DIRECTOR OF MFG/ QA, SENIOR PROJECT MANAGER

As a seasoned biopharma professional with over 15 years of experience, Doug has vast expertise across multiple disciplines within biopharma including pharmaceutical manufacturing, quality assurance and regulatory compliance, technical training, PAI inspections, and large-scale tech transfers.  He is highly skilled in aligning manufacturing operations with regulatory expectations and driving continuous improvement. His technical skills include DeltaV, LIMS Administration, fermentation, cell lysis, TFF, centrifugation, inoculations, and aseptic transfers. He has directed end-to-end fermentation and harvest processes while optimizing equipment design and implementing single-use components to minimize downtime and enhance production efficiency. Doug has also led project management efforts for FDA PAI readiness for a new fill-finish facility while coordinating cross-functional teams to identify and implement corrective actions to resolve compliance gaps which resulted in a successful inspection with no major observations. He holds a BS in Biology from San Diego State University.