ElevateBio Taps Steven Falcone as COO

ElevateBio, an advanced therapy CDMO and gene editing services partner, has appointed Steven Falcone as Chief Operating Officer (COO).

Falcone brings more than 30 years of experience across technical operations, inspection readiness, quality systems, supply chain, and site management. He has a proven track record of transforming operations and building high-performing leadership teams that bring complex advanced therapies to people and families in need.

He will be responsible for operations and quality for ElevateBio, ensuring compliant and effective manufacturing and testing at its sites in Waltham, Massachusetts and Pittsburgh, Pennsylvania. His industry experience and approach to operations are key to delivering on ElevateBio’s mission to reduce the cost of production of advanced therapies.

“Steve joins ElevateBio at a pivotal moment as we ready our Waltham site for its first commercial product and expand into our new site in Pittsburgh,” said Chris Murphy, CEO of ElevateBio. “We are completely rethinking how advanced therapy plants are operated to help increase access to these transformative medicines. Steve’s decades of experience in commercial operations and quality system transformation make him the ideal person to lead this effort.”

Experience

Falcone joins ElevateBio from Novo Nordisk, where he served as Vice President of Quality Complaints, Audit and Inspections, and Quality Intelligence, setting strategic direction for the company’s global audit, inspection, and complaint programs. His previous roles include Chief Quality Officer for Brammer Bio (acquired by Thermo Fisher) and VP and Senior Director at Thermo Fisher where he transformed their inspection readiness and external engagement programs, as well as supported creation of new business services for advanced therapies including plasmid, mRNA, cell therapy, and regulatory affairs offerings. Prior roles include VP of Quality at Sanofi Genzyme and various quality and operational roles at Amgen, Solstice Neurosciences, and Bayer.

Across his career, Falcone has led the quality and compliance strategy behind the commercialization and global launch of numerous marketed products, with deep expertise in technology transfer, commercialization, and inspection readiness across multiple jurisdictions. He received his B.S. in Chemistry from the University of California, Berkeley.

“ElevateBio is shaping the future of advanced therapies through manufacturing and novel technologies, built on a long-standing commitment to quality and innovation that enables our partners to accelerate drug development,” said Falcone. “I am honored to join ElevateBio and lead the operations that will help make advanced therapies more accessible to patients who need them.”