Raleigh, North Carolina, United States
Experienced Executive Director of Clinical Manufacturing with a demonstrated history of working in the pharmaceuticals industry. Strong operations professional skilled in U.S. Food and Drug Administration (FDA), Biologics, Good Laboratory Practice (GLP), Validation, and GMP.
Lead integrated biologics clinical manufacturing operations across multiple U.S. sites, driving alignment, scalability, and operational excellence within Pfizer’s Bioprocess R&D manufacturing network. -Successfully integrated global cell banking operations in Andover, MA and St. Louis, MO into a unified Bioprocess R&D manufacturing network, strengthening strategic alignment and delivery capability -Oversee multi-site manufacturing operations supporting Pfizer’s biologics clinical portfolio, ensuring reliable supply, regulatory compliance, and operational efficiency -Foster cross-site collaboration and standardization to enhance network performance and readiness for pipeline growth
Directed Pfizer’s expanding clinical drug substance manufacturing network, leading large-scale facility development, integration, and multi-site operations. -Led the design, start-up, and operational ramp of the Andover clinical manufacturing facility, significantly expanding Pfizer’s clinical biologics capacity and capabilities -Integrated a newly acquired gene therapy manufacturing site in Chapel Hill, NC into Pfizer’s network, enabling advancement of emerging modality platforms -Managed end-to-end manufacturing operations across Andover, St. Louis, and Chapel Hill, delivering clinical supply for a growing and complex biologics portfolio -Built and developed high-performing teams while strengthening operational discipline, quality systems, and cross-site coordination
Progressed from engineering into operational leadership within a multi-product bioprocessing facility, driving the transition from start-up through full-scale clinical manufacturing. -Played a key role in facility design, commissioning, and start-up as a bioprocess engineering leader -Transitioned into leadership of clinical manufacturing operations, overseeing production delivery for microbial and mammalian platforms -Implemented lean manufacturing principles to improve efficiency, throughput, and operational consistency -Led multiple production teams in delivering clinical drug substance to support Pfizer’s expanding biologics pipeline
Supported large scale manufacturing plant start up for growth hormone production. Transitioned to Pfizer role via acquisition through Pharmacia.
Process engineer support for enzyme extraction and purification processing. Transitioned to supervisor role in biological buffers production.