Joined Genentech’s nascent process development Analytical Chemistry group in 1984, initially with protein chemistry and molecular characterization responsibilities for development products such as hGH (Protropin), tPA (Activase), tissue factor, soluble CD4, Xolair and Herceptin. Identified many unexpected and/or novel protein modifications, which led to the good-natured “Dr. Doom” honorific awarded by project team colleagues.
Global Xolair Genentech/Novartis CMC team leader from Phase II through the initial licensing stage, and leader of the team that brought in BR3-Fc from Biogen. Head of US Biologics Pharma Technical Development analytical development and QC functions from 2004 to 2014, during which strategies were developed for comparability assessments, clinical specifications, critical quality attribute identification and commercial control strategies. Co-sponsor of Genentech’s PTD Innovation Team. Ad interim head of Roche’s global PTD-Quality function from 2014 to 2015.
Author of 48 publications, including 20 as corresponding author. Topics include recombinant protein characterization methods, the identification of novel or unexpected protein structures, covalent modifications and sequence variants, and reviews of techniques for identifying critical quality attributes. Currently a Senior Staff Scientist in Pharma Technical Development, based in South San Francisco.