CMC Expert – Remote-Ready Pharma Development Lead

Pierre Fabre Laboratories; Occitanie; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Teleworking up to 2 days/week

Résumé du poste

Pierre Fabre Laboratories seeks a Chemical Engineer or PhD in chemistry to lead CMC strategy across development programs in Toulouse (Oncopole). Fluent English and extensive cGMP expertise are essential as you collaborate with cross-functional teams and external CDMOs.

You will manage CMC work packages, prepare regulatory submissions (INDs/IMPDs/NDAs/MAAs), and mentor teams while controlling budgets and timelines in a fast-growing, innovative environment.

Qualifications

• Chemical engineer or PhD in chemistry.
• Minimum 10 years’ experience in CMC expertise acquired through several clinical studies (phase 1 to phase 3), ideally up to registration.
• Fluent English essential.
• Extensive experience in Good Manufacturing Practices (cGMP).
• 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 its CMC expertise and ensure that it is transcribed into dossiers as a CMC expert.
• You 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, as well as technological and CMC watch.
• You will be responsible for monitoring work in line with this strategy, in terms of quality/cost/timeframe.
• Represent Pierre Fabre’s CMC expertise to the authorities in case of questions. You draft and/or check the CMC parts of INDs/IMPDs/NDAs/MAAs.
• Define and manage the chemistry budget for all development phases.

Connaissances

Fluent English

cGMP

CDMO management

Project management

CMC expertise

Analytical chemistry

Formation

Chemical engineer or PhD in chemistry

Description du poste

Pierre Fabre Laboratories seeks a Chemical Engineer or PhD in chemistry to lead CMC strategy across development programs in Toulouse (Oncopole). Fluent English and extensive cGMP expertise are essential as you collaborate with cross-functional teams and external CDMOs.

You will manage CMC work packages, prepare regulatory submissions (INDs/IMPDs/NDAs/MAAs), and mentor teams while controlling budgets and timelines in a fast-growing, innovative environment.