IndEx Blog

This week, IndEx interviewed Mikayla Thompson, PhD who is currently a regulatory Affairs Manager at Biogen about her transition to and experience in industry.

How are you related to the UMass graduate school (i.e. medical school, post-doc work, graduate work, etc?) 

I graduated from the School of Biomedical Sciences in 2014. During my time at UMass, I was a student in the labs of Katherine A. Fitzgerald and Evelyn A. Kurt-Jones studying the role of IFI16 in innate immune responses to HSV-1.

Where do you currently work? What position do you hold and what do you do? 

I currently work at Biogen as a Manager in Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC). In my role I act as a liaison between the company and Health Authorities worldwide (such as the FDA) to bring therapies to approval and maintain compliance for products post approval as well. Each health authority has different regulations and it is the Regulatory Affairs professional’s job to develop the strategy to ensure that these requirements are met.

What path did you take to your current position? (Did you go directly into industry or residency after UMass, or remain in academia, either for a postdoc or another position?) 

After graduate school I completed a two-year postdoctoral fellowship at Biogen. The non-traditional fellowship consisted of two, one-year rotations; one in the Manufacturing Sciences department and one in the Regulatory Affairs CMC department. In my Manufacturing Sciences rotation, I had the opportunity to learn about the manufacturing process for Biologics and about Health Authority requirements for building quality, safety, and efficacy into a product. This background helped me in my Regulatory Affairs CMC rotation by giving me a foundation for understanding the manufacturing process expectations that are required by regulation and built into an application for drug approval. Through this fellowship, I found a passion in Regulatory Affairs CMC and moved into a full time position in the department at Biogen upon the completion of my fellowship.

Why did you decide to pursue a job in industry?

Throughout my time in graduate school, I participated in activities outside of the lab that involved managing a non-profit and volunteering my time in different organizations. I realized that I had a passion for working with people in a team environment and wanted to find a career that would combine that aspect with my scientific background. I was also drawn to a role that I felt would have direct impact on the lives of patients. Regulatory Affairs gives me a sense of purpose, as my job makes sure that people have access to safe and effective life changing therapeutics.

What resources (UMass or otherwise) did you find helpful in getting into industry after leaving UMass or academia? 

I became involved with the Biomedical Science Careers Program which gave me access to a network of professionals of color that represented a wide range of careers within the Biomedical industry. By attending their Biennial conference I learned about career options that were available to me and even found out about the postdoctoral fellowship opportunity at Biogen. I also participated in the Keck Graduate School, Bioscience Management Bootcamp. The two-week program exposed me to different career options while teaching us how to navigate the business side of biotech through classes and a capstone team project.

What advice would you give to someone hoping to pursue a position in industry after their time at UMass? 

I would advise students to get involved with activities outside of the lab that will help build transferrable skills. Companies are looking for well-rounded candidates who show that they are team players and can adapt to different environments and roles. I would also suggest that students build a strong network as early as possible. Networking not only helps you determine what careers may be a good fit for you, but also helps you build strong relationships with people who can potentially advocate for you in the future.

Click to visit Mikayla Rae Thompson on LinkedIn