Head of Global CMC - Vaccines Research and Development
$345,000–$498,333 year
Hybrid · Waltham, Massachusetts, United States or Swiftwater, Pennsylvania, United States
Job Summary
Lead the Global CMC function for Sanofi Vaccines R&D, defining and executing a comprehensive CMC strategy across multiple vaccine platforms; develop vaccine formulations, manufacturing processes, and analytical methods; ensure GMP compliance, prepare CMC documentation for regulatory submissions (FDA, EMA, WHO); manage technology transfer and scale-up across global sites; drive cost reduction, quality and sustainability while maintaining safety and efficacy; build and lead a high-performing, multidisciplinary team and establish governance frameworks; collaborate with Clinical Development, Regulatory Affairs, Manufacturing, and Supply Chain; engage with CMOs and regulatory authorities. Requires PhD or MD/PhD in related field; deep expertise in CMC, formulation development, regulatory compliance; senior leadership experience; proficiency in French (full professional) and English (C1/C2).
Required Qualifications
- PhD or MD/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; MBA or executive business education is a strong asset
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