Shawn has nearly 19 years of experience in analytical chemistry and regulatory affairs in the biotech and pharmaceutical industry. Shawn has worked in regulatory affairs with an emphasis in chemistry and manufacturing controls (CMC) since 2012. Before entering regulatory affairs, Shawn worked for over a decade in drug and process development for nucleic acid-based (oligonucleotide) therapies.
Over the course of his career, Shawn has worked at several biotech startups including St. Renatus, Dicerna, and Eyetech gaining experience as an analytical chemist. While at St. Renatus, Shawn participated in the initial approval and commercialization of the company’s first drug, supporting both regulatory and analytical efforts, including process validation and shipping validation support. He worked as a regulatory and strategic development associate director at Clinipace -a regulatory and clinical CRO. He has authored numerous CMC sections for regulatory filings including pre-IND briefing packages, IND filings, ANDA, and NDA filings including final review responses to information requests from the FDA and post-approval lifecycle maintenance. Shawn’s post-approval experience includes authoring prior approval supplements (PAS), CBE-0 and CBE-30 requests, annual reports, and APR documents. Shawn has also built tools to assist clients with managing and tracking regulatory commitments to ensure Supply Chain, Quality and Regulatory remain in compliance post-approval and during early commercialization. Shawn has expertise in assisting companies with analytical development plans and managing relationships with analytical CROs. He has experience in writing and reviewing validation protocols and final reports, and supporting pre-validation readiness efforts.
Shawn earned a Bachelor of Science in chemistry from Texas Tech University and a Doctor of Philosophy in chemistry with a focus on chromatography and mass spectrometry from University of Texas at Dallas. He completed a post-doctoral fellowship at the University of Texas Southwestern MedicalCenter working on the Human Genome Project (HGP) to develop the MerMade, a high throughput oligonucleotide synthesizer which has become a widely accepted synthesis technology for nucleic acids. Heis also RAC certified through the Regulatory Affairs Professional Society.