Karen Z. McCullough, MS MMI Associates

Karen Zink McCullough is the Principal Consultant at MMI Associates, LLC. She has a degree in Microbiology from Rutgers University and a Masters degree in Molecular Biology from the University of Oregon. Karen has been involved in endotoxin testing for 40+ years, and is an expert in the field, having published and spoken widely on the subject of bacterial endotoxins. She has held numerous leadership and executive level positions in pharmaceutical manufacturing, cell and gene therapy manufacturing and CDMOs and has been a key participant in a number of cell and gene start-ups, focusing on Quality Systems, Quality by Design, Facilities and Validation. She has been a member of the United States Pharmacopeia Expert Committee, Microbiology General Chapters since 2010.