How young professionals find success in the life sciences

This article was written for our sponsor, NCBiotech

When most people think of manufacturing, they picture long production lines where each step in the process is meticulously honed for precision and efficiency. Of course, this is by design: through continuous process improvement—studying the way things are, asking questions when things go awry, and experimenting to improve efficiency—manufacturers can remain competitive and make products that improve people’s lives.

When that product is vaccines, the manufacturing floor is known as a "regulated" space, where the FDA and other agencies provide oversight to ensure product safety and efficacy. Because the regulated space is not somewhere for experiments, manufacturers rely on the process support lab.

Emily Barefoot, associate specialist, engineering, at Merck & Co. in Durham, began her role in the process support lab in July 2022. Her work supports all of the manufacturing sites at Merck Durham as well as other sites.

"We get to do a lot of scaled-down studies with a lot less volume [than what is found at the manufacturing line]. For example, we try different filters, different vials, and different things versus what is on the manufacturing floor," she says.

Part of her work entails designing studies to guide the experiments. "We look at ways to benefit our stakeholders on the manufacturing floor and make sure we answer the questions that they want answered. Also, we do data analysis after the study to determine what story the data tells us."

Barefoot says that, until she started working at Merck, she didn’t realize all that goes into making a single vaccine vial. "It’s people like me doing continuous process improvement in the lab," she says. "It’s also the quality group making sure that each vial contains exactly what is supposed to be in it, so that it can be released to the public. It’s the validation group making sure that all the equipment is operating in a validated state and working exactly as it’s supposed to. And then there’s the deviation group. They’re sort of the investigators who work to find out exactly what happened when something goes awry so we can identify the root cause and address it to ensure it doesn’t happen again."

Along the way, Barefoot and her colleagues are also looking at ways to optimize the lab and make it a safer environment. She says this is especially important for new employees who may be less familiar with working in a lab.

Having always gravitated toward math and science, Barefoot began finding her way into biomanufacturing early in college.

"My ultimate goal freshman year was to learn what really motivates me, what I’m passionate about," she says.

Although she found health sciences and life sciences interesting, she determined a career as a doctor, nurse, or dentist was not the right fit. She had considered biomedical engineering but says it didn’t pique her interest enough to pursue it.

In her freshman year at NC State University, one project on engineering better medicines, where she discovered how chemical engineers fit into the field of medicine, changed everything.

"I realized I’d missed a big piece of understanding how everything fit together," she says. This revelation, along with a drug development course she took at the NC State’s Biomanufacturing Training & Education Center (BTEC) during the fall of her sophomore year, ignited her interest in the field.

"I also discovered through various classes and internships all of the opportunities that exist in biomanufacturing, especially in the Raleigh-Durham area," she says. "I won’t have to worry about job security. I know my skills are needed to make these medicines and vaccines to help people."

Gene therapy is another area she finds intriguing. "With autologous gene therapy, you have the opportunity to design a medicine specifically for one patient, using the person’s own blood or cells to generate a medicine just for them."

As a result of her experience working in the process support lab, Barefoot says she saw herself becoming involved in biomanufacturing at some point. "My current role is an entry-level position, but I still have a lot of responsibility. I get to own a lot of projects and be part of several different processes in the lab at Merck Durham," she says. "It prepares me for many different possible roles in the future."

Perhaps even more meaningful to Barefoot than the promise of job security and opportunity for advancement is the assurance that her work improves patients’ lives. "That will continue to be the case, no matter what changes take place in the industry," she says. "A patient will be able to benefit from the work that we do, and I know that motivation is what will keep me going throughout my career."

This article was written for our sponsor, NCBiotech