Training the Biomanufacturing Workforce

Over the past 25 years, the biotechnology industry has transformed itself into one of the fastest growing and most vibrant sectors of the global economy. Although the US is still the world leader in biotechnology, many other countries have developed their own biotechnology industries.

There are around 4000 biotechnology companies worldwide that employ more than 200000 people.^1,2 Recent reports indicate that an additional 286000 jobs are found at companies that provide goods and services to the biotech industry.³ Industry analysts predict that the biotechnology industry will continue to expand well into the 21st century.

Historically, biotechnology companies have focussed almost exclusively on drug discovery and development activities. However, during the past few years, the focus at many biotechnology companies has shifted from drug discovery and development to bioprocess development and commercial manufacturing. This shift has been fuelled by large increases in the number of biotechnology companies that are either seeking or have gained marketing approval for their products.

At present, there are as many as 1200 biotechnology products in the global pipeline.^1–3 Although this would seem to be good news for the biotechnology industry, worldwide shortages of biomanufacturing personnel now threaten many biotechnology companies' ability to manufacture sufficient amounts of their products to meet market demand.

Where the jobs are

Industry analysts estimate that job growth in biomanufacturing has averaged about 10% a year since 1990.^1,4 This annual growth rate is expected to continue during the next decade. A quick perusal of the job opportunities at many biotechnology companies, contract manufacturing organizations and staffing/recruiting websites reveals that biomanufacturing jobs are plentiful.

The degree requirements for these jobs range from a high school diploma to a PhD degree, with the majority of positions being filled by individuals with either associate or bachelor degrees.^5,6

Table 1. Job types and degree requirements for bioprocess and biomanufacturing jobs.

A recent report issued by Boston-based Education Development Center Inc. indicated that the majority of new biomanufacturing jobs will be for technical personnel in the following areas:⁷

• quality control (QC) chemistry

• QC microbiology

• environmental health and safety

• facilities maintenance

• instrumentation/calibration

• manufacturing (upstream)

• manufacturing (downstream)

• process development

• quality assurance (QA) documentation

• validation

• aseptic processing (fill/finish).

The functions and degree requirements for each of these positions is shown in Table 1.

Why are there staffing shortages?

Biomanufacturing staffing shortages first appeared in California and the northeastern part of the US during the late 1990s.^5,8 This was largely a result of increases in regulatory approvals for new biopharmaceutical drugs and an unprecedented demand for products manufactured by biotechnology giants such as Amgen, Genentech and Biogen (now, Biogen/IDEC). Although the demand for biomanufacturing employees in the US levelled off from 2001 to 2003, it is rising rapidly again.⁷

Interestingly, biomanufacturing staffing shortages have also begun to appear in Europe and Asia. This is because of the rapid emergence of global contract biomanufacturing organizations (CBMOs) in these regions and the growth of indigenous national biotechnology industries.

Unfortunately, similar to the late 1990s, the number of vacant biomanufacturing jobs currently exceeds the number of qualified employees to fill them.

A 2004 survey conducted by BioPlan Associates, indicated that more than half of the biomanufacturing managers who were surveyed thought that the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.⁷

There are a variety of factors that have contributed to current global biomanufacturing staffing shortages. First, as previously mentioned, there has been a sharp increase in the number of companies that have drugs in clinical development or have received marketing approval for their products. To keep pace with increasing biomanufacturing demands, many CBMOs and several large biotechnology companies have either expanded their existing facilities or built new ones.⁷ Unsurprisingly, this recent industry-wide expansion sparked a hiring increase, which, in turn, placed an enormous burden on an already small pool of prospective biomanufacturing job candidates.

Second, biomanufacturing is a complex, labour-intensive process that requires unique skills and specialized training.

Biomanufacturing employees are not only required to have a firm grasp of the scientific underpinnings of biotechnology, they must also learn how to operate specialized equipment and work in manufacturing environments that are tightly regulated by current good manufacturing practices (cGMPs).

Although many community colleges, technical schools and universities have recently created biotechnology training programmes, most concentrate on drug discovery and development, and pay little attention to biomanufacturing or cGMP training.⁵

This is not surprising because many of these programmes were developed by academic scientists who typically lack industry experience and are unaware of the regulations or industrial skill sets that are required by biomanufacturing employees.

