Wilmington, NC - The biotech industry is undergoing a dramatic transformation in how and where it manufactures critical therapies. Spurred by regulatory shifts, national security concerns, and the growing volatility of international trade, many companies are rethinking their reliance on China-based Contract Development and Manufacturing Organizations (CDMOs). But as the pendulum swings toward North America and Europe, a pressing question looms: does domestic infrastructure—and the talent to support it—have what it takes to meet soaring demand?
Why the Shift Is Happening
Geopolitical Pressure & the Biosecure Act: The legislative landscape is tightening. The proposed Biosecure Act, among other measures, aims to reduce dependency on foreign manufacturing for sensitive biopharmaceuticals, including biologics and mRNA-based therapies. This policy backdrop is pushing companies to reconsider where and how their supply chains are anchored.
Trust and Transparency: Concerns around intellectual property protection, data integrity, and auditability continue to plague overseas CDMOs, particularly in regions where regulatory standards and enforcement can be inconsistent.
Tariff & Trade Uncertainty: The unpredictable nature of trade policies—coupled with escalating tariffs—adds further cost and risk to offshore manufacturing strategies. Companies are now placing a premium on stability and control, even if it comes at a higher up-front cost.
The U.S. CDMO Boom
As offshoring loses appeal, CDMOs in the U.S. are racing to expand. Companies like Resilience, Lonza (Portsmouth), and Fujifilm Diosynth are pouring capital into new facilities and expanding existing ones. The influx of venture funding is accelerating this trend, fueling rapid growth—but also revealing a new constraint: human capital.
Biotech companies, especially those in the emerging and mid-cap segments, are increasingly seeking U.S.-based partners for IND-enabling and clinical-stage programs. For many, proximity and regulatory familiarity are proving just as valuable as technical capability.
The Talent Bottleneck
The domestic CDMO surge is bumping up against a significant bottleneck: skilled labor.
Specialist Shortages: Roles such as process engineers, QC specialists, validation leads, and MSAT professionals are in high demand—and short supply. The speed at which facilities are being built often outpaces the industry’s ability to staff them.
Leadership Gaps: The same shortage applies at the leadership level. Experienced tech ops and CMC executives are being tapped for scale-up projects across the country, but the pool of talent with end-to-end CDMO experience is thin.
Operational Impact: The talent crunch is already affecting timelines. Delays in tech transfer, quality oversight, and batch release are increasingly tied not to equipment issues, but to hiring gaps.
What This Means for Biotech Companies
This new landscape demands a new approach.
Rethinking Vendor Due Diligence: It’s no longer just about facility capacity or cost. Today’s due diligence must factor in leadership caliber, workforce stability, and a partner’s regulatory track record. A sparkling GMP facility means little without a team that can run it reliably.
Hybrid Manufacturing Models: Biotechs are beginning to explore hybrid models that blend in-house manufacturing with strategic outsourcing. This approach allows for greater control over critical steps while managing risk and scalability.
Hiring for Strategic Execution: Perhaps the biggest takeaway is that operational talent is now a core strategic asset. Biotechs are increasingly seeking CMC leaders who not only understand manufacturing science but also how to navigate the evolving CDMO ecosystem.
The Road Ahead
As biotech’s center of gravity shifts back to the U.S., the infrastructure race is on. But it’s not just a matter of building cleanrooms and bioreactors. The CDMOs that will win in this new era are those that can scale with precision—because they’ve invested in the right people as much as the right equipment.
For biotech companies, success hinges not just on choosing the right partners, but on hiring the leaders who can manage those relationships and drive execution across a complex and shifting landscape.
-Mike Smth, Partner, Prestige Scientific
About Prestige Scientific:
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders. We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. We have dedicated experts in eleven practice areas that mirror a typical biopharma company, allowing us to support our client's growth from Discovery through Commercial.
