Shawn Knopp, PhD
Shawn Knopp serves as an Advisor for Pearl Pathways. He has over 15 years of experience in multi-disciplinary life science roles including project management, product development, regulatory, engineering, and manufacturing. Shawn’s extensive leadership positions in Product Development, Technical Operations, Quality, and Project Management at top industry companies including Pfizer, Johnson and Johnson, Baxter Healthcare, and GSK allow him to confidently meet clients’ needs in a number of key areas including quality systems, process improvement, regulatory submissions, supply chain, manufacturing strategy, IT implementations, and Quality Integrations.
As an advisor for Pearl Pathways, Shawn is responsible for providing expert advice and project management oversight for complex regulatory, quality compliance, system remediation, and clinical life science projects for clients. Shawn evaluates manufacturing facilities, labs, clinical sites, contract research providers, and quality units for compliance with current GXP US and global health authority regulations. He also leads regulatory submissions such as IND, IDE, NDA, BLA, PMA, 510k, and their global counterparts including CE Marks.
Shawn is recognized in the Life Science industry for his effective communication, strong data analysis and problem solving skills, and achieving project deliverables within negotiated timelines. His specialties include quality systems, product and process development, and continuous improvement.
Shawn also has an accomplished educational background including a Bachelor of Science in Chemical Engineering from the University of Louisville, a PhD in Industrial Pharmacy/Pharmaceutics from Purdue University, and an MBA from Elon University’s Martha and Spencer Love School of Business.