Head of Global CMC - Vaccines Research and Development
Sanofi
July 01, 2026
Remote friendly (Waltham, MA)
United States
$345,000 - $498,333.33 USD yearly
Operations
Main Responsibilities
- Define and execute a comprehensive CMC strategy aligned with Vaccines R&D portfolio priorities, manufacturing capabilities, and regulatory requirements.
- Lead development of vaccine formulations, manufacturing processes, and analytical methods across multiple platforms (mRNA, viral vectors, protein subunit, conjugates, etc.).
- Establish and maintain analytical capabilities, quality standards, and controls to ensure safety, efficacy, and consistency.
- Manage technology transfer and scale-up from laboratory to commercial production across global sites.
- Ensure GMP regulatory compliance and prepare comprehensive CMC documentation for submissions (FDA, EMA, WHO, and other authorities).
- Drive continuous improvement in manufacturing efficiency, cost reduction, and sustainability while maintaining quality.
- Partner with Clinical Development, Regulatory Affairs, Manufacturing, and Supply Chain to support development timelines and commercial launch.
- Build/maintain relationships with CMOs, suppliers, and technology partners.
- Represent Vaccines R&D in regulatory interactions, industry forums, and scientific publications.
- Lead and develop a high-performing multidisciplinary CMC team; establish CMC governance frameworks and alignment across programs.
Qualifications
- PhD or MD/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; MBA/executive business education is a strong asset.
- Extensive vaccine/biopharmaceutical CMC, formulation development, or process development experience.
- Deep expertise in analytical chemistry, quality control, and regulatory compliance (GMP, ICH, FDA/EMA).
- Proven track record scaling manufacturing from lab to commercial production.
- Strong vaccine science/immunology/translational medicine understanding.
- Experience across multiple vaccine modalities (mRNA, viral vectors, protein subunit, adjuvants).
- Senior leadership experience managing large multidisciplinary global teams.
- Strong French (full professional proficiency) and English (C1/C2) proficiency.
- Pandemic preparedness or rapid response vaccine manufacturing experience highly valued.
Benefits (as stated)
- At least 14 weeks’ gender-neutral parental leave and health/wellbeing benefits.
Application instructions
- Not specified.
- Define and execute a comprehensive CMC strategy aligned with Vaccines R&D portfolio priorities, manufacturing capabilities, and regulatory requirements.
- Lead development of vaccine formulations, manufacturing processes, and analytical methods across multiple platforms (mRNA, viral vectors, protein subunit, conjugates, etc.).
- Establish and maintain analytical capabilities, quality standards, and controls to ensure safety, efficacy, and consistency.
- Manage technology transfer and scale-up from laboratory to commercial production across global sites.
- Ensure GMP regulatory compliance and prepare comprehensive CMC documentation for submissions (FDA, EMA, WHO, and other authorities).
- Drive continuous improvement in manufacturing efficiency, cost reduction, and sustainability while maintaining quality.
- Partner with Clinical Development, Regulatory Affairs, Manufacturing, and Supply Chain to support development timelines and commercial launch.
- Build/maintain relationships with CMOs, suppliers, and technology partners.
- Represent Vaccines R&D in regulatory interactions, industry forums, and scientific publications.
- Lead and develop a high-performing multidisciplinary CMC team; establish CMC governance frameworks and alignment across programs.
Qualifications
- PhD or MD/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; MBA/executive business education is a strong asset.
- Extensive vaccine/biopharmaceutical CMC, formulation development, or process development experience.
- Deep expertise in analytical chemistry, quality control, and regulatory compliance (GMP, ICH, FDA/EMA).
- Proven track record scaling manufacturing from lab to commercial production.
- Strong vaccine science/immunology/translational medicine understanding.
- Experience across multiple vaccine modalities (mRNA, viral vectors, protein subunit, adjuvants).
- Senior leadership experience managing large multidisciplinary global teams.
- Strong French (full professional proficiency) and English (C1/C2) proficiency.
- Pandemic preparedness or rapid response vaccine manufacturing experience highly valued.
Benefits (as stated)
- At least 14 weeks’ gender-neutral parental leave and health/wellbeing benefits.
Application instructions
- Not specified.