Project Manager (bRo5 molecules)

Barrington James; Marseille; Sur place; EUR 75 000 - 95 000; Plein temps

Résumé du poste

A leading pharmaceutical company in Marseille is seeking a Project Manager to oversee development programs for complex bRo5 molecules. This role will manage project timelines, budgets, and risks while ensuring effective communication across multiple departments. The successful candidate will have strong experience in CMC project management, particularly with non-traditional small molecules. A master's or PhD in a relevant field is required, along with a solid understanding of regulatory CMC requirements. This is an exciting opportunity to lead critical projects in a dynamic environment.

Qualifications

• 5–10+ years of experience in CMC project management or technical development.
• Strong understanding of challenges related to solubility, permeability, and bioavailability.
• Solid knowledge of cGMP, ICH guidelines, and regulatory CMC requirements.

Responsabilités

• Lead end‑to‑end CMC project management for bRo5 molecules.
• Drive integrated project plans across various departments.
• Act as the primary interface with external CDMOs and CROs.

Connaissances

CMC project management

Cross-functional leadership

Stakeholder management

Risk management

Technical oversight

Formation

MSc or PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering

Outils

DoE

Description du poste

We are seeking a Project Manager to join our team who specializes in Beyond Rule of 5 (bRo5) molecules and can lead cross‑functional CMC development programs for complex, non‑traditional small molecules.

This role is central to coordinating technical strategy, timelines, and execution across discovery, development, and manufacturing for challenging chemical entities with unique solubility, permeability, and bioavailability profiles.

The successful candidate will act as the integration point between chemistry, formulation, process development, analytical, regulatory, and external partners, ensuring technically sound and executable development plans.

Key Responsibilities

CMC & bRo5 Program Leadership

• Lead end‑to‑end CMC project management for bRo5 molecules, including macrocycles, peptides, and other complex chemotypes.
• Coordinate development strategies addressing solubility, permeability, stability, and exposure challenges typical of bRo5 compounds.
• Ensure alignment between discovery, preclinical, and clinical development activities.

Cross‑Functional Project Management

• Drive integrated project plans across Process Development, Formulation, Analytical Development, Regulatory CMC, Quality, and Supply Chain.
• Own timelines, milestones, budgets, and risk registers for assigned programs.
• Chair regular cross‑functional meetings and ensure clear decision‑making and accountability.

Technical Oversight & Risk Management

• Partner with scientific teams to identify and mitigate CMC and manufacturing risks associated with bRo5 molecules.
• Track and coordinate risk‑based development strategies, including enabling formulations and early manufacturability assessments.
• Ensure appropriate application of DoE, modeling, and platform technologies where relevant.

External Partner & CDMO Management

• Act as the primary interface with external CDMOs, CROs, and formulation partners supporting bRo5 programs.
• Oversee tech transfer activities, development campaigns, and GMP manufacturing readiness.
• Coordinate issue resolution related to deviations, changes, and supply risks.

Regulatory & Governance Support

• Coordinate inputs for CMC regulatory submissions (IND/IMPD/CTA, NDA/MAA), ensuring consistency and technical accuracy.
• Support responses to health authority questions related to complex molecule development.
• Prepare materials for internal governance and portfolio review meetings.

Required Qualifications

• MSc or PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 5–10+ years of experience in CMC project management or technical development, with direct exposure to bRo5 molecules.
• Strong understanding of non‑traditional small molecules, including challenges related to solubility, permeability, and bioavailability.
• Demonstrated ability to manage complex, cross‑functional development programs in biotech, pharma, or CDMO environments.
• Solid knowledge of cGMP, ICH guidelines, and regulatory CMC requirements.
• Excellent communication and stakeholder management skills.