Sanofi

Healthcare

HeadofGlobalCMC-VaccinesResearchandDevelopment

$345–498k Waltham, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Executive candidates.

The Brief

“Head of Global CMC - Vaccines Research and Development at Sanofi. Skills: CMC strategy, Vaccine development, Manufacturing processes, Regulatory compliance. Define and execute CMC strategy. Lead development of vaccine formulations”

Industry & Context.

Healthcare

What They're Looking For.

Must Have

PhD or MD/PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related, Extensive experience in vaccine or biopharmaceutical CMC, Extensive experience in formulation development, Extensive experience in manufacturing process development, Deep expertise in analytical chemistry, Deep expertise in quality control, Deep expertise in regulatory compliance (GMP, ICH guidelines, FDAA requirements), Proven track record of successfully developing and scaling vaccine or biopharmaceutical manufacturing processes from laboratory to commercial production, understanding of vaccine science, understanding of immunology, understanding of translational medicine

Nice to Have

MBA or executive business education is a asset, Experience with multiple vaccine platforms and modalities including mRNA, viral vectors, protein subunit, conjugates

What You'll Do.

Define and execute CMC strategy

Lead development of vaccine formulations

Lead development of manufacturing processes

Lead development of analytical methods

Establish analytical capabilities

Maintain analytical capabilities

Establish quality standards

Maintain quality standards

Manage technology transfer

Manage scale-up of vaccine manufacturing

Ensure regulatory compliance

Prepare CMC documentation

Drive continuous improvement initiatives

Partner with Clinical Development

Partner with Regulatory Affairs

Partner with Manufacturing

Partner with Supply Chain

Build strategic relationships with CMOs

Build strategic relationships with suppliers

Build strategic relationships with technology partners

Represent Sanofi in regulatory interactions

Represent Sanofi in industry forums

Represent Sanofi in scientific publications

Lead multidisciplinary CMC team

Develop multidisciplinary CMC team

Foster talent development

Foster organizational effectiveness

Establish CMC governance frameworks

Ensure alignment across programs

How You'll Work.

Team & Collaboration

Vaccines R&D Leadership Team; Clinical Development teams; Regulatory Affairs teams; Manufacturing teams; Supply Chain teams; Contract manufacturing organizations; Suppliers; Technology partners

Communication Scope

Scientific publications

Full Job Description

**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 commercia

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