Beth Junker is currently Senior Scientific Director in the Biologics Pre-Clinical Development group at Merck. She has twenty-one years experience in the pharmaceutical industry in process development for natural products, therapeutic proteins, and vaccines. Previously she was responsible for non-GMP laboratory and pilot scale bioprocess operation areas, as well as rapid production of reagent proteins. Currently, she is responsible for QbD, knowledge management, operational excellence, as well as safety and environmental compliance, in the bioprocess area. She has completed her Six Sigma black belt certification and is working towards her master black belt certification. She recently led the design of an initial bioprocess QbD strategy within the company and now is working on its implementation. Within ISPE PQLI she is a member of the newly formed Biotech Task Team. She received her Bachelor of Science in chemical engineering from Princeton University and PhD in chemical engineering from the Massachusetts Institute of Technology.