#United States #Fort Lauderdale, Florida #Biologics #GBI Biomanufacturing #Jesse McCool

Jesse McCool Takes the Helm as CEO of GBI Biomanufacturing

In a significant leadership transition, GBI Biomanufacturing, Inc., commonly referred to as GBI, has announced Dr. Jesse McCool as the new Chief Executive Officer. This appointment, effective immediately, positions McCool to reinforce GBI's mission to excel in commercial-scale manufacturing and expand its capabilities in biologics development. Dr. McCool has been with GBI since late 2025, serving prominently as President and Chief Operating Officer before stepping into this top leadership role.

Dr. McCool brings over 25 years of expertise in biotechnology and biopharmaceutical development. His previous roles include executive positions at several prestigious CDMOs and life science organizations such as Cytovance Biologics, Lonza, and co-founding Wheeler Bio. His extensive experience in the industry uniquely positions him to navigate GBI towards greater success.

Under his leadership, GBI has focused on key initiatives aimed at improving commercial readiness and operational excellence. Since Dr. McCool joined, GBI has achieved several milestones, including successful project executions that have enhanced client satisfaction and paved the way for long-term partnerships. The introduction of new service offerings also reflects the company's commitment to innovation and adaptation in a competitive environment.

Karl Pinto, Chairman of GBI's Board of Directors, expressed confidence in McCool's capabilities to steer GBI as it embarks on its next growth phase. Pinto remarked, “Jesse has demonstrated a strong commitment to our clients and the discipline needed to position the company for growth,” recognizing the advancements that have taken place under McCool's watch.

One of the pivotal aspects of GBI’s growth strategy will be through the advancement of its SmartScale™ GMP initiative, which McCool has re-energized. This innovative platform is heralded as the industry’s first integrated CMC framework designed specifically for the accelerated progression of early-stage biologics from development to clinical studies. It aims to streamline the manufacturing process while ensuring compliance and efficiency, providing clients with a robust pathway to bring their therapies to patients more quickly.

“As I take on this role, I am honored and excited to lead GBI through this crucial phase,” said Dr. McCool. “We have a dedicated team, strong scientific and manufacturing capabilities, and clear opportunities to support our clients through their development journeys to commercial supply.” His focus as CEO will be on quality, reliable partnerships, and the innovative use of technology to enhance delivery and performance throughout GBI’s operations.

As the new CEO, Dr. McCool's first order of business will likely be to continue to transform GBI into a leading commercial partner adept at navigating the complexities of biologic manufacturing. GBI's ambition includes expanding its offerings to encompass monoclonal antibodies, bispecific antibodies, recombinant proteins, ADCs, cell-based products, and other intricate biologics.

With Dr. McCool at the helm, GBI Biomanufacturing is set to embark on an exciting journey. The company’s rich history combined with McCool's dynamic leadership sets the stage for groundbreaking developments in the biomanufacturing sector, inspiring confidence in clients and stakeholders alike. GBI aims not only to maintain its status as a proven turnkey CDMO partner but also to venture into new territories of innovative biologics, assuring a bright future ahead.

About GBI Biomanufacturing, Inc.

GBI Biomanufacturing operates from Florida and is a full-service biopharmaceutical contract development and manufacturing organization (CDMO). For over three decades, GBI has carved a niche in reducing manufacturing risks for developers of complex biologic therapies, providing integrated solutions from process development to cGMP drug substance and product manufacturing. With experience in supporting numerous large-molecule programs and regulatory filings, GBI exemplifies commitment to scientific rigor and customer focus, making it an ideal partner for companies aiming to deliver life-saving therapies to patients faster.