Leadership

GBI’s senior operational staff members have decades of experience in biologics and cGMP manufacturing, including holding senior positions at numerous leading biopharmaceutical companies.

Jesse McCool, Ph.D. President & COO

Steven Vorgity Vice President of Finance & Company Secretary

Chandra L. Kelley Chief Business Officer

David Schmidt Vice President of Commercial Operations

Andrew Majdoch, MSc Vice President of Technical Operations

Brent Ryals Vice President of Quality Assurance

Lance Johnson Vice President of Facilities, Engineering, Maintenance & Information Systems

Juan Roig Associate VP of Quality Assurance

Fabio Fonseca Associate VP of Analytical and Microbiology

Koey Keylon Associate VP, Quality Operations

Jesse McCool, Ph.D. President & COO

Jesse D. McCool, Ph.D., is an operations executive, advisor, and board-level leader with 20+ years of experience scaling regulated manufacturing and mission-critical operations across biotech, CDMOs, and healthcare. He has held senior leadership roles at Lonza Group, Cytovance Biologics, Wheeler Bio, Bionova Scientific, and Our Blood Institute leading greenfield and brownfield facility start-ups and scale-ups and driving operational transformation.

His background spans plasmid DNA manufacturing, monoclonal antibody development and production, and viral vector–enabled advanced therapy supply chains, with strengths in quality systems, tech transfer, and process validation. Jesse is known for disciplined operating rhythms, KPI-driven management, and culture-building that improves performance and customer experience. He earned his Ph.D. from the University of Massachusetts Amherst and completed postdoctoral studies at Dartmouth and TU Delft.

Steven Vorgity Vice President of Finance & Company Secretary

Mr. Vorgity is responsible for providing strategic direction, leadership and oversight to GBI by directing and overseeing all financial, legal, and IT activities. He reports to the CEO and serves as a member of the Executive Management Team.

He joined GBI in 2022 to provide his diverse professional experience across various industries ranging from Pharmaceutical Brand Marketing, Construction Materials, Body Art products, Life Science Medical Devices and Life Science Reagents.

Steven holds an MBA from University of Massachusetts, and a BS in Pharmaceutical Marketing from St. Joseph’s University.

Chandra L. Kelley Chief Business Officer

Chandra Kelley brings more than 25 years of experience in the biotechnology and biopharmaceutical industry, where she has built a reputation as a strategic, relationship‑driven leader who consistently accelerates organizational growth. She leads GBI’s commercial strategy, business development organization, client engagement initiatives, and long‑term growth planning as the company continues to expand its capabilities and market presence.

With a career spanning business development, strategic partnerships, and team leadership, Chandra brings a rare blend of commercial acumen, scientific literacy, and people‑centered leadership to high‑growth organizations. She is driven by an unwavering dedication to delivering unparalleled service to clients and patients, reflected in her success building strategic partnerships, leading global marketing and commercial development initiatives, and strengthening market positioning for companies navigating pivotal expansion.

Prior to joining GBI Bio, Chandra held senior commercial development roles at KBI Biopharma, Pfanstiehl, and SAFC, where she led global growth strategies and expanded key client relationships across the biopharmaceutical sector. She also serves as an Advisory STEM Board Member at Point Loma Nazarene University (PLNU), where she earned her BS in Biology, demonstrating her commitment to advancing STEM education and developing future scientific leaders.

David Schmidt Vice President of Commercial Operations

David C. Schmidt, MBA, MS, is a commercial, technical, and operational leader with nearly two decades of experience driving growth, customer strategy, and business initiatives across the biologics CDMO and diagnostic industries. His career spans business development, technical operations, and analytical sciences, providing a unique combination of commercial leadership and deep scientific expertise.

Throughout his career, David has held leadership roles at GBI Biomanufacturing, JOINN Biologics US, Wheeler Bio, Wheeler Labs, and Cytovance Biologics, where he has built commercial teams and systems, developed growth strategies, and guided programs across the biologics development lifecycle. As a founding leader at Wheeler Bio, he played a key role in establishing the company’s commercial infrastructure and go-to-market approach, contributing to significant business growth.

