Shu-Chen Chen Genentech

I have over 30 years of diversified experience in process design, product development, project management, manufacturing, and quality assurance for the chemical, biomedical and biological industries. I joined Genentech in Sep 2017. My responsibilities include co-leading the PFS-NSD Technology Center, leading the collaboration with another biotech company to file and launch a new product for home use for the US market, and working with an outside vendor for an on-body injector project. Prior to Genentech, I worked at Amgen for almost 11 years and assumed the responsibility of developing various physical methods for Container Closure Integrity Testing and the roles of device engineer and device technical lead for several combination products. Prior to joining Amgen, I worked for Baxter Healthcare Corporation for 18 years, focusing on R&D Engineering in the areas of Infusion, hemodialysis and platelet apheresis at the beginning and then concentrating in Quality Engineering for product testing, product launch and regulatory compliance later.  I hold a Ph.D. degree in Chemical Engineering from Northwestern University, and am an ASQ Certified Quality Engineer, ASQ Certified Six Sigma Black Belt, and ASQ Certified Biomedical Auditor.