Dr. McDonough is responsible for developing new nerve agent, chlorine, and cyanide antidotes and stabilizing autoinjectable nano-suspension formulations for the U.S. Departments of Defense and Health & Human Services. This involves working under current Good Manufacturing Practice (cGMP) guidelines, managing electronic filings with the Food and Drug Administration, and overseeing animal model and clinical studies. Additionally, he has developed novel calcium phosphate nanoparticle systems for small drug, interfering ribonucleic acid (iRNA), and large protein delivery. He oversees programs in ocular transdermal, oral, and autoinjectable intramuscular delivery, primarily focusing on micro- and nanoparticle formulations of new and existing pharmaceuticals to render them deliverable by alternative routes of administration and for different indications. He performs work under Good Laboratory Practices (GLP), Drug Enforcement Administration (DEA) controlled drug substances, and ISO 13485 medical device guidelines. He has 24 years of experience managing research efforts in pharmaceutical development including bulk and dosage-form manufacturing, regulatory strategy and compliance for filings, and licensing of new chemical entities.

Dr. McDonough led chemistry, manufacturing, and controls (CMC) development efforts for a chiral developmental diabetes compound while at Metabolex. This involved identifying and developing resolution technology to provide one enantiomer of the lead compound and was complicated by optical instability and polymorphism that the compound exhibited. He solved these problems in parallel with execution of the dosage form development, analytical and bioanalytical methods development, active and dosage form manufacture, investigational new drug (IND) filing, and implementation of a stability program.

At ILEX Oncology, Dr. McDonough was responsible for establishing a contract drug development service to cover method development and validation, formulation, quality control, synthesis and process development, and cGMP manufacturing. He wrote standard operating procedures (SOPs) and setup the cleaning, and installation and operational qualification programs. He established a stability program and a finished dosage development and manufacturing service, and transitioned from an academic drug development company to an aggressive contract research organization. He was directly involved with the filing of seven IND applications and multiple IND updates. These INDs included cytotoxic oncolytics, antivirals, and chemoprevention agents; updates included dosage form, analytical, and process changes.

At Hoechst Celanese Corporation, Bulk Analgesics & Acylation Chemicals Division, Dr. McDonough was head of a team with global membership to develop a novel technology for production of specialized nonionic surfactants. He also developed commercial chemical processes for advanced intermediates from a 4-hydroxyacetophenone platform. In the Bulk Pharmaceuticals and Intermediates Section, he led a team that transferred technology and troubleshot the implementation of a new process for Coumadin, an anticlotting agent. He also led teams for production of Pemoline, an attention-deficit hyperactivity disorder drug, and Clonazepam, an antiepileptic drug.

Dr. McDonough is a member of the editorial board for Military Medical Science Letters, a national professional journal for military doctors, published through the Faculty of Military Health Sciences, University of Defence.