Greg SearsGlobal Director of Process Validation, Manufacturing Sciences and Technology at Patheon, part of ThermoFisher Scientific
Mr. Sears is currently Global Director of Process Validation for ThermoFisher Scientific’s Biologics division. Additionally, he is the Head of Manufacturing Science and Technology at the St. Louis manufacturing plant for ThermoFisher. He has been devoted to biologics manufacturing for twenty-three (23) years, has written multiple industry articles related to process validation applicable to both single use technologies and standard processing techniques; Mr. Sears was an industry contributor to the current revision of EMA Annex 15, and has been a contributor in BPOG’s working group related to data capture and data trending when applying new information technologies to legacy products. Mr. Sears has validated approximately thirty-five biologics processes since 2007, successfully navigating the industry changeover from previous regulatory guidance to current practices along the way. This extensive experience has led to a high degree of interaction with regulatory bodies as well, presenting to FDA on application of the 2011 guidance’s to multi-train production facilities, and how to embody risk- and science-based approaches into the process validation effort for a biologics product. The movement toward strong scientifically- and risk-based understanding has led to a further shift in approaches to process validation at the close of the first 20 years of the century, and Mr. Sears’s background in statistics has played a key role in shaping strategy in the high-cost, low-run count arena for process validation.