Biotech Training is a Challenge

Biotech Training is a Challenge

June 11, 2024PAO-06-24-NI-01

One of the ongoing challenges in the biomanufacturing industry is an ongoing labor shortage. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public–private partnership that was founded in 2017 to study, highlight, and address the challenges in the industry.1 In 2022, they published a study in which they surveyed manufacturers across the United States and found the talent shortage to be ubiquitous.2 While the shortage is felt across all levels of biomanufacturing organizations, it is striking that only 42% of job postings for manufacturing associates required a bachelor’s degree.2 Traditionally, firms across industries will pay relocation fees for high-level employees, such as managers and above, but relocation support for entry-level employees without a college degree is rare. Companies are left, then, to recruit from local talent for entry-level manufacturing associates jobs while they simultaneously compete nationally (or even globally) for more educated talent.

When companies do hire talent, new employees with a college degree often haven’t been trained in the practical aspects of operating biomanufacturing and supporting analytical equipment, and even fewer are familiar with the basic concepts of GMP manufacturing, the structure and function of cleanrooms, and GMP documentation. NIIMBL reported that nearly 20% of survey respondents rated it “very difficult” to hire for QA/QC positions, and 12% rated it “very difficult” to hire manufacturing and production positions. New employees at all levels, therefore, often need to undergo extensive training before they are self-sufficient in their roles. Such training can often take up to nine months, during which time the company absorbs the cost of the new employee payroll and the cost for time of the trainers and incurs the risk of having new or partially trained personnel work on ‘live’ projects, even under supervision. In an ideal program, the personnel who are training new employees would themselves undergo a train-the-trainer program, which incurs additional cost to the employer.

As if these hurdles aren’t daunting enough, employers have a difficult time retaining the employees they spent so much time training. Because of the widespread shortage, all firms are looking to hire talent, and the preferred hires are those who have some experience in the industry. Even as biomanufacturing firms continue to announce capacity expansions that are feeding a 25% increase in employment, there are not enough new workers entering the workforce to keep up. Industry experts therefore expect the labor shortage to get much worse before it improves. The recent layoffs due to large pharma restructuring programs can temporarily alleviate these pain points, but it is certain to be a short-term respite in a very long uphill climb.

So where will new talent come from? The obvious place to look for the answer is in the academic field. There are, in fact, approximately 100 colleges across 40 states that offer a two-year degree program in biotechnology,3 in addition to the various four-year degrees in life sciences or chemistry offered by most universities. These programs, however, are having trouble filling the gap. In addition to the ever-increasing cost of college, graduates aren’t necessarily trained to do the job on day one of employment. A 2022 report by Harvard Business School found that only 25% of employers (across all industries) felt they were transparent in communicating their needs to educators.4

Even where the programs exist, they aren’t necessarily full. The average citizen is familiar with the roles of an electrician, policeman, plumber, or nurse, but few have any real understanding how medicines are made, and most would be shocked to realize they could work in the field of biomanufacturing without a college degree. Jobs in the field typically pay above the median for the corresponding degree in their area and are generically cleaner and safer than the jobs listed above. When working in a cleanroom, one would never encounter a closet containing dirt and spiders, never need to argue with a drunk person, and never encounter human feces.

Despite the attractive possibilities, the general lack of awareness keeps enrollment relatively low. This is a particular challenge because, while most hands-on courses are expensive, biotechnology training is particularly expensive. Not only must the student have access to expensive equipment, but the reagents, such as media and resins, for each lesson are also much more expensive than an average chemistry or biology class. Often, the labs must be set up in specialized areas to keep the procedures sterile, which adds additional cost of building and maintaining the facility. In one example, Oklahoma City Community College (OCCC) had to suspend their hands-on two-year biotechnology program in 2017 due to low enrollment, even though nearly every graduate was hired at one of the local biomanufacturing firms. An average of six students per semester was not enough to maintain the cost of the program.

Nevertheless, biotechnology training programs are an interesting source of innovation in their own right, both in terms of curriculum and funding. Two examples highlight diversity in how these programs are designed and implemented.

Shoreline Community College in Seattle, Washington, has an internship program in which students apply to the local Big Pharma companies Bristol-Myers Squibb and Seagen (now Pfizer.) The industrial firms choose candidates, and those accepted go through a 10-week training program for which the tuition (about $1,400) is paid by the firm. Graduates are then hired for a paid internship for 10–12 weeks, where they earn about 25% above the minimum wage for the area. The program consists of four courses, which cover regulatory affairs, aseptic technique, QA/QC (quality assurance and quality control) concepts, understanding of cleanrooms, and the basics of operating a bioreactor. The eight credit hour curriculum was designed by the industrial collaborators based on their specific needs. Students who do not wish to do the internship can pay their own tuition and take the certificate to further their career wherever they wish.

Students are typically adults who wish to retrain for a new skill, such as parents re-entering the workforce, international students who have a work visa but have had trouble obtaining a job, veterans, or people recently laid off from one of the large local employers. Shoreline also has a program in which high school students can earn dual credit that will either count toward a four-year degree or fast-track them to an entry-level job upon graduation.

The Shoreline program was founded in 2021 and has seen enough success that they are already expanding. In May 2024, they announced the grand opening of a new STEM (science, technology, engineering, and mathematics) building that houses biomanufacturing labs, complete with airlocks for students to practice gowning in.

Another innovative example can be found in the Biomanufacturing Training Center (BioTC) Oklahoma program located in Oklahoma City’s Innovation District. Founded in 2021 after a $35 million award from the U.S. Economic Development Administration (EDA), the program intends to partner with local high schools, local career technical schools, community colleges and universities to provide stackable, practical training for all levels of biotech roles. The entry-level programs are concurrent with high school and demonstrate basic lab skills, such as pipetting and bench-scale equipment. The next level up is an intensive, bootcamp-style program consisting of less than 120 hours of classroom work in which students spend nearly all their time learning the basics of operating production equipment, cleanroom function, and GMP batch record concepts. They perform hands-on, skills-based operations, such as cell thaw, shake flask culturing of cells, inoculation of bioreactors, bioreactor harvest, running ion-exchange chromatography, and filtration steps. While many of the training activities are performed at bench-scale, the funding that BioTC received affords them the ability to also deliver training activities utilizing many of the same production-scale pieces of equipment found in biologics GMP production facilities throughout the United States. Additional instruction is stackable and intended for students who wish to continue focusing on their training or can be paid for by firms who send employees to the short programs (Industry Certifications) for intensive training on skills they need most in their facilities.

No matter the curriculum, location, school, or firm, the underlying issue is a lack of awareness that these jobs in biotech and pharma exist and that many of the most critical entry-level positions do not require four-year degrees. Popular conception of scientists is often in a hospital setting or a Ph.D. that feels out of reach for the young people entering the workforce or older workers who have borne the brunt downsizing in a different industry.

References

  1. About NIIMBL.” National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Accessed 22 May 2024. 
  2. Balchunas, John et al. “Innovation of the Biopharmaceutical Manufacturing Talent Pipeline.” National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). n.d.
  3. Balchunas, John et al. “Innovation of the Biopharmaceutical Manufacturing Talent Pipeline: Part II.” National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). n.d.
  4. The Partnership Imperative: Community Colleges, Employers, and America’s Chronic Skills Gap. Harvard Business School. 12 Dec. 2022.
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