Head of Global CMC - Vaccines Research and Development

Sanofi•Waltham, MA

1d•Hybrid

About The Position

The Head of Global CMC will define and execute the chemistry, manufacturing, and controls strategy for vaccine development, ensuring that discoveries are translated into safe, effective, and scalable products. This role is part of the Vaccines R&D Leadership Team and will lead and develop the Global CMC team across multiple sites and disciplines. The position is currently in Project Status, and its scope may evolve. The Global CMC team acts as a bridge between vaccine discovery and manufacturing excellence, comprising chemists, process engineers, analytical scientists, and manufacturing specialists focused on developing robust, scalable, and compliant vaccine manufacturing processes. The role involves developing vaccine formulations and manufacturing processes, establishing analytical methods and quality standards, managing technology transfer and scale-up, ensuring regulatory compliance, and driving continuous improvement in manufacturing efficiency and sustainability. The Head of Global CMC will partner with various teams to support development timelines and shape Sanofi's long-term CMC strategy.

Requirements

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
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

Nice To Haves

Experience in pandemic preparedness or rapid response vaccine manufacturing is highly valued

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