- GBI Biomanufacturing has appointed Jesse McCool, Ph.D., as Chief Executive Officer after he joined the company in late 2025 and most recently served as President and Chief Operating Officer.
- McCool will lead the CDMO’s continued move toward commercial-scale biologics manufacturing while expanding early-stage capabilities across monoclonal antibodies, bispecific antibodies, recombinant proteins, ADCs and bioconjugates, cell-based products, and other complex biologics.
GBI Biomanufacturing, Inc., a contract development and manufacturing organization (CDMO) specializing in complex biologics, has appointed Jesse McCool, Ph.D., as Chief Executive Officer. McCool joined GBI in late 2025 and most recently served as President and Chief Operating Officer. In his new role, he will lead the company’s continued transformation into a commercial-scale manufacturing partner.
Since joining GBI, McCool has led initiatives focused on commercial readiness, operational excellence, inspection readiness, and project execution. The company said these efforts included continuing its commercial-readiness program for a client’s Biologics License Application submission, improving project execution to strengthen client satisfaction, and introducing new service offerings.
McCool has also supported GBI’s technology and innovation efforts, including investment in SmartScale™ GMP, which the company describes as an integrated CMC platform designed to advance early-stage biologics from gene to GMP drug product for first-in-human clinical studies through small-scale manufacturing. GBI said the platform is intended to provide a rapid, efficient, and compliant manufacturing approach.
As CEO, McCool will oversee GBI’s expansion of early-stage capabilities across monoclonal antibodies, bispecific antibodies, recombinant proteins, ADCs and bioconjugates, cell-based products, and other complex biologics. He brings more than 25 years of experience in biotechnology and biopharmaceutical development and manufacturing, including executive roles at Bionova Scientific, Our Blood Institute, Cytovance Biologics, and Lonza, as well as co-founder and CEO of Wheeler Bio.
“I am honored by the Board’s confidence and excited to lead GBI through this important next chapter,” said 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.”
