Biotech and biochemical engineering sit at the intersection of science, technology, and innovation—and right now, they’re moving at breakneck speed. From developing next-gen gene therapies to scaling up novel biologics, the pressure is on for companies to deliver. But amid the promise, there are very real challenges facing the industry.
At Bothwell Engineering, we work directly with leading biotech, pharmaceutical, and cell and gene therapy companies across the country, helping them build the facilities, teams, and operations needed to succeed. Whether we’re supporting equipment validation or staffing a high-stakes GMP run, we’re in the trenches—so we’ve seen firsthand the top issues weighing on the biotech and biochemical engineering space today.
Here’s a closer look at what’s shaping the field—and how we help our partners overcome it.
The biotech industry has never faced more intense regulatory scrutiny. Between evolving FDA requirements, EMA updates, and region-specific compliance hurdles, staying GMP-compliant is a full-time job. This isn’t just about paperwork—it’s about making sure your equipment, processes, and people are ready to manufacture safe, effective therapies.
Many companies come to Bothwell with a clear goal: be ready for GMP runs. But that readiness takes years of preparation. Our consultants help clients validate equipment, manage projects, and ensure operational excellence across every phase—from facility buildout to production scale-up. Because when the FDA walks through your door, there’s no room for guesswork.
Ask any hiring manager in biotech and biochemical engineering what keeps them up at night, and the answer is the same: talent. With the boom in cell and gene therapy, the demand for experienced engineers and operational consultants has exploded. But the talent pool hasn’t grown fast enough to keep up.
That’s where Bothwell Engineering steps in. We connect qualified engineers, validation specialists, and operations pros with the companies who need them—whether it’s for a six-month equipment validation project or a long-term facility expansion. We also prioritize the well-being of our consultants, offering competitive salaries and opportunities at every experience level. Because we don’t just want to place people—we want to build careers.
Developing new therapies is expensive. The average cost of bringing a new biologic to market can run into the billions—and biotech companies often juggle R&D costs with the capital expenses of facility buildouts and equipment procurement. It’s a balancing act that’s only getting harder.
At Bothwell, we work alongside our clients to manage these challenges. Whether helping a company install and qualify new manufacturing equipment or supporting projects from the ground up, our teams help optimize timelines and control costs. We know that every delay or misstep can ripple through the supply chain—and we’re here to make sure things stay on track.
The rapid pace of innovation in biotech often outpaces a company’s ability to keep its systems updated. Legacy equipment, outdated processes, and clunky data management tools can all threaten a GMP run before it starts.
This is why Bothwell’s approach goes beyond just staffing. We bring in experts who understand the technical and operational needs of modern biotech manufacturing. Our consultants support the full lifecycle of equipment setup, from procurement and installation to validation and ongoing facility management. Our goal? Help clients close the gap between their vision and operational reality—because patients can’t wait.
Transitioning from early-stage R&D to commercial manufacturing is one of the biggest hurdles in biotech and biochemical engineering. Processes that work in a lab don’t always translate to large-scale production. That’s where a lot of companies hit a wall.
We help them climb it. Whether it’s scaling up a process for a new gene therapy or helping manage the operational complexity of a growing facility, Bothwell Engineering provides the experienced hands needed to make the leap. We’re not just about engineering—we’re about execution.
In fast-moving biotech environments, miscommunication between teams can slow down everything from facility builds to regulatory approvals. Silos between engineering, operations, and quality can turn small issues into massive delays.
Bothwell solves this with integrated support. Our teams work directly with sponsor companies to support cross-functional collaboration, bringing together engineering, operations, validation, and project management under one roof. We don’t just fill roles—we become part of the process.
Let’s Build Something Together
Looking for experienced biotech and biochemical engineering consultants? Need help getting your facility GMP-ready?
Contact Bothwell Engineering today
Let’s talk about your next project—and how we can help you get there.
