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Academia's Response to the Growing Biopharma's Workforce Needs

Kamal Rashid & Bart Weimer

The biopharmaceutical industry (Biopharma) has provided great opportunities for economic development and has been an important contributor to high technology industries around the world. Workforce development is invaluable for this industry because continued economic success requires a highly trained workforce. Integrated degree programs that provide graduates with combined experience in biological science, biochemical engineering, computer science, and information management can provide a more knowledgeable workforce suited to the needs of industry. College graduates who need retooled skills to meet the scientific and business demands of the industry need task-oriented training to remain current with new tools and techniques. Retraining offers employees in biopharma a short time (about one week) away from their jobs to acquire new information and skills to further their careers. Rapidly advancing scientific and information management methods create a need for continuing workforce education and task-oriented training so employees could maintain competitive skill sets.

Academic institutions have extensive expertise educating students in specific disciplines through teaching fundamental concepts of a process or reaction. Once a graduate arrives in a job, however, it is inevitable that he or she will need additional task-oriented training in specific aspects of processes and reactions not covered in their university degree program. As a person progresses to new jobs or tasks, additional expertise and knowledge are also needed. This demands retraining in specific technical areas.

The US Department of Labor identifies important workforce issues in the biotechnology sector as recruitment, basic education, and task-oriented training ( 1 ). The combined biotechnology and pharmaceutical industry is expected to be one of the top 10 fastest growing industries by 2012, with a projected growth of 70%, which compounds these human resource demands ( 2 ). At least 40 U.S. states have expanding life science industries and all 50 states have biotechnology or systems biology development initiatives. A study commissioned by the Biotechnology Industry Organization (BIO) found that states are also interested in expanding biotechnology education to support this rapid growth during the next decade ( 3 ). Both BIO and the Department of Labor noted that a shortage of well-trained personnel will limit growth of the biotechnology industry. It is critical that industry partner with academia to provide task-specific training opportunities and to meet the increasing workforce needs.

It is projected that the industry revenue will quadruple in 10 years (reaching $33.6 billion by 2015), which has states betting on investment in the biotechnology industry to bolster their economies. The anticipated benefits include high-paying jobs and economic opportunities for states in desperate need of economic revitalization. One source of funds for local economies comes from research and development expenditures which amounted to $20.5 billion in 2002 and are expected to increase by 10% in the United States during the next decade ( 3 ). This amount of expansion is expected to increase jobs by 13% by 2007 ( 1 ). Such growth can be successful only with an adequate number of motivated and highly qualified employees. Thus, workforce training must also increase to keep pace with these commercial demands. Specific challenges to industry include finding experienced technicians with specialty skills that align with a highly regulated work environment, such as cGMPs, validation, quality control, and regulatory requirements. It is difficult to find adequately trained candidates to fill current needs, let alone enough applicants to meet the almost doubled needs of the next decade. Providing education and task-oriented training for a rapidly expanding industry is a challenge for educational institutions, especially in the face of shrinking state budgets and decreased funding for higher education.

Recruitment is especially challenging when an employee's knowledge base must include regulatory knowledge plus scientific knowledge that is often customized to unique processes for individual biotechnology companies. That environment creates a demand for nontraditional training programs with high-quality content. This content must be relevant to the workforce of today and can satisfy the industry's requirements for tomorrow. It also calls for academia to help train future graduates to meet the needs of this dynamic industry for the benefit their states' economic futures. In an effort to meet the increasingly demanding workforce needs of the biotechnology industry, the US Department of Labor's Employment and Training Administration is conducting forums with targeted high-growth industries ( 4 ). These forums are opportunities for industry leaders and personnel managers, educators, public and private workforce professionals, and economic development organizations to create a unified vision so these diverse groups can work together to identify solutions that address workforce needs. The biopharma industry will benefit from employee training focused on hands-on experiences in the life sciences and the skills needed to handle information management and regulatory issues specifically related to biotechnology-based production.

One part of answering the industry's needs is task-oriented training for existing employees. Many long-time industry employees also need training in areas that have changed significantly since they received their degrees [it would be good to give an example here, something simple which non-scientists could understand]. For example the instrumentations that are utilized in DNA analysis, protein characterization and purifications and large scale drug development are constantly changing with upgrades and computer controls even from year to year. It allows the employee base to actively participate in the sector's expanding success, and provides individuals with a sense of ownership. It also creates satisfaction among employees, leading to a stable and happy workforce, which in turn brings companies continuity of process knowledge and, ultimately, a higher quality product.

Colleges and universities produce many graduates with bachelors, masters and doctoral degrees in life sciences and engineering. Often, however, these graduates are not adequately prepared with the proper skills for entry-level positions. They usually lack specific laboratory skills and job-related experience that are critical to the successful manufacture of a product. Many science graduates thus enter the biotechnology and biopharmaceutical job market still in need of training.

