Joe Galati, PhD, is Senior Director, Global Toxicology Services at Thermo Fisher Scientific, and has more than 20 years of experience in the pharmaceutical industry, specializing in product quality and occupational toxicology.

Dr. Galati has expertise in the toxicological evaluation of active pharmaceutical ingredients, intermediates, contaminants, and extractables and leachables. He is responsible for assigning appropriate toxicity categorizations and occupational exposure bands (OEBs), establishing occupational exposure limits (OELs) to ensure worker safety, and deriving health-based exposure limits (HBELs), threshold of toxicological concern (TTC), permitted daily exposure (PDE), and acceptable daily exposure (ADE) values to support patient safety.

His experience also includes collaboration with Environment, Health, and Safety (EHS) professionals on handling, containment, and medical surveillance strategies, as well as with Quality and Regulatory Affairs professionals to ensure compliance with Good Manufacturing Practice (GMP) requirements in multi-product facilities. He provides scientific and regulatory guidance on potential product quality and safety considerations, including those related to cytotoxic, cytostatic, hormonal, sensitizing, and beta-lactam containing compounds.

Dr. Galati obtained his Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto and is a Full Member of the U.S. Society of Toxicology and the Society of Toxicology of Canada. He is the author of several peer-reviewed publications and has presented at numerous international scientific meetings and academic institutions across North America and Europe.