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 Senior Director for 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 technologies in bioassay, analytical chemistry, microbiology, adventitious agent testing, risk-based/scientific-based control system, and strategic LM and SM stability approaches, being accountable for the product-analytical scientific expertise of the biological product portfolio, including CMC support. He participated at FDA, EMA, and global Health Authority meetings and has hands-on experience as a scientific content author of regulatory submission documents and approval of HA pre-approval inspections, e.g., EMA and RoW countries.

He has externally engaged as a presenter and panelist in multiple conferences and workshops sponsored by industry/regulatory. In addition, he is the BIO topic lead on the recently established informal ICH Q1s/Q5C Expert Working Group.