Head of Global CMC - Vaccines Research and Development

Job Title

Head of Global CMC - Vaccines Research and Development

Waltham, MA

Shape the future of medicine by accelerating vaccine development and delivering life‑saving vaccines faster than ever. In this leadership position, you will define and execute the chemistry, manufacturing, and controls (CMC) strategy to translate cutting‑edge discoveries into safe, effective, and scalable products for patients worldwide.

• Define and execute a comprehensive CMC strategy aligned with the Vaccines R&D portfolio 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 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, 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.

• 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 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.
• Full professional proficiency in French (essential for engagement at Marcy l’Êtoile).
• Professional fluency in English (C1/C2) essential for international regulatory interactions and global representation.

• Salary range: $ – $.
• Competitive health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.
• Hybrid work arrangements to support work‑life balance and a multicultural, international team environment.
• Opportunities for executive development, international mobility, and engagement with a world‑class ecosystem of academic, biotech, and global health partnerships.
• Access to Sanofi’s worldwide network and global R&D resources.

Sanofi and its affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or domestic partnership status, sex, gender identity or expression, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.