Erik Fouts is the Vice President and Site Head for BioMarin’s California based manufacturing facilities. He is responsible for the production and technical support functions associated with the manufacture of four marketed biologics products and several clinical candidates. The role requires the management of staff in four commercial and clinical manufacturing facilities located in Novato, California. Erik joined BioMarin as a member of the Protein Purification Process Development group in 2000, and since then has taken on positions of increasing responsibility within Technical Operations. Erik was performing gene expression research at Lawrence Berkeley National Laboratory prior to coming to BioMarin and holds a Ph.D. in Molecular and Cell Biology from U.C. Berkeley. During his tenure as head of Process Sciences at BioMarin, Erik was responsible for the development, CMC section authoring/review, and technical support of three commercial recombinant enzyme processed that utilize continuous perfusion cell culture technology. As the head of the Novato manufacturing site, Erik is now responsible for the ongoing lifecycle management of these continuous manufacturing processes. He is currently representing BIO as an expert to the ICH Q13 Expert Working Group for developing a guideline for continuous manufacturing.