Duane L. Mauzey, MS, D-ABC, DRSc, RAC
Adjunct Assistant ProfessorRegulatory and Quality Sciences
- Halozyme Therapeutics, San Diego, CA
MS, Criminalistics, California State University, Los Angeles
DRSc, Regulatory Science, USC School of Pharmacy
Duane began his career in the 1970’s as a criminalist (CSI) with the California Department of Justice Bureau of Forensic Services, where he helped to put five murderers in prison for life without parole. He left the crime lab in 1985 and worked in sales as a representative for several major laboratory instrument manufacturers, including Perkin-Elmer and Waters. From there, Duane accepted a position as a scientist in a new R&D facility at McGaw, now B. Braun, where he specialized in training, analytical instrument qualification, software validation, and generic nasal spray product development. Duane migrated to Allergan in 2001, moving into Pharmaceutical Analysis where he performed a large variety of tasks associated with the chemistry and controls of drug substances and products. He retired from Allergan in the Spring of 2015 after eight years as the manager of CMC Scientific Affairs for Allergan, where he was responsible for managing the assembly, review, and QC of the Quality/CMC sections for global regulatory submissions. Duane moved on to become the Senior Manager for Regulatory Affairs CMC for Puma Biotechnology in Los Angeles. He provided global regulatory submission support to CMC for anti-cancer drugs in development at Puma. Duane is now Associate Director of Regulatory CMC at Halozyme Therapeutics in San Diego, where he continues his involvement in global regulatory submissions in the Oncology space.
Duane is also President of DLM Pharmaceutical Consulting Services, Inc. (DLM Pharma CSI), a company he formed in May of 2015 to provide regulatory CMC submission support to the pharmaceutical industry in drugs, biologics, and combination products.
He is a Diplomate of the American Board of Criminalistics, transitioning to Emeritus status in 2017. He continues his participation in the field of criminalistics as a member of the California Association of Criminalists where he lectures on the subject of Quality, and as a Fellow of the American Academy of Forensic Sciences. To the best of his knowledge, Duane is the only individual on this planet who has a dual certification in regulatory affairs and criminalistics, which explains his professional interest in pharmaceutical forensics – the study of counterfeit drugs.