Leadership Volatility in CGT CDMOs: A Strategic Flashpoint

The last 18 months have sent ripples through the executive leadership ranks of cell and gene therapy (CGT) CDMOs. Site Heads. Vice Presidents of Operations. General Managers. Titles may vary, but the story is consistent: turnover is high, and the stakes have never been higher.

Behind the scenes of manufacturing partnerships and clinical progress, a more subtle challenge is unfolding – the quiet churn of those expected to build, scale, and stabilize CGT infrastructure.

1. The Stakes: Why Site-Level Leadership Is So Critical

In the world of CGT, a Site Head is not a back-office role. They’re the linchpin holding together cross-functional chaos in a business model where every client has a different process, every therapy is under regulatory scrutiny, and timelines are measured in weeks, not quarters.

From managing viral vector suites to onboarding autologous cell therapies, these leaders sit at the convergence of:

  • Technical excellence
  • GMP compliance
  • Capacity and yield pressure
  • Client satisfaction
  • Hiring, training, and retaining specialized operators

Leadership stability here isn’t just about reducing churn – it’s about preserving momentum in a field where a six-week delay can derail an entire clinical program.

And yet, leadership volatility is rising.

2. The Data: Who Moved, Who Left, Who’s Missing

Recent analysis of the CGT CDMO landscape from May 2024–May 2025 highlights more than a dozen critical leadership shifts. Among them:

  • Phillip Maderia departed his role as Site Head and Exosome Business Lead at Lonza (Lexington, MA) to become CEO of PranaX Corp, leaving a key leadership gap unfilled.
  • Jordan Ulrich stepped in as interim Site Head at FUJIFILM Diosynth’s Holly Springs facility – one of North America’s most ambitious CGT manufacturing builds – after Richard McAvoy transitioned to CFO.
  • Michael Vreeland now wears two hats at ProBio’s Hopewell, NJ site, acting both as Site Head and Interim Head of Process Development.

Meanwhile, the following companies made strategic hires to bolster leadership:

  • AGC Biologics brought in Alberto Santagostino (ex-Lonza CGT leader) as CEO.
  • Kincell Bio appointed Larry Pitcher (ex-Catalent, Brammer Bio, Thermo Fisher) as COO.
  • ProBio installed Allen Guo (ex-Janssen, Lonza) as CEO.

These moves suggest a rising trend: leaders with proven CGT experience are being aggressively courted by smaller, fast-scaling CDMOs seeking credibility and technical depth.

3. Drivers of the Turnover

Why the churn? Why now? Multiple drivers are converging:

A. M&A and Corporate Restructuring

  • Catalent’s acquisition by Novo Holdings created uncertainty across sites and functions, with high-level CGT leaders quietly exiting.
  • Thermo Fisher’s closure of its Lexington viral vector site (layoffs ongoing through 2026) eliminated roles and reshaped its viral network, forcing talent into motion.
  • Charles River Labs is undergoing a strategic review backed by Elliott Management – future divisional shakeups are anticipated.

B. New Facility Launches

  • FUJIFILM Diosynth’s Holly Springs site and AGC Biologics’ Yokohama site required new leadership from the ground up.
  • Many of these sites are launching without permanent appointments, relying on interim leaders or talent seconded from other geographies.

C. Talent Migration to Emerging CDMOs

As CGT manufacturing matures, some of the best talent is leaving big players in favor of smaller ones where they can shape culture, make faster decisions, and build from the ground up.

4. The Bigger Picture: An Industry in Transition

The broader CGT CDMO sector is undergoing a metamorphosis:

  • Demand for automated, scalable, and lower-COGs manufacturing is rising.
  • Customers expect more than capacity – they want process expertise, speed, and reliability.
  • Regulatory expectations are evolving fast, especially in Europe and Asia.
  • Therapy developers are benchmarking CDMO leadership as a signal of risk management.

In this environment, leadership turnover is no longer just an HR issue. It’s a strategic risk vector.

5. What This Means for CDMOs (and Their Clients)

For CDMOs:

  • Leadership continuity is emerging as a competitive advantage.
  • Interim appointments send signals to clients – both positive (agility) and negative (instability).
  • Poaching from rivals is increasingly common, but without culture alignment, retention becomes a challenge.

For Therapy Developers:

  • Watch for site-level instability before outsourcing critical programs.
  • Ask about recent leadership changes during vendor qualification.
  • Consider how executive flux might affect timelines, tech transfer, or regulatory readiness.

6. What Comes Next?

Expect leadership movement to continue through 2025–2026, especially as:

  • More startups exit stealth and need experienced hands.
  • Big CDMOs consolidate overlapping roles post-M&A.
  • Tech platforms (i.e., Cellares, Astraveus) demand a new kind of leader: digital-native, quality-anchored, and AI-aware.

Those who win the leadership battle – retaining their best and hiring with foresight – will command trust, margin, and share.

The CGT CDMO race isn’t just about steel and square footage. It’s about who’s at the helm.

And right now, the bridge of the ship is changing fast.

Sanderson House,
22 Station Road, Horsforth, Leeds.
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United Kingdom

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