When Donna Matuizek started her career in Seattle’s early biotech scene, she wasn’t thinking about leading FDA inspections or writing regulatory filings. She just wanted to make a difference. Over 35 years later, she’s done all that and more.
From HIV blood tests to advanced biologics, Matuizek has had her hands on some of the most critical projects in modern medicine. But her journey wasn’t flashy. It was built through hands-on work, quiet leadership, and a focus on quality, always.
Small Town Start, Big Industry Impact
Donna grew up in Oak Harbor, Washington. In 1975, she earned a JROTC scholarship to attend college. She started her studies at the University of Washington, then transferred to Seattle Central Community College, where she earned an Associate of Applied Science in Chemical Technology.
In 2003, she graduated with honors from the University of Phoenix with a Bachelor of Science in Business Management.
“My early focus was on labs and testing,” she says. “I didn’t plan to end up in regulatory affairs. But quality pulled me in.”
Early Wins in Diagnostics
In 1985, Donna joined Genetic Systems, the first biotech company in Seattle. She helped develop the first FDA-approved HIV-1 blood screening test in the U.S.
“It was groundbreaking,” she says. “We were protecting the nation’s blood supply. It felt big because it was.”
Her next stop was Immunex, where she helped launch the QC lab and supported FDA approval for Leukine®, a GM-CSF used in chemotherapy recovery.
Cell Therapy Before It Was Cool
By the late ‘90s, she moved into cell biology research at CTI BioPharma. Then came Dendreon. There, Donna led Quality Control and later Contract Manufacturing for Provenge®, the first FDA-approved cell therapy.
“I was the field lead on the East Coast,” she recalls. “That meant long flights and tighter gloves. We were building something no one else had built.”
She helped improve aseptic process success rates and reduced product failure from 5% to under 0.5%. She also worked on the CMC (Chemistry, Manufacturing, and Controls) section of their BLA submission, critical for FDA approval.
Consulting, Startups, and CE Marks
In 2007, Donna began consulting. Projects included lot release reviews, stability data assessments, and regulatory strategy. She later joined Blood Cell Storage Inc., a small medical device company.
At BCSI, she directed regulatory and quality systems. She led CE marking and ISO 13485 certification for platelet and fertility monitoring devices.
“Smaller companies teach you how to build systems from scratch,” she says. “You wear 10 hats and learn fast.”
Scaling with AGC and Just Biotherapeutics
In 2015, she joined AGC Biologics as Director of Quality Control and Senior Manager of Regulatory Affairs. She helped lead a successful 5-day FDA inspection and supported another one in Copenhagen.
Then came Just Biotherapeutics (now Just-Evotec Biologics). Over six years, she scaled their quality operations from scratch, eventually leading a team of 35 people.
She qualified a full commercial biologics facility in just 18 months during COVID-19. “It was fast. Really fast,” she says. “But we did it. And we met all the compliance requirements.”
Her leadership contributed to a 100% success rate in GMP manufacturing for monoclonal antibodies and exosomes for clinical trial materials. She helped eight clients get INDs approved and hosted over a dozen successful quality systems audits.
Most Recently: Magnolia Medical
From 2022 to 2024, Donna served as Senior Director of Quality and Regulatory at Magnolia Medical in Seattle. She led product transfers to new contract manufacturers and validated the company’s electronic Quality Management System.
She also helped gain FDA clearance for a Class II medical device aimed at reducing false-positive sepsis diagnoses.
Beyond the Job Title
Despite her busy career, Donna keeps things balanced. She runs a supper club and a food club. She’s also a cat lover, gardener, marathon finisher, and a member of a book club.
“Cooking is my therapy,” she laughs. “And gardening keeps me grounded, literally.”
She volunteers regularly by preparing meals for a women’s shelter. She also prides herself on team loyalty. Over a 14-year stretch, she maintained a staff retention rate of over 95%.
“That only happens when people trust you,” she says. “And when you trust them and help them grow.”
Lessons From a Lifetime in Quality
Donna’s approach is simple: be thorough, stay curious, and never cut corners.
“Quality isn’t about checklists,” she explains. “It’s about protecting people. You can’t fake that.”
Her ability to build systems that scale, while staying compliant, makes her stand out in the biotech world. And her track record proves it.
She doesn’t chase headlines or try to be the loudest voice in the room. But if you’re launching a biologic or scaling a medical device, chances are you want someone like Donna Matuizek in the room.
“I just try to get it right,” she says. “Every time.”
Interview with Donna Matuizek
You’ve worked on everything from HIV diagnostics to cell therapy. What project stands out most?
“The HIV blood screening test at Genetic Systems stands out because it had an immediate national impact. We were making sure the blood supply was safe. That kind of work stays with you.”
How did you end up in quality and regulatory affairs?
“I started in labs, doing testing and analysis. However, as I delved deeper, I realized that quality was the common thread. It touches everything, labs, manufacturing, and patient safety. I got pulled in and never left.”
What’s your approach when building quality systems from the ground up?
“Start with the basics and scale smart. Focus on risk, training, and documentation. The system has to serve the product and the people, not the other way around.”
You led a commercial facility build during COVID in just 18 months. How?
“Tight planning, a great team, and constant communication. We didn’t skip steps, we just did them fast and right the first time. That made all the difference.”
What advice would you give someone entering biotech quality roles today?
“Stay curious and don’t rush. Learn the regulations, but more importantly, understand the reasons behind them. Quality isn’t paperwork, it’s protection.”
Outside of work, how do you recharge?
“Cooking is my outlet, I run a supper club. I also love gardening, wine, and reading. And I try to give back. I cook for a women’s shelter every few months. It helps keep perspective.”
