GBI Biomanufacturing, Inc., a contract development and manufacturing organization (CDMO) specializing in complex biologics announced the appointment of Jesse McCool, Ph.D., as Chief Executive Officer. Dr. McCool joined GBI in late 2025 and most recently served as President and Chief Operating Officer.
GBI, Dr. McCool has led initiatives focused on commercial readiness, operational excellence, inspection readiness, and strengthening the company's delivery capabilities. Under his leadership, GBI successfully continued it's commercial-readiness program for its client's Biologics License Application submission, improved project execution to strengthen client satisfaction and support longer-term partnerships and introduced innovative new service offerings into the market.
"Since joining GBI, Jesse has demonstrated a strong commitment to our clients, our mission, and the disciplined execution and innovation required to position the company for its next stage of growth," said Karl Pinto, Chairman of GBI's Board of Directors. "The Board is confident in Jesse's ability to lead GBI as we build toward commercial-scale biologics manufacturing and expand our capabilities for early-stage and complex biologic programs."
Dr. McCool has also helped reinvigorate technology and innovation at GBI, which has been a core part of GBI's identity over its thirty-four-year history. Driving this is the company's investment in SmartScale™ GMP, the industry's first ever integrated CMC platform designed to accelerate the progression of early-stage biologics from gene to GMP drug product for first-in-human clinical studies through a rapid, efficient, and compliant small scale manufacturing approach.
"I am honored by the Board's confidence and excited to lead GBI through this important next chapter," said Dr. McCool. "We have a talented and dedicated team, strong scientific and manufacturing capabilities, and a clear opportunity to serve clients from early development through commercial supply. Our focus will remain on quality, reliable partnership and delivery, disciplined execution, and technology innovation that helps our customers bring important biologic therapies to patients faster."