Head of Global CMC - Vaccines Research and Development

Main responsibilities

• Define and execute a comprehensive CMC strategy aligned with Vaccines R&D portfolio priorities, manufacturing capabilities, and regulatory requirements
• Lead the development of vaccine formulations, manufacturing processes, and analytical methods across multiple vaccine 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 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 (essential for working at Marcy l'Etoile and engaging with French stakeholders)
• English: professional fluency (C1/C2) essential for international regulatory interactions and global representation