Head of Global CMC - Vaccines Research and Development

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* Job title:

** Head of Global CMC - Vaccines Research and Development

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* Location:

** Waltham, MA

About the job

Are you ready to shape the future of medicine? The race is on to speed up vaccine development and bring life-saving vaccines to patients faster than ever before. Your skills could be critical in helping our teams accelerate progress. Join our Vaccines R&D Leadership Team at Marcy l'Etoile as Head of Global CMC and you'll define and execute our chemistry, manufacturing, and controls strategy, ensuring that cutting-edge vaccine discoveries are translated into safe, effective, and scalable products that reach patients around the world.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

In the context of the R&D evolution. our position is currently in Project Status, where the scope of this position may continue to evolve.

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

+ 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

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* What we do:

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* + 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

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* Who we are:

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* + 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

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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…