Steven is currently working as a consultant and is assessing drug manufacturing facilities and 503A and 503B pharmacy compounding facilities to help ensure compliance with the regulatory requirements. Prior to this, he worked as a Lead Consumer Safety Officer at the FDA, having worked at the agency for 11 years; his main
focus was aseptic manufacturing. To this end, he assessed aseptic fill procedures and aseptic technique as performed by the manufacturer, as well as the maintenance of the required Class 1 environment. He also reviewed terminal sterilization procedures for products requiring such as well as blow-fill-seal technology. Steve started off as a microbiologist, where he reviewed NDA, ANDA and INDs for sterility assurance methodologies, and then moved into a facility inspector role with the Baltimore District Office then later with the elite FDA Foreign Cadre. He was also responsible for providing training to less senior inspectors on how to perform a wide variety of inspection types, including sterile injectable manufacturing facilities.

Steve has performed at least 65 foreign and domestic inspections, with the majority being aseptic processing or terminal sterilization inspections. He has issued 483 observations and performed follow-up inspections to ensure compliance with warning letter notifications. During team inspections as a lead inspector, he would distribute the
workload for the inspection and quality check other inspectors’ reports.

Before joining the FDA, he gained his understanding of small-scale manufacturing including chemical synthesis, separation technologies and aseptic processing in a basic research laboratory when working as a research biologist. As a professor of microbiology, Steve gained transferable skills in management by lecturing, coaching and developing students by giving constructive feedback.