CMC Project Manager- M/F (CDD)

Pierre Fabre Laboratories; Toulouse; Hybride; EUR 70 000 - 100 000; Temps partiel

Avantages offerts par ce poste

Profit sharing

Health insurance

Public transport support

Résumé du poste

Pierre Fabre Laboratories is seeking a Projet Manager for CMC (CMC-PM) on a 12-month contract at our Toulouse site. You will support the CMC expert team across clinical development from phase 1 to registration, coordinating timelines, meetings, and documentation with partners.

The role offers hybrid work up to 2 days remote per week and a comprehensive benefits package. Ideal candidates hold an MSc or engineering degree in pharmaceutical sciences with at least 5 years' CMC development

Qualifications

• MSc or Engineer in pharmaceutical science and ideally Pharma-related degree.
• Minimum 5 years' experience in planning pharmaceutical development for CMC across phases 1–3, up to registration.
• Strong knowledge of Good Manufacturing Practices (cGMP).
• Experience leading or coordinating with a CDMO/partner in development programs.
• Proven ability to manage programs, budgets, and governance communications.

Responsabilités

• Coordinate CMC subteam activities with respect to timelines.
• Organize internal CMC team meetings and meetings with partners.
• Support CMC subteam planning and budget management.
• Assist CMC Subteam Leader and Governance meeting prep/slide coordination.
• Coordinate preparation and updates of CMC documentation for clinical submissions (IND/IMPD sections, amendments).
• Coordinate and present updates for Module 3 planning ahead of Phase 3/registration.
• Serve as the point of contact for transversal CMC topics within P&O.

Connaissances

CMC coordination

Project management

Budget management

Leadership

Cross-functional collaboration

GxP/cGMP

Formation

MSc or Engineer in pharmaceutical science

Outils

PowerPoint

Description du poste

We are recruiting a Projet Manager for CMC (CMC-PM) on a short-term contract (12 months) for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Medical Care's R&D Department.

You will be responsible for supporting the CMC expert team for the clinical projects with Pierre Fabre as lead CMC.

This includes the coordination all along the pharmaceutical development from phase 1 to registration of new biological or chemical drug candidates, and transversal subjects assigned to this team.

Your role within a pioneering company in full expansion:

More specifically, you will:

• Coordinate CMC subteam activities with respect of timelines
• Be responsible for internal CMC team meetings organization and with partners
• Support CMC subteam in the planification of the CMC activities and for budget management
• Support CMC Subteam Leader (Pharma Strategic Leader or PSL) in his tasks
• Support Governance meetings preparation/coordination of slides-deck completion for CMC
• Coordinate preparation and update of CMC documentation for clinical submissions, such as:
  • IND / IMPD initial CMC sections
  • Amendments and updates for formulation/process changes, scale-up, site changes
  • Module 3 draft planning ahead of Phase 3 / registration
• Be the point of contact for expert team transversal subjects as CMC-PM

(Focal point of P&O department (Outsourcing Manager, Planner, Portfolio manager)

You will report to the Head of Pharmaceutical development on this role.

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation...

Your skills at the service of innovative projects:

MSc or Engineer in pharmaceutical science (chemistry, biologic, formulation or analytics)

Minimum 5 years' experience in conducting pharmaceutical development plan for CMC acquired through several clinical studies (phase 1 to phase 3), ideally up to registration.

Extensive experience in Good Manufacturing Practices (cGMP)

You have already managed a CDMO or Partner

Experience of technical leadership in project management associated with development programs is required.