David brings expertise in biologics CMC strategy, analytical development, client engagement, and cross-functional leadership. He is recognized for building collaborative partnerships and helping clients navigate complex development and manufacturing decisions that accelerate therapeutic programs.

David earned a Bachelor of Science in Microbiology with a minor in Chemistry from the University of Oklahoma and later completed both a Master of Business Administration (MBA) and a Master of Science in Management of Information Technology.

Andrew Majdoch, MSc Vice President of Technical Operations

Andrew has over 20 years of experience in manufacturing biologics and biopharmaceuticals. Prior to joining GBI, Andrew was the Senior Manager – Clinical Manufacturing and Process Development at Alkermes plc, where he worked for 13 years in manufacturing (commercial and clinical) and process development.

Andrew has experience developing drug candidates in the large molecule design space focusing on recombinant therapeutic proteins. Andrew began his career with Abbott Laboratories where he worked for 7 years moving up through the ranks to become the Rare Reagents Manufacturing Supervisor overseeing the mAb production suite.

Andrew earned his Masters of Science degree in engineering and technology management from Oklahoma State University and a Bachelor of Science degree in biology from the University of Wisconsin.

Brent Ryals Vice President of Quality Assurance

Brent Ryals brings 25 years of experience in the manufacturing of biologics, small and large molecule drug products, and active pharmaceutical ingredients.

He has a successful history of building and enhancing GMP quality systems and operations for early launched and commercial product expansions, managing pre-approval and general inspection readiness leading GMP compliance efforts. Brent has a proven record of building and managing quality organizations comprised of personnel with diverse backgrounds and educations, including engineers, chemists, biologists, microbiologists, and pharmacists domestical and internationally.

Brent has worked at several major pharmaceutical companies including, AstraZeneca, Bristol Myers Squibb, Pfizer, Pharmacia, and GlaxoSmithKline in Quality and Operations focused of patient safety. Delivering strategic leadership to drive patient focus and profitable revenue growth.

Brent received his BS in Biology from Augusta State University and is a certified Six Sigma Black Belt.

Lance Johnson Vice President of Facilities, Engineering, Maintenance & Information Systems

Juan Roig Associate VP of Quality Assurance

Fabio Fonseca Associate VP of Analytical and Microbiology

Fabio Vasconcelos Fonseca holds PhD in Biochemistry and four post doctoral fellowships. Strategic and results-driven biotech executive with a strong track record of leading cross-functional teams, driving site wide operational excellence, and executing initiatives aligned with corporate and scientific objectives. Proven ability to influence stakeholders, synthesize complex data into actionable insights, and accelerate innovation in high-growth regulated environments. Known for fostering collaboration, enhancing performance, and translating scientific vision into scalable strategies.

Fabio brings more than 20 years of experience leading analytical development, Quality Control, Microbiology and Technical Operations in regulated CDMO, CTO and manufacturing organizations. His deep expertise spans advanced biomanufacturing, quality systems, tech transfer, and process validation, along with a proven ability to build strong operating and high-performance teams.

As Head of Qc/QCM and Analytical Sciences, Fabio will play a key role in advancing GBI’s mission, strengthening operational excellence, and supporting GBI continued growth as a trusted partner in the life sciences ecosystem.

Koey Keylon Associate VP, Quality Operations

Koey Keylon is a quality and operations executive with more than 25 years of experience leading GMP-regulated manufacturing, quality systems, and organizational buildouts across biologics, cell and gene therapy, and CDMO environments. He has held senior leadership roles at Catalent Pharma Solutions, Cytovance Biologics, and BioTC Oklahoma, where he has led greenfield facility start-ups, developed and scaled quality management systems, and driven operational excellence across clinical and commercial manufacturing.

His background spans quality assurance leadership, manufacturing support, and workforce development, with deep expertise in regulatory compliance, validation, inspection readiness, and quality systems design. Koey is recognized for building high-performing teams, strengthening quality culture, and partnering cross-functionally to deliver consistent, compliant outcomes. Most recently, he served as Executive Director of BioTC Oklahoma, where he led the organization from concept through full operational launch, establishing a first-of-its-kind biomanufacturing workforce training center to support the growth of the life sciences workforce across Oklahoma and the broader region.

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