Head of Global CMC - Vaccines Research and Development

Job title: Head of Global CMC - Vaccines Research and Development

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

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

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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 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

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 recognizes 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 programs and at least 14 weeks' gender-neutral parental leave

• Lead one of the industry's most ambitious external innovation agendas, shaping the future of Sanofi's global vaccine pipeline

• Build and influence a world-class ecosystem of academic, biotech, and global health partnerships at the forefront of pandemic preparedness

• Work from Marcy l'Etoile, Europe's leading R&D hub for vaccine innovation, with true global impact and access to Sanofi's worldwide network

• Benefit from flexible hybrid work arrangements supporting work-life balance while being part of a multicultural, international team

• Access to executive development programs and international mobility opportunities within Sanofi's global R&D organization

Learn more about Sanofi

• Sanofi Vaccines Division

• Sanofi Diversity, Equity & Inclusion

• Watch "One day at Sanofi"

Pursue progress, discover extraordinary

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.