MS in Biotechnology Innovation & Regulatory Science (Hybrid)
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Zachary Wilderman, Senior Quality Assurance Specialist
AstraZeneca Pharmaceuticals, LP
In 2015, I earned my Bachelor of Science in Biochemistry from the University of Southern Indiana and began my career as a lab analyst at Bristol-Myers Squibb. By 2016, I had transitioned to AstraZeneca Pharmaceuticals as a Quality Control Analyst. Over the years, I progressed to the role of Quality Control Scientist in 2020.
As a Quality Control Scientist, my responsibilities included overseeing the transfer of analytical methods in and out of the site and ensuring compliance with current Good Manufacturing Practices (cGMP) for laboratory testing methods and procedures. This experience inspired me to deepen my knowledge of regulatory science, which ultimately led me to the BIRS program.
I first learned about the BIRS program through a coworker who was enrolled in the course and shared how much value they gained from the course. Seeing their directed project poster in the lab further convinced me that the program’s content was practical and directly applicable to the pharmaceutical industry.
One of the most rewarding aspects of the program was the directed project. I proposed improvements to existing analytical testing methods, showing how these changes could be regulated from an FDA perspective. This project allowed me to apply the knowledge I gained in the program to my daily work, offering real, practical benefits to my team.
If any aspect of the program interests you, apply. I initially thought I would be most interested in manufacturing controls, but I quickly became fascinated with new drug applications, particularly in my first year. You also get to learn alongside other passionate professionals from both inside and outside the pharmaceutical industry, which adds even more value to the experience.
The BIRS program provided me with two significant benefits. First, it gave me a deeper understanding of the pharmaceutical industry and the regulatory processes that ensure product safety and efficacy. Second, it connected me with a network of like-minded professionals who share a passion for the industry.
Earning my degree from Purdue has been one of the best decisions of my professional life. While I originally enrolled to learn more about the pharmaceutical industry, the program helped me clarify my career goals and pinpoint where I wanted to develop further. After graduation, I was promoted to a Senior Quality Assurance Specialist role in inhalation research and development at AstraZeneca, where I now help review and release clinical trial products for Investigational New Drugs. The BIRS program was pivotal in helping me reach this career milestone.