Head of Global CMC - Vaccines R&D

Job Title: Head of Global CMC, Vaccines R&D

Location: Marcy l'Etoile, France / Waltham, MA

Grade: LE

Hiring Manager: Jean-Francois Toussaint

Work Format: Hybrid

About the job

In the context of the R&D evolution, the Head of Global CMC will shape the future of vaccine development by defining and executing the chemistry, manufacturing, and controls (CMC) strategy. The role ensures that cutting‑edge vaccine discoveries are translated into safe, effective, and scalable products that reach patients worldwide.

Main Responsibilities

• Define and execute a comprehensive CMC strategy aligned with the Vaccines R&D portfolio, manufacturing capabilities, and regulatory requirements.
• Lead the development of vaccine formulations, manufacturing processes, and analytical methods across multiple platforms (mRNA, viral vectors, protein subunit, conjugates, etc.).
• Establish and maintain state‑of‑the‑art analytical capabilities, quality standards, and controls to ensure vaccine safety, efficacy, and consistency.
• Manage technology transfer and scale‑up of vaccine manufacturing from laboratory to commercial production across global sites.
• Ensure full regulatory compliance with GMP standards and prepare comprehensive CMC documentation for regulatory submissions (FDA, EMA, WHO, and other authorities).
• Drive continuous improvement initiatives in manufacturing efficiency, cost reduction, and sustainability while maintaining quality standards.
• Partner closely with Clinical Development, Regulatory Affairs, Manufacturing, and Supply Chain teams to support vaccine development timelines and commercial launch.
• Build and maintain strategic relationships with contract manufacturing organizations (CMOs), suppliers, and technology partners.
• Represent Sanofi Vaccines R&D in regulatory interactions, industry forums, and scientific publications related to vaccine manufacturing and quality.
• Lead and develop a high‑performing, multidisciplinary CMC team, fostering talent development and organizational effectiveness.
• Establish CMC governance frameworks and ensure alignment across global vaccine development programs.

About You

• PhD or MD/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; MBA or executive business education is a strong asset.
• Extensive experience in vaccine or biopharmaceutical CMC, formulation development, or manufacturing process development.
• Deep expertise in analytical chemistry, quality control, and regulatory compliance (GMP, ICH guidelines, FDA/EMA requirements).
• Proven track record of successfully developing and scaling vaccine or biopharmaceutical manufacturing processes from laboratory to commercial production.
• Strong understanding of vaccine science, immunology, and translational medicine to contextualize CMC decisions.
• Experience with multiple vaccine platforms and modalities including mRNA, viral vectors, protein subunit, and adjuvant technologies.
• Senior leadership experience managing large, multidisciplinary CMC teams in matrixed global organizations.
• Proven ability to manage complex regulatory interactions and prepare comprehensive CMC documentation for regulatory submissions.
• Experience establishing quality standards, analytical methods, and controls for biopharmaceutical products.
• Strong network within the vaccine manufacturing and regulatory community, including CMOs, regulatory agencies, and industry consortia.
• Strategic and entrepreneurial leader with deep scientific curiosity, exceptional communication skills, and executive presence.
• Experience in pandemic preparedness or rapid response vaccine manufacturing is highly valued.
• French: full professional proficiency required. English: professional fluency (C1/C2) essential.

Benefits

• Thoughtfully crafted rewards package that recognizes your contribution and amplifies your impact.• Wide range of health and wellbeing benefits including high-quality healthcare and prevention and wellness programs.• At least 14 weeks of gender‑neutral parental leave.• Flexible hybrid work arrangements supporting work‑life balance.• Executive development programs and international mobility opportunities within Sanofi’s global R&D organization.

Compensation

Salary range: € – € . Final compensation will be determined based on experience, skills, location, and other relevant factors.

Equal Opportunity Employer

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.