Sean Carl completed his Master of Science in Biomedical Regulatory Affairs at the University of Washington in 2014 and now works as a quality assurance associate at Fred Hutchinson Cancer Research Center. Sean entered the masterís program with experience in biologics manufacturing. Here, he shares how earning his masterís broadened his career options and prepared him to take on new and more advanced responsibilities, especially in the clinical environment.
Can you tell us a bit about your current career?
I'm a quality assurance associate at Fred Hutchinson. The products Iím working on are early phase clinical products, mostly for T-cell therapies. I review draft records to ensure they're compliant with the IND [investigational new drug] application that the Fred Hutch investigator files with the FDA. I also review records used to manufacture drug products, and I do investigations into product failures. Plus, I develop raw material specifications and handle equipment qualifications.
How has your experience in the master's program helped you in your current position?
The degree has helped me immensely in establishing myself in the role. At my last job, I was doing QA work related to facilities, utilities and manufacturing equipment. In my current position, Iím doing similar functions, but Iím also writing and approving drug production batch records. This means I need to understand and be able to work with regulatory documents, specifically INDs. I credit the program with giving me that ability.
Iím also working on designing and implementing additional controls for our quality assurance system for clinical trials. This requires that I have a far deeper knowledge and understanding of the regulations in order to create a system that is appropriate not only to the product we're making but also to the phase of clinical investigation the product is in.
Do you think having this degree will help your career long term?
Absolutely. Having the masterís degree, along with my background, certainly opened up a lot of possibilities here at Fred Hutchinson. Also, I am now able to market myself for clinical QA, for commercial QA and to potentially go into regulatory [affairs] as well.
Can you tell us about your practicum project for the program?
My practicum was on part 11 compliance. [Part 11 is the set of FDA regulations relating to electronic records and electronic signatures]. I was working at a local contract manufacturing organization in Bothell. The company had committed to updating some of its policies as a result of an audit, and my project was to revamp their part 11 compliance policy. The companyís policy was mainly focused on the U.S. requirements, and I integrated some of the EU requirements.
For me, the benefit wasn't so much about the electronic records part as much as being able to write policy-level documents. The standard operating procedures documents I had been working on as part of my regular job were at lower levels. These policy documents sat at the top of the quality system and informed the lower documents. So I was able to, as part of the practicum, actually write policy for the company.
What did the instructors bring to the program?
They were all extremely experienced. The vast majority of the professors had real-world experience and weren't just speaking from an academic standpoint.
How did the guest lecturers contribute to your learning experience?
They were all either consultants or local subject-matter experts and had a large wealth of experience in a wide variety of products.
We had one of the inspection supervisors from the FDA come out fairly regularly. You have this impression of the FDA as being this big, monstrous agency that you can't predict. So having somebody who's fairly higher up in the local district in terms of inspections come out and tell you what he expects, what heís looking for and what they consider reasonable, it really helped us.
What did you value most about the program?
It was a professional program designed to tell you things you need to know to actually go out and do a job. It was very practical.
It was a big challenge, but in terms of professional and personal growth, having taken on the challenge and completed it, that means a lot to me.