Back to WiM New York Chapter Affiliated Members
Analytical CMC Leader - Vaccine
Contact information may be available to logged in members.
Elena Smith, PhD, is Analytical CMC leader at Sanofi Vaccines and lead the definition and implementation of analytical strategy for vaccines in mRNA platform. Dr Smith joined Sanofi (Protein Sciences) in 2013 and led Quality Control for the commercialization of the new product, world's first recombinant Influenza vaccine Flublok, with several seasons of product scale-up on the market. Elena contributed to analytical strategy, provided CMC IND/BLA and analytical transfer support for various products produced in the recombinant platform products spanning from Phase 1 to Commercial including bringing to the market Flublok Quadrivalent/Supemtek. In her following role in the Sanofi as Quality Analytical Expert, Elena provided her expertise by leading technical CMC discussions with Regulatory authorities and being site Quality lead for product launches of Flublok Quadrivalent/Supemtek in several countries as well as being part of CMC team for the brining to the market new COVID 19 vaccine booster - VidPrevtin. Dr. Smith obtained her Ph.D. in Molecular Biology on HIV antivirals following completion of postdoctoral training on Molecular Pharmacology at U.S. National Institutes of Health. Dr. Smith focuses her industrial operations interests on quality strategy for new products, standards, tech transfer, manufacturing process, and microbiological control of manufacturing sites. Dr Smith is a lead of subgroup for early availability of reagents at WHO Pandemic SWITCH Potency Assay Working Group contributing to WHO operation plan for Pandemic Influenza Vaccine Response.
Connecticut, Massachusetts, New York
Continuous Improvement, Quality Control, R&D