Workforce retraining allows employees to expand their knowledge of biotechnology and bioprocessing in areas directed by the needs of the company and industry. New graduates who lack training in specific areas (e.g., industrial-scale fermentation and cell culture),find retraining programs to be perfect crash-courses that allow them to become proficient in the key elements of a topic within a few days. Retraining courses can also be useful as employees advance their careers and need new skills. The different stages of biologics production act as a template for the skills needed in a qualified and well-trained technician. Optimizing an employee's skills leads to smooth operation during development and production. The areas needed for training are cell line preparation and characterization, media optimization and sterilization, reactor design and operation, process optimization, and a working knowledge of process parameters (such as pH, temperature, and dissolved oxygen control) at pilot and industrial scale operations. Training courses can provide hands-on experience with methods and tools to prevent contamination during media filtration and other additions to the reactor. Once a product is in the bioreactor, skilled personnel are needed to separate and purify the desired product (usually a protein) from the mass of other cellular products to meet regulatory agencies' purification qualifications. Thus, several steps including large-scale cell disruption, centrifugation, micro- and ultrafiltration, and process chromatography are necessary to achieve a pure final product. In each phase of production, unique skills are required that may not have been covered during a formal education. Additionally, steps unique to large scale processing are more appropriately covered in workforce training programs.

Many of the hands-on practical techniques involved in biopharmaceutical production processes are not taught in classical biochemistry, microbiology, or molecular biology classes in the traditional academic environment. Universities, as teaching institutions, must extend themselves and link with the biotechnology industry and state and federal agencies to create a well-trained workforce. Close cooperation between universities and industry can successfully address the industry's need for the development of programs to fill knowledge gaps in entry-level personnel. Training programs developed by academic institutions can strengthen the industry's employee base and lead to economic growth and increased profitability by providing increases in graduates' working knowledge of technical and regulatory specifics. The regulatory aspects of the biotechnology industry are not a focus in most university courses, but it is a critical and demanding part of this industry. Strategic training partnerships between universities and industry are necessary to produce the intellectual and physical resources necessary for the industry's success.

Training and periodic retraining of the bioprocess-related workforce will keep businesses technically viable for production and current with regulatory processes. Industry needs strong programs delivered by highly trained instructors and designed to meet its needs for expanded growth. Structured training programs that focus on market needs are more adaptable in their offerings for the technology-based requirements of biotechnology than traditional university-based degree programs. For example, the number of industry products is expanding with advances in the areas of genomics and proteomics. Production in those areas is expected to accelerate in the next 10 years. With this expansion comes the need for a workforce that understands and uses bioinformatics to decrease production costs while delivering quality products. With new uses of bioinformatics comes the need for a fundamental understanding of advanced statistical tools new to biotechnology. Traditional academic institutions are not producing graduates with the diverse set of technological skills necessary for biomanufacturing — the merger of life science, engineering, bioinformatics, and statistics.

Several universities and colleges have realized this need and are developing training programs to fit the needs of industry. For example, Utah State University ' (USU) Center for Integrated BioSystems has several short, intensive, hands-on training course offerings. These course offerings provide biotechnology employees with the hands-on laboratory skills and latest theoretical background they need in today's market. The courses emphasize training in advanced manufacturing and research methods along with practical experience. In many cases, leading-edge equipment manufacturers are among the course instructors to ensure that participants learn the latest techniques while handling the most modern equipment. Pilot-scale capabilities and experiments are part of the training courses.

These short but intense training courses have earned an international reputation, in part because of partnerships established over the years with biotechnology and biopharmaceutical companies, such as New Brunswick Scientific Company, Inc., GE Healthcare, HyClone Laboratories, Applikon, Sartorious, Broadley James Corporation, Prolexys, Affymetrix, Invitrogen , Cornings and others. These partnerships were established to allow program participants to network with equipment manufacturers and material supply companies. Some of the unique characteristics of USU's biotechnology and bioprocess training programs include:

• emphasis on hands-on laboratory work using the latest techniques and instrumentation from bench- to pilot-scale,

• small classes that allow individualized instruction and informal discussions,

• informal discussions and networking among participants and instructors,

• most important, the availability of highly skilled instructors from both academia and industry to respond to the needs of program participants.

Taken together, these form a training program that provides maximum benefit to both the employee and the company.

From the industry's point of view, training programs at leading universities are affordable and efficient vehicles for employees to learn about new topics using state-of the-art equipment and the latest technologies. They also present important opportunities for industry participants to network with their counterparts in equipment companies and with professors who might be of help in solving unusual problems during processing. Technologies are rapidly changing, and in many cases equipment required for training is too costly for academia to bear alone. Collaborations often provide academia access to cutting-edge manufacturing equipment and manufacturers with a critical testing ground for equipment improvements. Innovations in the biotechnology industry demand a workforce with strong and constantly growing skill sets. Savvy academic institutions know they can fill a need for the biotechnology industry by providing new graduates with hands-on skills and follow-up workforce training. When industry provides cutting-edge laboratory resources and academia provides the teaching, hands-on training is affordably accessible for the rapidly growing population of bioprocessing professionals.

REFERENCES

1. US Department of Labor. News Release. US Department of Labor Hosts Biotechnology Industry Executive Forum in Newark , Delaware . May 2003, www.dol. gov/opa/media/press/eta/ETA2003255. htm.

2. US Bureau of Labor Statistics. 2004 05 Career Guide to Industries , www.bls.gov/oco/cg.

3. Biotechnology Industry Organization. The Editor's and Reporter's

Guide to Biotechnology, www.bio.org/ speeches/pubs/er/BiotechGuide.pdf.

4. US Department of Labor's Employment and Training Administration.

Workforce Issues 2004, www.doleta.gov/ ,BRG/IndProf/BioWI.cfm.

For more information visit: www.biosystems.usu.edu

For more information about The Center for Integrated Biosystem's Biotechnology and Bioprocessing training programs please see the following web site:

http://www.biosystems.usu.edu/education/industry_training/

For Glossary of Terms in this article: Developing the Workforce: Glossary