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

About the job

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.

Our Team

The Global CMC team is the bridge between vaccine discovery and manufacturing excellence. We are a diverse, international group of chemists, process engineers, analytical scientists, and manufacturing specialists united by a shared passion for developing robust, scalable, and compliant vaccine manufacturing processes that ensure quality and safety for patients worldwide.

Leadership & Structure

• You will report directly to the Head of Vaccines R&D (Jean‑François Toussaint)
• You will be a member of the Vaccines R&D Leadership Team (VRDLT), contributing to strategic decisions and portfolio priorities
• You will lead and develop the Global CMC team across multiple sites and disciplines

What we do

• Develop vaccine formulations and manufacturing processes from laboratory scale to commercial production
• Establish analytical methods, quality standards, and controls that ensure vaccine safety, purity, and potency
• Manage technology transfer and scale‑up of vaccine manufacturing across global production sites
• Ensure regulatory compliance and prepare comprehensive CMC documentation for regulatory submissions (FDA, EMA, etc.)
• Drive continuous improvement in manufacturing efficiency, cost, and sustainability
• Partner with Clinical Development, Regulatory Affairs, and Manufacturing teams to support vaccine development timelines
• Shape Sanofi’s long‑term CMC strategy and manufacturing capabilities for next‑generation vaccine platforms

Who we are

• A multicultural team of world‑class scientists and engineers based at Marcy l’Etoile, Europe’s leading vaccine R&D hub, with global connections
• Chemists, process engineers, and analytical scientists with deep expertise in vaccine formulation and manufacturing
• Regulatory and compliance specialists with experience in GMP and pharmaceutical development
• Strategic thinkers who bridge cutting‑edge science and manufacturing reality
• Collaborative leaders committed to cross‑functional alignment and operational excellence

Our culture

• We value scientific rigor combined with entrepreneurial thinking
• We communicate transparently and embrace calculated risk‑taking
• We celebrate diversity of thought as a source of innovation
• We are committed to work‑life balance and professional development

About Sanofi

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

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 organisations (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 organisational effectiveness
• Establish CMC governance frameworks and ensure alignment across global vaccine development programmes

Qualifications

• 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 contextualise 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 organisations
• 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

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future‑focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well‑crafted rewards package that recognises your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programmes

Compensation and Benefits

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programmes, and additional benefits information can be found here. Toute compensation sera déterminée en fonction de l’expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d’avantages sociaux de l’entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.

Equal Opportunity Employer

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, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.