Donna Matuizek didn’t set out to become a leader in biotech and medical devices. Her story is not one of overnight success or flashy job titles. It’s a story of steady work, careful choices, and deep curiosity about how things work, especially when they matter to people’s lives.
“I’ve always wanted to understand how things tick,” Donna says. “And more importantly, how to make them better and safer for everyone.”
Born in Oak Harbor, Washington, Donna grew up in a small town on Whidbey Island. After high school, she studied chemical technology at Seattle Central Community College and later earned a degree in Business Management from the University of Phoenix.
Her early career started in the 1980s at Seattle’s first biotech company, where she worked on a project that would become the first FDA-cleared HIV blood screening test.
“It was groundbreaking. At the time, people were scared. There was so much we didn’t know about HIV. We just knew the blood supply needed to be safe.”
This set the tone for her long career in Quality and Regulatory Affairs. Donna’s job, in short, has always been to ask hard questions: Is this product safe? Is it clean? Is it made the right way? And, does it meet all the rules?
Years of Quiet Impact
From 1990 to 1994, Donna worked at Immunex, a growing biotech firm in Seattle. There, she built the company’s first Quality Control lab and supported the approval of Leukine, a cytokine that plays a crucial role in the development and function of white blood cells used in cancer care.
She then moved into research at Cell Therapeutics and later joined Dendreon, where she helped develop Provenge, the first FDA-approved cell therapy for prostate cancer.
“That was a turning point,” she says. “Cell therapy was still new. It was messy and complex. But it offered hope to patients who didn’t have many options.”
At Dendreon, she rose to Director-level roles. She built teams, was a key participant during FDA inspections and international audits, and represented Dendreon while providing manufacturing and quality oversight at the clinical manufacturing sites on the East Coast.
“It wasn’t glamorous. I traveled between two sites and spent a lot of time in labs and on factory floors. But I learned to lead through significant time constraints and logistics — through listening.”
A Turn Toward Food and Back Again
In 2007, Donna took a break from full-time biotech work. She consulted on projects and, for a time, followed a lifelong passion: cooking.
She opened On The Fly, a takeout sister restaurant to Flying Fish in Seattle.
“It was a blast,” she laughs. “The hours were brutal. But food connects people in ways that science sometimes doesn’t.”
She returned to the medical device world in 2010 at Blood Cell Storage Inc., helping the company earn ISO certification and CE marking. From there, she joined AGC Biologics, where she led a successful FDA inspection for a client product and later participated in the client’s licensing audit in Copenhagen.
At Just Biotherapeutics, Donna was instrumental in building the quality systems and qualifying a clinical manufacturing facility. She was later promoted to Vice President of Quality and helped complete a commercial site from the ground up during the COVID-19 pandemic.
“It was intense. So much had to be done remotely. Over the course of 18 months, we assured the entire facility would be suitable and could be licensed as a commercial manufacturing site.”
Most Recent Chapter: Magnolia Medical
From 2022 to 2024, Donna worked at Magnolia Medical Technologies, a Seattle medical device company developing tools to reduce false-positive sepsis diagnoses. Her team earned FDA clearance for their next-generation Class II device.
“We weren’t just ticking boxes. We were helping solve real hospital problems — one that affects treatment, cost, and lives.”
She also grew the QA team and kept staff turnover below 5%, which is rare in an industry known for burnout and turnover.
“I believe in investing in people. If you support them, they stay. If you listen, they excel and advance in their careers.”
Life Outside the Lab
Donna isn’t all work. She’s part of a supper club and a food club. She belongs to a book club with women of all ages. She gardens — both flowers and vegetables. She’s run over a dozen half-marathons and one full marathon (Disney World, of course). She loves golf, cats, and red wine.
She also gives back. Every quarter, she cooks dinner for a women’s shelter in Burien.
“I don’t need a big stage,” she says. “I just like to do things that matter, quietly.”
Lessons From a Long Career
Looking back, Donna says she never planned to lead teams or direct departments. She just kept showing up, learning, and asking hard questions.
“Quality isn’t glamorous,” she says. “But it’s essential. You don’t notice it until something goes wrong. My job is to make sure things don’t go wrong.”
Now open to new opportunities, she’s reflecting on the past and staying curious about what’s next.
“I’m still learning. Still exploring. I think that’s what keeps it all so interesting, exciting, and rewarding. It’s a privilege to do this work; not everyone can.”
