David Dlugo
About David Dlugo
David Dlugo serves as the Associate Director of Commercial Products Manufacturing (Combination Products) at Supernus Pharmaceuticals, Inc., where he has worked since 2015. He has extensive experience in quality assurance, regulatory affairs, and product development across various companies in the medical and engineering fields.
Work at Supernus Pharmaceuticals
David Dlugo serves as the Associate Director of Commercial Products Manufacturing (Combination Products) at Supernus Pharmaceuticals, Inc. He has held this position since 2015, contributing to the company's efforts in developing and manufacturing combination products. His role involves overseeing manufacturing processes and ensuring compliance with regulatory standards. He is based in the Greater Tampa Bay Area.
Previous Experience in Quality and Regulatory Affairs
Before joining Supernus Pharmaceuticals, David Dlugo worked at MobileMedTek from 2012 to 2018 as Director of Quality and Regulatory Affairs and Director of Product Development (Consultant). He also served as a Regulatory Expert (Consultant) at ORTHOPEDIX from 2016 to 2017. His experience includes implementing quality management systems and ensuring compliance with regulatory requirements.
Engineering and Project Management Background
David Dlugo has a strong background in engineering and project management. He worked at TriVirix / UMM Electronics from 1999 to 2006 in various roles, including Project Manager and Manufacturing Engineering Manager. Additionally, he was a Sr. Product Development Engineer at Cummins Engine Company from 1994 to 1999, where he focused on advanced fuel systems.
Education and Expertise
David Dlugo studied Mechanical Engineering at the University of Wisconsin-Madison, where he achieved a Bachelor of Science in Mechanical Engineering (BSME) from 1993 to 1995. His educational background supports his extensive expertise in quality assurance, regulatory affairs, and product development within the pharmaceutical and medical device industries.
Achievements in Regulatory Compliance
Throughout his career, David Dlugo has made significant contributions to regulatory compliance and product development. He has implemented a Quality Management System compliant with ISO 14971:2019 and 21 CFR 820.30, authored a Quality Manual covering various FDA regulations, and contributed to Biologics License Application (BLA) information requests. His work includes developing Design History Files (DHF) for new drug applications.