Robert Roy

Rob offers more than 30 years of dedicated professional experience in all phases of advanced aseptic processing, including engineering, quality, qualification, and manufacturing operations for the pharmaceutical and biotechnology industries. He has particular technical expertise in process mapping and optimization, barrier isolation technology, single-use disposable systems, potent material handling and containment, cleaning validation, and CIP/SIP systems.

He has served in senior-level management roles directing global engineering, design, and manufacturing teams on fast-track design/build/qualification projects for clinical and commercial scale aseptic fill/finish facilities. He co-developed a flexible isolator configuration that allowed isolated formulation and fill/finish operations within a single isolator. As a director in the Global Quality Organization for a major pharma manufacturer, Rob developed quality and qualification documentation for cleaning, environmental and clean utility monitoring, and equipment and process validation programs for sterile manufacturing operations worldwide.