Karen Zink McCullough is the Managing Member of MMI Associates, LLC, specializing in pharmaceutical quality systems and microbiology, with a focus on endotoxins and pyrogens testing.

Ms. McCullough has held a number of executive positions in the pharmaceutical and medical device industries including Vice President of Quality Operations (cell manufacturing), Vice President of Quality Operations (cell/gene CDMO), Sr. Director Quality Compliance (diagnostics) and Director, Microbiology (SVP).Ms. McCullough has held a number of executive positions in the pharmaceutical and medical device industries including Vice President of Quality Operations (cell manufacturing), Vice President of Quality Operations (cell/gene CDMO), Sr. Director Quality Compliance (diagnostics) and Director, Microbiology (SVP).

She is a highly respected nationally and internationally recognized GMP speaker and trainer, with corporate and local presentations/seminars/courses on Bacterial Endotoxin Detection, QC Microbiology, Quality Systems in Cell and Gene Manufacturing, Auditing and Risk. She has edited two books, one entitled “The Bacterial Endotoxins Test: A Practical Guide” and has authored 34 publications and 29 book chapters on BET, Microbiology, and Quality S stems. She was a founding member of the LAL Users’ Group and has served on several task forces and committees working with PDA and ISO on topics related to pharmaceutical microbiology.

Ms. McCullough holds a Bachelor’s degree in Bacteriology from Rutgers University and a Masters degree in Molecular Biology from the University of Oregon.