By Donna Matuizek
Beginning with Bare Earth
There’s something uniquely exhilarating—and a little terrifying—about standing on a patch of bare earth, knowing that one day it will become a fully functional biotech manufacturing facility. I’ve had the privilege of doing just that more than once, and every time, I’m reminded that the journey from greenfield to go-live is about far more than construction schedules and equipment lists.
It’s about vision, planning, people, and patience. It’s about creating something that doesn’t just work on paper, but functions with real-world precision, consistency, and purpose. And, if you’re doing it right, it’s about building a culture of quality from day one.
From my experience leading the design, build, and qualification of clinical and commercial facilities—sometimes under tight timelines and during global disruptions—I’ve learned some valuable lessons. Whether you’re an emerging biotech leader or a seasoned pro stepping into a facility buildout, I hope these reflections help you on your journey.
Lesson 1: Design with the End in Mind
The first step is always vision. What are you trying to build—not just physically, but strategically? Are you supporting early clinical material, full-scale commercial production, or something in between? What regulatory pathway are you on? What’s the timeline?
Too often, people jump straight into facility design without a clear understanding of the product lifecycle, future scalability, or the regulatory landscape. I’ve seen projects where the facility was beautiful, but couldn’t actually meet the intended throughput or aseptic process requirements.
When I helped lead the facility build at Just Biotherapeutics, we focused on the why before the what. That meant aligning with process development, manufacturing, QA, and supply chain early. The result? A facility that didn’t just meet regulatory expectations—it supported rapid clinical production and inspired confidence from partners.
Lesson 2: Build Quality In—Don’t Bolt It On
One of the biggest pitfalls in facility projects is treating quality as an afterthought. If QA and RA are brought in at the end to “bless” the final product, you’re already behind.
In every successful build I’ve been part of, quality was integrated from the beginning. We participated in design reviews, construction walk-throughs, equipment selection, and environmental controls decisions. We mapped out how the facility would flow, where cross-contamination risks might emerge, and how processes would be validated.
When the FDA or a client’s auditor walks into a facility, they don’t just see the walls and tanks—they see the intent and integrity behind every decision. If quality isn’t embedded, it shows.
Lesson 3: The Right People Make the Project
A facility is only as good as the people who build, qualify, and run it. I’ve worked with architects, engineers, contractors, validation teams, and regulators—every one of them crucial.
But just as important are the internal teams. Your QC analysts, QA specialists, and manufacturing engineers—they need to feel ownership and be empowered to speak up. That starts with bringing them into the project early and often. Some of my best insights came from operators pointing out how a design choice might cause workflow issues or QC staff asking how sample flow would work in practice.
At Just, we built our quality and operations teams alongside the facility. It wasn’t just bricks and mortar going up—it was a culture being built from the ground up.
Lesson 4: Audits Start Before the Facility Opens
You don’t have to wait until your first regulatory inspection to think about audits. In fact, if you do, it’s too late.
Throughout our facility build, we hosted client audits, internal reviews, and third-party walkthroughs. Not only did this prepare us for formal inspections, but it helped us catch issues early and demonstrate transparency.
I remember hosting 16 client audits in under two years at the clinical manufacturing facility—and I welcomed every one of them. They weren’t disruptions; they were opportunities to learn, improve, and build trust. That mindset paid off when it was time to build the new facility from the ground up..
Lesson 5: Agility Beats Perfection
No matter how much you plan, something will go sideways. Equipment will be delayed. HVAC will need tweaking. Processes will change. COVID might hit mid-project (ask me how I know!).
In these moments, what matters most is how you respond. Do you freeze or adapt? Do you hide the problem or engage the team?
The most resilient teams I’ve led embraced agility. We maintained open communication, made data-driven decisions, and didn’t let perfectionism hinder progress. In one case, we went from groundbreaking to GMP qualification in 18 months—during a pandemic—by staying flexible and focused.
You’re Not Just Building a Facility
When I look back at the greenfield site project, I don’t just remember the floor plans or qualification protocols; I also remember the people. The early morning site meetings. The late-night validation runs. The pride in getting that first successful batch.
Yes, we built cleanrooms, validated equipment, and processes. But more importantly, we built trust—across teams, with regulators, and with patients counting on our work.
If you’re embarking on a biotech facility project, know this: you’re not just building a place. You’re building possibility. And if you do it right, what you create will far outlast the construction dust.