Head of Global CMC Research and Development - Vaccine

Reference no. R2861649

Position title:

Head of Global CMC Research and Development - Vaccinet Department:
Vaccines Research & Development

Location:

Toronto, ON

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale — and shape the future of immunization. The race is on to speed up vaccine development and bring life-saving vaccines to patients faster than ever before.

• 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.

• 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.
• English: professional fluency (C1/C2) essential for international regulatory interactions and global representation.

Sanofi is an equal opportunity employer committed to diversity and inclusion.

Our goal is to attract, develop and retain highly talented employees from diverse backgrounds. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.