A Victim of Its Own Success: Biotherapies Face Staffing Shortages

April 11, 2022

The explosion of biotherapies has been life-changing — and even life-saving — for patients with a wide range of diseases. But this success, and the growing place for biotherapies in medical treatment, requires an ever-expanding workforce to meet the demands of research and manufacturing.

Therein lies a problem. “Five years ago, biopharmaceutical manufacturing companies felt that while they could find staff then, they would reach a pinch point for talent as cell and gene-based therapies take off,” said John Balchunas, who is the workforce director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). “However, everything that I’m hearing these days says that we’re in a crisis mode now. There's not a single company that I've talked to that doesn’t quickly acknowledge that they're having trouble finding the people they need.”

Not only do cell therapy laboratories process standard of care products, like bone marrow, peripheral blood and cord blood-derived stem/ progenitor cells, they also support a dizzying array of biotherapies in clinical trials. “Standard of care products — those that have that been  recognized or approved by FDA — are our bread and butter,” said Suzanne Dworsky, administrator of stem cell transplantation and cellular therapy at MD Anderson Cancer Center in Houston. “But we also support around a hundred clinical trials. Many of those products come through our cellular therapy laboratory.”

The capacity to meet those needs is stretched though. “Even with our 60 people in our space, which is about 35,000 square feet, we're crowded; and we run from 7 in the morning till 11 at night, Monday through Saturday. That covers almost three shifts,” said Dworsky.

Keeping Good People

So, what’s behind the crunch? For starters, keeping good staff is challenging. One of the challenges with medical technology (also known as laboratory science) is that while it’s a great career, it doesn't even come close to competing with nursing or even technology.

There are a number of reasons why it is hard to keep trained and competent staff. “Within cell therapy in particular, there are a lot of jobs that require the technical skills gained in 2-year technical degree programs,” said Balchunas. “But if you talk to some of the big companies in cell therapy, they're predominantly hiring people with bachelor's degrees. While this makes sense in startup mode, these same employees are getting bored as companies shift gears and ramp up production. These are jobs that are beautiful for folks with less than a bachelor's degree, but I don't think the industry has fully embraced that yet.”

Another issue is that cell therapy jobs generally do not offer what attracts and keeps employees. “If you'd asked me about keeping staff 2 years ago, I would've said we're hemorrhaging. Since then, I have negotiated/renegotiated probably at least three different times with our HR compensation group, saying that we're losing well trained employees. Other facilities were offering things that, as an academic institution, we could not even touch when it came to salary, benefits and incentives,” said Dworsky.

It took a lot of negotiation with the people responsible for HR compensation and showing the data on attrition and why people were leaving and why they were unable able to maintain staff levels at MD Anderson’s cell therapies lab. “We had to develop a very aggressive career ladder, where someone comes on board, works for 12-18 months, and if they can demonstrate that they are competent at a set of skills, they can progress to the next level — and again, in another 2 years if they show that they are competent at another set of skills,” Dworsky said. “It was critical to do this, and it helped a lot.”

“The salaries are not stellar in this field,” said Bill Ward, cellular therapy operations manager at Novartis Oncology. Ward has managed and worked in cell therapy labs at Saint Luke's Health System in Kansas City, the University of Colorado and the University of Nebraska. “In my experience, hospital administration often does not understand what is going on in these labs because it's not a traditional lab, where they do a market analysis of the cell therapy technologists.”

“It's been tough trying to convince hospital administrations that another full-time employee (FTE) was necessary just to handle increased quality management work,” he said. Almost all cell labs have a quality manager or coordinator, but it's often been an uphill climb to try to get that FTE.

Add to this the radical growth in biotherapies. “With the rise of immunotherapies and CAR [chimeric antigen receptor] T cell approvals, there's so much more work to do in these labs. Every time you bring in a new research protocol, you’ve just created a huge project for somebody in the lab, and the staff have to be trained in the new protocol,” said Ward.

Right Out of School

Finding new grads with the right skills is a challenge as well. “Initially, a lot of people from the blood banking field moved into cell therapy,” said Ward. This made good sense. Blood bank staff are already trained in basic laboratory skills, sterile environments, product management and quality. “When I used to hire people, I would try to hire people out of the blood bank. Cell therapy is kind of an offshoot of blood banking ,” Ward said.

Laboratory scientists have also made up a large swath of biotherapy staff. “Now, I would say that more than half of the people working in these labs in the United States went through laboratory science school, like I did,” said Ward.

