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Accuracy is vital in pharmaceutical manufacturing — so much so that the reagents used to test new products must themselves be tested regularly. Donald Conover works in quality control at a Merck plant that manufactures vaccines. He talked to 91亚色传媒 Today about the strict regulatory environment and his experience trying a series of jobs before he landed where he is now. This interview has been edited.

Name: Donald Conover

Current position: Quality control specialist, Merck

Career path: B.S., molecular biology, University of Prince Edward Island

First job outside of academia: Consultant scientist, Aerotek (a staffing agency)

Favorite molecule or protein: Titin. It’s the largest known protein, with the human version containing about 34,000 amino acids.

What does it mean to work in quality control at a vaccine manufacturing plant?

I work with a very specific part of quality control, on the critical reagents that are used to release vaccine products to the global market. Release testing uses set standards and known quantities to test against; we maintain those materials.

My part of the group monitors 27 different reagents. We’re responsible for understanding how these materials are used and the best way to maintain them and qualifying new lots. My standard day is a lot of reading and writing reports and interpreting data from our testing labs. We also work with the regulatory filing group all the time.

How did you get involved in this kind of work?

I started working with Merck through a different group, under a temporary contract. Then I went to an oncology research company — but I really didn’t like research. I found out I like the structure of a GMP (good manufacturing practice) environment. In a GMP space, you’re following the rules and guidelines; you have to have written procedures and protocols, and you have to receive certain trainings before you do anything.

The research position I was in didn’t have a lot of that. I would be asked to do a flow cytometry experiment, but that wasn’t anything that I had extensive practice in. I found it very difficult to get my staining correct, or to handle the cells, because there wasn’t that training procedure. They gave me ample chances to succeed, and I can honestly say I tried my hardest, but it was just not a good fit.

So when Merck reached out to me and said, “Hey, we have an open full-time position in our group again — would you like to come back?” I was like, “Yes!”

Tell me about the training requirements for your job?

You get trained on the job on systems for document retention, for recording laboratory events, reporting test results, basically everything. You’re trained how to properly review a document and check for errors. Then there are annual refresher courses and retraining any time one of the procedures gets updated. There’s a whole group dedicated just to managing the trainings.

I’ve read recently about labor shortages in biotech and biomanufacturing. Have you experienced that?

What I’ve seen is more the use of temporary or contract workers instead of full-time positions. One of the people I work with, the lead for one of our franchises, is on a contract. If she leaves or her contract expires and isn’t renewed, it’ll take somebody four or five months to pick up. When I was with my current group the first time, as a contractor, I had knowledge of the franchises I was working on; then I left, and it fell to somebody else who was less experienced to figure out what was going on.

What’s your next step?

That’s a hard question. I like what I do and the people I work with. I might prefer a more lab-based role, but at the same time, being in this role (this year) has been an absolute blessing — when I’m working from home, my daughter stays with me. Something Merck supports is broadening your experience by trying out different departments. I might do that.

A lot of my career has been like, “All right, what’s my next step?” In the last 10 years, the longest I’ve stayed in one position was three years. Sometimes another opportunity came along. In one job, I loved the work, but driving four hours a day in Philly traffic was just too much — I was missing too many things with my daughter. I learned that work–life balance is very important to me.

It’s taken a lot of moves and reevaluations of where I was before I finally got to this job. I think that’s becoming more and more common.

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