Boris Zimmermann

Boris Zimmermann holds a Ph.D. in Physical Chemistry from the University of Freiburg, Germany. After finishing his postdoctoral research, he spent over 15 years in the pharmaceutical industry at Roche/Genentech. Boris currently serves as Head of Analytical Sciences, with strategic responsibility for control system lifecycle management and LM and SM stability program management from development, characterization, and commercial lot release to stability testing. He is the advisor and champion for new QC/Analytical technologies in bioassay, analytical chemistry, microbiology, adventitious agent testing, risk-based/scientific-based control systems, and new LM and SM stability approaches, being accountable for the product-analytical scientific expertise of the biological product portfolio, including respective CMC support. He routinely meets with global Health Authorities and has hands-on experience in QC operational execution and as a scientific content author of regulatory submission documents and pre-approval inspections. He has externally engaged as a presenter and panelist in multiple conferences and workshops sponsored by industry/regulatory. In addition, he is a member of the ICH Q1s/5C Expert Working Group, which is currently revising the ICH quality stability guideline.