When Donna Matuizek started her career in the 1980s, she didn’t know she was helping shape the future of biotech. She just knew she wanted to do work that mattered—and do it the right way.
“I’ve always paid attention to details,” she says. “That’s where the truth is. That’s where the mistakes hide.”
Donna has worked in biotech, pharma, and medical devices for over 30 years. She’s lived in labs, clean rooms, and audit rooms. She’s built systems from scratch, led FDA inspections, and supported teams through massive product launches. Her title has changed many times, but the core of her work hasn’t.
“I help make sure products are safe, reliable, and made to consistently meet all the rules,” she says. “It’s not exciting to everyone. But it should be.”
From Small Town to Big Science
Donna was born in Oak Harbor, Washington. It’s a quiet town on Whidbey Island. After high school, she earned an associate’s degree in chemical technology. Later, she got a bachelor’s in business management while working full-time.
She started her career in Seattle at the city’s first biotech company. Her team helped develop the first FDA-cleared HIV blood test to screen the U.S. blood supply.
“That was the moment I realized science could save lives in real time,” she says. “We weren’t just doing research. We were eliminating the spread of HIV through America’s blood supply during a crisis.”
Immunex, Dendreon, and Provenge
In the 1990s, Donna joined Immunex. She built the Quality Control lab and helped get Leukine, a drug that helps cancer patients fight infection, approved.
Then, at Dendreon, she supported Provenge, the first FDA-approved cell therapy for prostate cancer. She stayed at the company for seven years, rising to Director roles. She also participated in both FDA and TUV inspections.
“I wasn’t the loudest person in the room,” she says. “But I was steady. I knew the work. And I earned trust by showing up, every day.”
She later oversaw external clinical manufacturing sites in Philadelphia and New Jersey.
Mixing Passions: Food and Science
In 2007, Donna took a new path. She collaborated in opening a takeout restaurant called On The Fly, a sister concept to the well-known Flying Fish in Seattle.
“I’ve always loved cooking,” she says. “It’s science, really. You mix ingredients, apply heat, and hope the outcome is what you planned.”
But science called her back. She consulted for medical device companies, eventually joining Blood Cell Storage Inc. There, she helped the company gain ISO 13485 certification and CE marking for its products.
Building Systems at Scale
Between 2015 and 2022, Donna took on senior roles at AGC Biologics and Just Biotherapeutics. At AGC, she successfully hosted a five-day FDA inspection and helped with an international FDA inspection in Copenhagen.
At Just Biotherapeutics, she started as Senior Director of QA and was promoted to VP of Quality. She led Quality through a greenfield construction of a new clinical and commercial site in just 18 months—during the COVID-19 pandemic.
“It was one of the hardest projects of my life,” she says. “But we did it. Remote teams. Masks. Supply chain delays. And somehow, we still made it work.”
Most Recent Chapter
From 2022 to 2024, Donna worked at Magnolia Medical Technologies. She led Quality and Regulatory teams to gain FDA clearance for a next-generation Class II device aimed at reducing false-positive sepsis cases.
“It’s the kind of product that saves hospitals time and money and saves patients from unnecessary antibiotics,” she says.
She also grew the QA team and kept staff turnover below five percent.
“Retention is about respect,” she adds. “You build a place where people feel heard and valued.”
A Life Beyond Work
Donna’s life isn’t all lab coats and compliance checklists. She’s part of a supper club and a food club, where friends meet to try new dishes and cook together. She also belongs to a book club with members of all ages and backgrounds.
She loves gardening, golfing, wine bars, and traveling. She’s run over a dozen half-marathons, and even a full marathon—at Disney World, no less.
And yes, she’s a cat lover.
“I’m not flashy,” she says. “But I love learning. I love sharing food, ideas, and laughter. That makes for a rich life.”
Looking Ahead
Donna is now open to new roles. She’s considering what company and team she’d like to join next.
“I’ve worked with small startups and big manufacturers. I’ve cleaned up messes and built from scratch. What matters to me is purpose. I want to work on something that improves lives.”
That’s the theme of Donna’s life: quiet progress. Not chasing titles, but asking the right questions. Not seeking the spotlight, but making things better from behind the scenes.
“If I’ve learned anything,” she says, “it’s that quality doesn’t happen by accident. It’s a choice made every day.”
Read more:
Details Matter: The Life and Work of Donna Matuizek