Consequently, whereas many biotechnology programme graduates may be qualified for R&D jobs, they typically lack the requisite understanding and skills to be employed in biomanufacturing jobs.

Finally, and perhaps most importantly, neither industry nor academia is willing to assume a leadership role in biomanufacturing workforce development training.

Despite repeated labour shortages, the biotechnology industry, with few exceptions, has been reluctant to provide financial or institutional support for biotechnology workforce training initiatives. This is probably because of a belief held by many biotechnology executives and industry insiders that workforce development training should be the responsibility of academia, not industry.

However, academic leaders acknowledge that more biomanufacturing training is necessary, but claim that their institutions cannot develop biomanufacturing training programmes because of high costs, lack of available space and a paucity of adequately trained instructors.

In an effort to overcome this 'training stalemate', several governments, most notably the US, Ireland and Scotland have allocated substantial amounts of government funding for biomanufacturing workforce training.^9–11 For example, in 2004, the US Department of Labor launched a $17.2 million nationwide biotechnology worker development training initiative.⁹ Nevertheless, biomanufacturing labour shortages will continue until academia and industry can agree upon who is responsible for training a biomanufacturing workforce.

What is being done?

At present, there is little agreement on how to deal with shortages of trained biomanufacturing personnel. Some industry experts believe that the problem will resolve itself through competitive free-market pressures whereas others feel that direct corporate involvement will be required.

Over the past 2 years, a variety of training initiatives have been launched to deal with biomanufacturing staffing shortages. These initiatives typically fall into three distinct categories:

• academically-initiated training

• government-sponsored training

• industry–academic partnerships.

The UK is currently the European leader in academically-driven biomanufacturing training and workforce development programmes. An outstanding example of this is The Scottish Colleges Biotechnology Consortium (SCBC). The SCBC is a four-college initiative that created a Bioprocess Workforce Development Programme to train bioprocessing and biomanufacturing technicians.¹²

This programme offers students or company employees hands-on, competency-based training. In addition, the SCBC recently crafted several e-learning training modules that can be used to complement its 'bricks and mortar' courses. These online courses were launched in 2003 and are currently available to the public on the SCBC website (www.scottishbiotech.org).

Other UK training programmes that deserve mention are the Masters degree in Biopharmaceutical Processing at the University of London and the MSc degree in Biochemical Engineering at the University of Birmingham. Finally, the University of Edinburgh committed £100 million towards the creation of a biomanufacturing facility that will offer hands-on training and has sufficient space to house 10 biotechnology companies.

Table 2. Community colleges and universities that offer bioprocess development and biomanufacturing training.

This will be Scotland's first dedicated biomanufacturing facility and it will create about 900 jobs when it is completed in the next few years.¹⁰

In the US, academically-initiated biomanufacturing training has been largely championed by 2-year community colleges and technical schools.^5,6,8,12 The US reliance on community colleges and technical schools to provide biomanufacturing training is consistent with the stated missions of these institutions, which are to provide technical training to individuals who want to join the American workforce. To that end, a number of community colleges (and a few 4-year institutions) in biotechnology-rich regions such as California, New England, Maryland and North Carolina currently offer hands-on biomanufacturing training to students in cGMP simulated environments (Table 2).^5,6,8

When possible, many of these programmes use local biotechnology company employees as instructors to insure that students are receiving industry-appropriate training. Students or company employees enrolled in these programmes receive either a biomanufacturing certificate degree (after 1 year) or an associate's degree upon completion of 2 years of training.

Many of these programmes also offer short courses and workshops (that are open to the public) on various bioprocess development and biomanufacturing topics.^4,5,8

Typically, graduates of these biomanufacturing programmes find jobs at local biotechnology companies upon completion of their training.

