Selene Araya, Ph.D., ERT
Subject Matter Expert: Drug Substance/HPAPI
Selene Araya is a Managing Toxicologist in the Corporate EHS Department, Lonza AG since June 2018, working in the field of occupational toxicology and quality toxicology. She has a PhD in Pharmacology and Toxicology (University of Basel, CH), has been previously trained in occupational toxicology within Novartis (CH), holds a master degree in human biology (University of Zurich, CH) and she is a registered toxicologist (European Registered Toxicologist (ERT) as well as a Swiss Registered Toxicologist). Selene is part of the Corporate Toxicology team (CTx team) of Lonza with Lisa Wiesner, and there she is responsible for the compilation, review and approval of health hazard assessment monographs for drug substances, pharmaceutical intermediates, and extractable and leachables by providing health based exposure limits (HBELs) – which are permitted daily exposure (PDEs) and occupational exposure limits (OELs). She also supports non-conformances and product complaints assessments in the GMP environment by providing margin of safety calculations. Additionally, she likes to publish articles and present in congresses in the fields of occupational toxicology and patient safety aiming to apply scientific principles for the PDE and OEL determination (some recent topics of interest: applicability of PDE towards cleaning agents, OELs and sensitization, in silico mutagenicity).