Eli Lilly navigates the uncharted waters of standing up multiple mega sites

When Eli Lilly pledged $27 billion in early 2025 to build four new manufacturing “mega sites” in the United States, the drugmaker boasted at the time that its plans represented the largest pharmaceutical manufacturing investment in U.S. history. The capital expenditure more than doubled Lilly’s domestic manufacturing commitment since 2020, bringing the total to over $50 billion and with it a host of challenges.

To their credit, Lilly executives in their recent public speaking engagements haven’t tried to sugarcoat the hurdles the pharma giant has experienced — as one might expect from such a massive undertaking — despite the high-profile nature of the company’s investment and the extensive financial resources at its disposal.

At the INTERPHEX conference in March, Dan VonDielingen, senior vice president of global parenteral network expansion, said Lilly’s manufacturing infrastructure growth over the last six years is the first such undertaking by any pharmaceutical company — the key, he commented, is learning once and working smarter.

“We’re not perfect — we do have mistakes,” VonDielingen said. “Failure is fine. We want to fail fast.”

To grow its network, Lilly decided to scale its production sites with standardization, drawing upon lessons learned from its existing plant sites. The drugmaker has been building new multibillion-dollar manufacturing facilities designed to scale through “disciplined” replication, according to VonDielingen.

“Every time that we announce a new plant site — we’ve announced 12 of them now since 2020, five of them in the last year — we kick off three different workstreams of activity” including building the facility, procuring the equipment, and hiring the staff to make medicines in the same way, he said. 

Speaking in March at the Advancing Life Science Construction conference, Steve Marr, Lilly’s head of global facilities delivery parenteral, called the company’s building boom “unprecedented” and “transformational” but said the drugmaker hasn’t yet figured out how to manage these mega sites. Marr noted that Lilly is struggling to find the talent required for these capital projects.

“I need six top project directors — how many people out there know six project directors that have delivered on $2 billion projects?” Marr asked the audience. “We can’t build our facilities fast enough,” he added.

Victor Cruz, Lilly’s senior vice president of corporate engineering and global health, safety, and environmental, spoke recently with Bioprocess Online about the drugmaker’s expansive capital projects during the 2026 ISPE Facilities of the Future Conference.

“Lilly is standing up mega sites in areas that have historically lacked the massive utility and specialized labor infrastructure required for high-tech GMP manufacturing,” the article states. “For Lilly’s leadership, challenges lie in the complex logistics of capital delivery, the philosophy of ‘smart replication,’ and the race to ensure facilities are flexible enough to handle the next generation of therapies.”

Mega projects in resource-constrained environment

While Lilly’s investment may be one of the largest pharmaceutical buildouts, the construction and operational challenges that it faces aren’t unique to the company, as Big Pharma companies have announced planned investments totaling more than $500 billion in U.S. biomanufacturing.

In a two-part podcast, Pharma Manufacturing Senior Editor Andy Lundin spoke with Pathfinder President Steve Cabano and Mark Christopher, vice president and head of the consulting firm’s pharma division, about what it takes to successfully deliver mega-scale capital projects in today’s resource-constrained environment.

“Rising capital investment in pharma manufacturing is pushing projects to unprecedented scale, but execution strategies haven’t fully kept pace,” Lundin wrote. “As companies commit billions to new facilities they’re encountering a new set of challenges around planning, coordination, and risk management. What worked for smaller, site-based upgrades is insufficient for multibillion-dollar builds involving thousands of stakeholders, constrained resources, and increasingly complex regional dynamics.”