As previously mentioned, a number of government-sponsored biomanufacturing training and workforce development initiatives have been launched in Europe and the US. The British government recently funded a project to build the National Biomanufacturing Centre in Liverpool (UK), which will serve as a biomanufacturing and development training centre. The 4920 sq ft facility will cost about £34 million to build and it is expected to open in early 2006.¹¹

One of the largest and most ambitious of these government programmes was recently announced by the North Carolina state government.⁴ In August 2003, it committed $64.5 million towards the creation of a state-wide biomanufacturing training network. The goal of this programme is to prepare new and displaced workers for technical jobs in the bioprocess and biomanufacturing industries. One of the network participants, North Carolina State (NCS) received $36 million to build and equip a 90000 sq ft training facility that will provide hands-on experience in a commercial-scale cGMP manufacturing environment.

Another participant, North Carolina Central University, received $19.1 million to build the Biomanufacturing Research and Training Enterprise Center to create relevant undergraduate and graduate degree programmes. The remaining $9.4 million was given to the North Carolina Community College System to recruit and train workers and serve as a 'feeder system' to the programmes at NCS and NCCU.⁴ Both training facilities are expected to open by 2006.

Key points

Finally, similar, but less ambitious state-wide biomanufacturing training programmes have been funded by the Massachusetts and Rhode Island state governments.^13,14 Also, several Canadian cities, including Ottawa and Montréal, are considering developing state-sponsored biomanufacturing training programmes.¹⁵

Despite ongoing biomanufacturing labour shortages, there have been surprisingly few academic–industry training partnerships formed to deal with the problem. The reasons for this are not entirely clear.

Nevertheless, many of these partnerships have been formed in biotechnology-rich regions, including California and the northeastern US, where local biotechnology companies understand the long-term benefits of workforce development training. These types of partnerships have just begun to appear in Europe. They should increase in number as the European biotechnology industry grows and matures.

The best example of an academic–industry partnership is the Moorpark College Industrial Biotechnology Programme that was formed between Baxter Healthcare Corporation and Moorpark College (CA, USA).¹⁶ The impetus for the formation of this partnership came directly from Baxter Healthcare Corporation in response to a need to staff a new biopharmaceutical manufacturing facility that it had built near Moorpark college.

After several years of planning, college administrators, faculty members and company employees crafted an industry-focussed, hands-on biomanufacturing training programme for students and entry level corporate employees. The programme focusses on eight distinct biomanufacturing processes that include:

• cGMP and plant design

• process support

• cell culture/microbial fermentation

• recovery/purification

• formulation/fill/packaging

• QC

• environmental monitoring

• validation.

The entire programme is taught in an 8000 sq ft biomanufacturing training facility that was set up to mimic a commercial biomanufacturing plant. All the courses in the programme are taught by biotechnology company employee volunteers.

In 2003, the Rhode Island Technology Council, the Workforce Partnership of Greater Rhode Island and several Rhode Island-based biotechnology companies launched the Rhode Island Biotechnology/Biomanufacturing Training Initiative (BTI). The BTI is a 3-year, $3 million partnership designed to address critical workforce skills shortages affecting the biotechnology/biomanufacturing industries.

A similar programme, created in 2004, is a Boston-based pilot biomanufacturing worker-training initiative known as 'Best in Biotech'.¹³ It was developed by the Massachusetts Biotechnology Council (MBC) and its foundation, MassBioEd. Members of the Best in Biotech consortium include MBC-member companies, regional work force investment boards, and Massachusetts-based Roxbury and Middlesex Community Colleges.

The programme is an intensive 4-week hands-on, industry-focussed biomanufacturing training experience. The tuition for qualified students is paid by the programme and participating students also receive a modest salary during the training period. Finally, also in 2004, the Education Development Corporation Inc. of Boston, partnered with a consortium of community colleges, universities and various biotechnology companies from Maine to Virginia to form the Northeastern Biomanufacturing Collaborative (NBC).

The stated goal of the NBC is to develop and implement skill standards for technician training for biomanufacturing jobs. At present, it is not clear how much biomanufacturing training will actually be performed or offered by consortium members. Nevertheless, a number of high-profile biotechnology companies including Amgen, Biogen/IDEC, Genzyme, Millennium and others are part of the NBC network.

What must be done?

Although many of the above mentioned training initiatives are timely and well-intentioned, it is generally believed that they will be unable to keep pace with industry demand for trained biomanufacturing personnel.

