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Timothy McCoy
Head Formulation & Process Development at Sanofi

Profile

Tim leads the Global Lyophilization Center of Excellence at Sanofi R&D, where he leads Lyo strategy for development and commercialization of lyo products and technology. In addition, Tim holds the position of  Unit Head Formulation & Process Development, leading Drug Product Development programs from first in human to commercialization & launch. In both roles, Tim leads a team of scientists in execution of development studies associated with these strategic and CMC program goals. Tim’s individual responsibility also includes CMC Drug Product leadership from first in human through to commercialization and launch, responsible for the technical delivery of the program including technology transfer to the industrial site. Tim has approximately 17 years’ experience in fill finish manufacturing science and specializes freeze drying, spanning from development & scale up, through to manufacturing.
Tim joined Sanofi R&D in March 2018, having being with Sanofi industrial Affairs (IA) for 5.5 years. While in IA, Tim led a Drug Product Manufacturing Sciences team, with expertise in bioinjectables and specifically, Lyophilization development and scale up. Tim previously held positions at Wyeth (Pfizer) Biotech, Ireland and Boehringer Ingelheim, USA. In his career to date, Tim has worked with small molecules, vaccines and proteins in both aqueous and co solvent systems.

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