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Director, CMC – Biologics Development
Permanent – Southern France or Remote
Our client, an innovative biotechnology company specializing in immuno-oncology, is seeking a Director, CMC & Pharmaceutical Operations.
You will join a well-established, publicly listed biotech company with a strong pipeline spanning early-stage research through advanced clinical development.
As Director, CMC & Pharmaceutical Operations, you will provide strategic leadership for CMC activities across the biologics lifecycle, overseeing pharmaceutical operations, CDMOs and clinical supply to support global development programmes.
For highly experienced EU-based candidates, a remote setup is possible, with regular travel to the company’s head office in Marseille. In this case, you’d be employed under a contract aligned with your country of residence—for example, a German employment contract if based in Germany.
RESPONSIBILITIES
Reporting directly to the COO/CSO within the Research & Early Development division, you will define and lead the CMC and Supply Chain strategy across the company’s development portfolio.
Your key responsibilities will include:
- Define and drive development program strategies, ensuring CMC and Supply Chain activities remain aligned with the company’s scientific, clinical, regulatory and business objectives.
- Lead pharmaceutical development activities across the biologics lifecycle, from cell line development through finished product manufacturing, and define development, control and manufacturing strategies to support late-stage clinical development and future marketing authorization.
- Oversee preparation of the CMC sections of global regulatory submissions and contribute to interactions with health authorities.
- Select, negotiate and manage international CDMO and external manufacturing partners.
- Oversee GMP manufacturing activities, technology transfers and outsourced pharmaceutical operations.
- Lead the clinical supply chain to ensure uninterrupted product availability for international clinical trials.
- Manage and develop the Pharmaceutical Operations team while presenting strategic priorities, budgets and investment plans to the Executive Leadership Team.
YOUR PROFILE
- Advanced scientific degree in Pharmacy, Biotechnology, Chemical Engineering, Process Engineering or a related discipline.
- Extensive CMC leadership experience in biologics within the pharmaceutical or biotechnology industry.
- Broad CMC expertise across biologics development, including late-stage clinical development, with a strong understanding of global regulatory requirements.
- Proven experience managing CDMOs and outsourced GMP manufacturing activities.
- Demonstrated people management experience.
- Ability to combine strategic vision with hands-on execution and operational leadership.
- Fluent professional English is essential. French an advantage.
BENEFITS
- Competitive compensation package.
- Flexible remote work policy.
Confidentiality assured: Your CV will not be submitted to our client without your prior consent following an initial discussion with us. Please feel free to contact us in complete confidence if you’d like to find out more about this opportunity.
Poste à pourvoir, Ref. : PR-0348EN