Others have some kind of science background. “I don't know that cell manufacturing has progressed to the point that it's requiring fundamentally new types of jobs or new types of skills. It's a lot of the same laboratory skills and unit operations involved in making other biologic medicines, like monoclonal antibodies or vaccines,” said Balchunas.

There are no specific degreed schools or formal training programs for cell therapy laboratory work. “I got a four-year degree in technology, and that set me up really well to work in cell processing labs,” said Ward. “But there are fewer medical technology/laboratory science graduates than there used to be.”

Biotherapies in general, and cellular therapies in particular, may experience an image problem that may limit the number of young people entering the profession. There are a lot of other job options out there. “So, for me to talk about medical technology and making $50,000 a year, kids are like, ‘oh no, not gonna do that,’” said Dworsky.

“CAR T cells are potentially curative for some cancers, and it’s likely that there is a lot more of that down the road. You would think it would be a lot easier of a sell. But I think our industry has always been plagued by not being seen as sexy and exciting,” said Balchunas.

The double whammy is that, not only is there a shortage of young people going into biotherapy work, but another generation is also reaching retirement age. This raises the question of who will replace the employees with 30 years of knowledge when they retire.

It’s a Multi-Disciplinary World

The expanding world of biotechnology requires more than just individuals with lab skills, too. “Automation and digitization initiatives have taken off in our industry. It's created a need for more critical thinking skills,” said Balchunas. “The industry is becoming increasingly multidisciplinary. They don't just need microbiology, chemistry, and biochemistry majors. They need statisticians, data scientists, computer scientists and communicators. They need people from all these different disciplines to be aware that there are jobs for them in biopharma.”

Ward agreed. “You're talking about multiple disciplines. You're talking about programmers and data analysts. And those people have much better paying options out there.”

Moving Forward

Part of the solution is better aligned education, better outreach earlier in that pipeline and  leveraging local resources. “I think there's a huge, recognized need within the education community to look at how we can have degree programs that are more applied in nature, so that they're cranking out graduates who can hit the ground running,” said Balchunas.

“The important thing is that [businesses and labs] recognize that there is there is a need to innovate around the models that they're using for hiring and at least reevaluate the need for a bachelor's degree in all roles. I think there's a critical need to kind of think more innovatively about who is being hired to do what job and why,” Balchunas said.

Getting Local

“Biotherapy companies and cell labs need to look at how to better leverage local partners,” Balchunas said. “I think there are strong academic partners, whether it's community colleges or universities in many regions with growing cell therapy industries. In many cases, I think they're underutilized relationships.”

Many startups, for example, have strong connections with local infrastructure, according to Balchunas. “Just speaking from my own experience in North Carolina, I know that a lot of the  small and growing companies are very plugged into the applied degree programs and training options within the local infrastructure. They get their names out there locally.”

Dworsky agreed. “One of the things that I think that some organizations probably do better than others is to engage with local educational institutions, whether it's community colleges, four-year colleges, universities, whatever,” she said. “You have to be part of that environment so that you can speak to the opportunities for young people that are getting degrees in biology or chemistry.”

There’s also a role for professional organizations, like AABB, to create and promote recruiting materials and events, said Ward, who participates in two AABB cellular therapy subsections. In fact, these subsection members are grappling with steps that AABB can take to fill in the short-term gaps and encourage more young people to move into biotherapies. Balchunas said, “I get the sense just from the companies that I've talked to that the people are starting to think strategically about how to better source talent from a policy level.”

“Now that we have the talent acquisition leadership, the recruiters from companies and career services and faculty from academic institutions at the table, the question is how we can help nurture things? How can we help innovate that whole sourcing process to help students connect to jobs and opportunities a little bit better?” Balchunas said.

Organizations like NIIMBL have a role to play, as well. “We recently piloted a national job fair,” said Balchunas. “Over the course of the 3-day event, 600 students from 120 different academic institutions across the country met with recruiters from 35 companies in nearly 2,000 meetings. The focus was both internships and co-ops, as well as entry level jobs.”

Looking Abroad

In the short-term, the solution may come from abroad. “With the kind of labor shortage that I have heard mentioned… there's a lot of people outside of [the U.S.] who could fill some of these roles,” said Balchunas. Companies and other organizations may have to look outside of the U.S. right now for people who are interested in these kinds of opportunities.

The view expressed in this article are those of the speakers and do not represent the position of their employers.