Across health care, life-sciences labs and pharmaceutical companies, the world of biotechnology is brimming with career opportunity. Biotech research and development depends on people who can keep projects on track and know how to navigate the industry’s complex rules.
“If you don’t have people who understand this area of regulation, you can’t get your products to market,” says David Hammond, a Seattle-area clinical and regulatory consultant.
Here’s a look at three in-demand jobs in the biotechnology sector — and what you need to know to join the industry.
Biomedical Regulatory Affairs Manager
Businesses that develop medical or pharmaceutical products have to follow a maze of rules set forth by regulatory agencies, such as the U.S. Food and Drug Administration (FDA).
Biomedical regulatory affairs managers have expertise to help companies meet these standards. They shepherd companies through the process of product approvals, labeling, marketing, and advertising claims. They also help manage problems and product recalls.
Working in regulatory affairs doesn’t require particular science or tech training. But, Hammond says, a background in communications or English can be helpful — the job includes a lot of writing. Programs like the UW Master’s of Biomedical Regulatory Affairs or the UW Certificate in Biomedical Regulatory Affairs can also help people get familiar with the field.
O*NET projects that through 2030, jobs for people who manage regulatory affairs will grow 18% in Washington state. That’s driven, in part, by Seattle-area companies that are developing medical devices, biologics and medical technologies powered by computer science and artificial intelligence.
“Engineers and scientists are great at the inventions,” Hammond says. “But the reality of making a product — that falls to regulatory affairs. They understand how they’re going to work with the FDA.”
Biotechnology Project Manager
Biotechnology project managers are key players in bringing new pharmaceutical, therapeutic, and life-science products to market.
These project managers work in biotech labs and R&D environments to define, scope and staff projects. They build relationships among sponsors and stakeholders, and they estimate timelines, costs and risks. Biotechnology project managers must also have specific knowledge about product development and clinical research.
For example, Bart Staker is a project manager for the Center for Infectious Disease Research at Seattle Children’s Research Institute. During the coronavirus pandemic in early 2020, he helped his research team rapidly pivot to study the virus that causes COVID-19.
Staker also shares his expertise as an instructor for the UW Certificate in Biotechnology Project Management. In addition to project management principles, his students learn about good laboratory practices, quality systems and manufacturing, and how FDA rules, regulations and safety measures can impact a project.
According to O*NET, jobs for people who specialize in project management will grow 7% nationally through 2031, and by 20% in Washington state through 2030.
Clinical Research Coordinator
When companies need to test new medical devices, drugs or biologics, clinical research coordinators work directly with human subjects — the people who take part in clinical trials.
Mindful of ethics and privacy, clinical research coordinators work with doctors to identify people eligible for clinical studies. They collect and manage data, as well as communicate with patients during the consent process. They don’t need medical background, says Hammond, who is an instructor for the UW Certificate in Clinical Trials. But some experience in health care can be useful, such as previous work as a nurse or lab technician.
Jobs for clinical research coordinators and other natural sciences managers are projected to grow 6% nationally through 2031, and at least 20% in Washington through 2030, according to O*NET. Across the Puget Sound area, these jobs are part of clinical-research teams at most major hospitals and research universities — including Evergreen, Swedish, Overlake, Virginia Mason, Seattle Children's and the University of Washington.
Clinical research coordinators also work at large practices, such as Polyclinic, and private or nonprofit research groups, such as Bristol-Myers Squibb and the Fred Hutchinson Cancer Research Center, Hammond says. He adds the government also needs clinical research coordinators for federal agencies that provide health care for millions of Americans, such as Veterans Affairs and the Department of Defense.
“They need to find better, cheaper ways to treat conditions,” Hammond says. “And that’s sometimes what clinical research is about.”
Get Started or Ahead in Biotech
Interested in starting or advancing your career in biotech? These UW certificates and degrees can help.