This is likely for a number of reasons. First, many academic and government-sponsored biotechnology training programmes suffer from chronic low enrollment. To that end, these programmes simply cannot train students fast enough to meet industry demands. Second, most of these training programmes were created using funds obtained through state and federal government grants and have not developed alternative funding or financial strategies to sustain them when grant funding lapses.

Consequently, the longevity of these programmes is always questionable. Finally, and somewhat paradoxically, employment outcomes for many biotechnology training programme graduates are extremely poor. These poor outcomes are likely because a majority of these training programmes do not offer any job counselling, job preparation training or job placement services to their students.

Many in the industry believe that workforce shortages will continue to occur until the biotechnology industry, as a whole, assumes a leadership role in biomanufacturing workforce development activities. It is noteworthy that there has been a recent surge in formation of academic–industry training partnerships, perhaps signalling that the biotechnology industry is willing to finally assume a leadership role.

The academic–industry partnership training model seems to hold the most appeal for academics and biotechnology executives alike. This is likely because, according to this training model, each partner assumes its fair share of the financial burden required to develop and run the programme.

Typically, industrial partner(s) provide instructors, laboratory/manufacturing equipment, and marketing and advertising support whereas academic partner(s) usually supply classroom and laboratory space, and course development and teaching expertise. An added benefit to these types of partnerships is improved employment outcomes for programme graduates.

Employment outcomes in these partnerships are usually better because student trainees typically work closely with company employees and, as a result, have greater access to internships and jobs upon completion of their training.

An increase in the number of government-sponsored local and regional biomanufacturing training facilities, similar to the ones being built in North Carolina and the UK, should also help to combat global biomanufacturing personnel shortages.

Generally speaking, smaller companies cannot afford the time and costs required to send employees long distances for specialized training. Access to local or regional training facilities will provide these companies with time and cost-effective training solutions. Also, because these training facilities are usually located in biotechnology-rich locales, in close proximity to many colleges and universities, students who matriculate through these facilities will serve as an abundant and well-trained source of employees for local biotechnology companies.

Another possible solution to biomanufacturing staffing shortages may be the emergence and proliferation of companies that specialize in biomanufacturing training. These companies typically offer either customized corporate training or public courses on topics such as cGMP training, upstream and downstream processes and aseptic (sterile fill/finish) processing.

Recently, one of these companies partnered with a CBMO and local workforce development agencies to offer hands-on aseptic processing course to individuals seeking employment as biomanufacturing technicians.

These types of business-business-government training partnerships and alliances may represent an innovative solution to improve biomanufacturing training.

The way forward

It is evident that biomanufacturing labour shortages are one of the most critical and pressing issues facing the biotechnology industry today.

Without an adequately trained workforce, the biotechnology industry will be unable to sustain its ongoing economic development and expansive growth. The time has come for academic leaders, government officials and biotechnology executives to work together to collectively develop innovative and cost-effective biomanufacturing training solutions.

Without this type of cooperation between academia, government and industry, it is likely that the biomanufacturing workforce shortages that have plagued biotechnology companies in recent years will continue well into the 21st century.

References

1. F. Kermani, Contract Pharma, October, 68-81 (2004).

2. Beyond Borders: The Global Biotechnology Report, (Ernst and Young, London UK, 2002).

3. www.bio.org

4. www.pharmaceutical-int.com.

5. C.S. Mintz, Bioprocess Intl. 2, 16–23 (2004).

6. http://cse.edc.org/products/biomfgskills/introduction.asp

7. www.contractpharma.com/March041.htm

8. www.ccweek.com/FeatureFull.asp

9. www.larta.org/lavox/articlelinks/2004/040823dol.asp

10. www.adsumo.com

11. www.expansionmanagement.com

12. R.C. Kennedy Thomson and J. Porter, Biochem. and Mol. Biol. Ed. 31(1), 59–61 (2003).

13. www.massbiotech2010.org/report/rolestate.html

14. http://tech-collective.org

15. www.nrc-cnrc.gc.ca/clusters/montreal-ls_f.html

16. M.T. Harrigan, Biochem. and Mol. Biol. Ed. 31(2),142–144 (2003).

Clifford Mintz is CEO of BioInsights Inc., USA.