Sanofi
Healthcare
HeadofGlobalCMCVaccinesResearchandDevelopment
“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.
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
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