Meet Steve Folio – Vice President of Quality and Regulatory Affairs at Argonaut
What does your role at Argonaut look like?
“As Vice President of Quality and Regulatory Affairs, I oversee four critical quality pillars,” Steve Folio begins. His responsibilities include leading quality assurance, quality control chemistry, quality control microbiology, and validation/metrology.
“Our Quality Assurance team reviews and approves—or rejects—materials entering or leaving the facility. The Quality Control Chemistry team handles all chemical and product analysis, generates certificates of analysis, and conducts ICH compliant stability testing, while the Microbiology group focuses on environmental monitoring, in-process and release testing, such as bioburden and endotoxin analysis. Lastly, our Validation and Metrology team ensures our facilities, equipment and processes meets strict regulatory standards and remain in a validated state.”
Each day, Steve balances these responsibilities with about half a dozen client meetings addressing quality issues, process analytics, and batch disposition. “As a contract manufacturer, we work with a wide range of customers and programs, so no two days are ever the same,” he says.
How does your work contribute to Argonaut’s mission?
“Our mission is to deliver high-quality drug and life science products, and that’s the foundation of what I do,” Steve Folio explains. “It’s my job to ensure patients or scientific professionals receive safe and effective medicines and diagnostic tools. Every decision we make revolves around that commitment to patient safety and product integrity.”
Steve’s work directly impacts Argonaut’s reputation and ability to meet the needs of its clients and patients, which he describes as both a challenge and a privilege.
“Our mission is to deliver high-quality drug and life science products, and that’s the foundation of what I do.”
What makes your role fulfilling?
“It’s knowing that what we do has a direct impact on patients’ lives,” Steve says. Argonaut clients include nonprofits and companies addressing rare diseases, where manufacturing might be needed for just one individual. These unique cases highlight the importance of producing high-quality treatments that directly improve lives.
Steve’s role draws on his diverse professional background, including experience as a metrologist and electronics technician in the US Navy. “I entered the biotech field in the ’90s during its rapid growth in San Diego, and it has been my professional home ever since,” he shares.
What are some challenges you face in your role, and how do you overcome them?
“Challenges can come from people, processes, or clients,” Steve Folio says. “Educating our client stakeholders about GMP (Good Manufacturing Practices) and the complexities of drug manufacturing is a big part of my role as we service clients from different stages of regulatory maturity
Internally, Steve faces the constant pressure of being the final step in the manufacturing process. “Any delays upstream from quality compresses our timelines, especially when patients are waiting for treatment,” he explains. Steve Folio and his team work closely with the manufacturing teams to address issues early, ensuring no surprises during the batch disposition process.
“Argonaut has a strong team environment where people genuinely want others to succeed.”
What advice would you give to someone pursuing a career in biotech?
“Embrace the culture and collaborate,” Steve advises. “Argonaut has a strong team environment where people genuinely want others to succeed.”
For newcomers, he emphasizes the importance of curiosity. “Learn, observe, and ask lots of questions. Building a deep understanding of processes is crucial for long-term success in this field.”
What’s next for you and Argonaut?
Steve is excited about the future, particularly the installation of a new isolated filling line at Argonaut’s newly acquired Aston facility. “It’s going to be a full-service facility with everything from water-for-injection systems to clean steam, functionally dedicated formulation suites, a four head multipurpose isolated filling line, and more” he explains. “This is a big step forward for Argonaut, and I’m thrilled to be part of it.”
Steve Folio’s dedication to quality, passion for patient impact, and deep expertise make him an invaluable leader at Argonaut. His commitment to excellence ensures Argonaut continues to set the standard in the biotech manufacturing industry.
“Every decision we make revolves around that commitment to patient safety and product integrity.”
Argonaut is a leader in pharmaceutical, combination products and IVD contract manufacturing services with over 100K square feet of manufacturing facilities. No other life science, diagnostic, or drug product contract manufacturing organization (CMO) offers broader scale, more flexibility and faster speed to market with lower risk, and less capital expenditures.
Discover how Steve Folio’s expertise can elevate your manufacturing processes—reach out to us today to learn more!
