CMC expertise to authorities; draft/check CMC parts of INDs/IMPDs/NDAs/MAAs.
• Define and manage the chemistry budget for all development phases.
• Support lifecycle management programs and regulatory changes for assets and raw materials.

Connaissances

CMC expertise

CDMO management

Project leadership

cGMP experience

English fluent

Chemical engineering

PhD in chemistry

Formation

Chemical Engineering degree

PhD in Chemistry

Description du poste

Pierre Fabre Laboratories in Toulouse (Oncopole) seeks a CMC Expert on a permanent contract to lead development and manufacturing strategies for new drug candidates. You will define CMC strategy, carry out module 3 quality reviews of product and project dossiers, sign QOS/variations, and oversee CDMO management and regulatory submissions.

You will ensure technical leadership across chemistry and development programs and monitor budgets.