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Introduction

The pharmaceutical and biotechnology industries--collectively known as the life sciences industry--have experienced expansive growth over the past decade. Between 1993 and 2003, more than 360 new medicines, biologics, and vaccines have been approved by the U.S. Food and Drug Administration (FDA) to treat more than 150 diseases and medical conditions.

Not surprisingly, the size of the life sciences workforce has also grown dramatically over this period. A 2004 report by the Pharmaceutical Research and Manufacturers of America estimates that American pharmaceutical companies employ more than 75,000 people in the areas of R&D, clinical development, and legal and regulatory affairs. Recent surveys show that American biotechnology companies employ approximately 191,000 people in high-value jobs. Further, both reports indicated that an additional 286,000 jobs were generated by companies that provide goods and services to the biotechnology industry. Despite some recent industry consolidation, the pharmaceutical and biotechnology industries are poised for continued growth and represent good employment options for scientific and medical personnel.

Industrial Job Opportunities

Drug development and commercialization is an inherently complex and labor-intensive process. Typically, it takes anywhere from 12 to 19 years to develop a drug, gain regulatory approval, and bring a successful product to market. Employment opportunities exist at every step of the drug-development process (Table 1).

 

DISCOVERY

DEVELOPMENT: Preclinical

DEVELOPMENT: Clinical

MANUFACTURING

Molecular Biologists

Pharmacologists

Clinical Research Associates

Sterile Fill Personnel Pharmaceutical Operators

Biochemists

Toxicologists

Clinical Data Managers

Quality-Control Specialists

Medicinal Chemists

Process Chemists

Drug Safety Personnel

Quality-Assurance Specialists

Computational Chemists

Analytical Chemists

Nurses

Regulatory Affairs Personnel

Biophysicists

Bioreactor Scientists

Physicians

Current Good Manufacturing Processes (cGMP) Technicians

Bioinformatics and Genomics Scientists

Regulatory Affairs Personnel

Statisticians

Validation Specialists

Biomedical Engineers

Veterinary Personnel

Clinical Operations Personnel

Bioprocess Scientists

Data Managers

Biomedical Engineers

Pharmacologists

Analytical Chemists

Automation and Robotics Scientists

Formulation Scientists

Regulatory Affairs Personnel

Marketing Personnel

Table 1. Job Opportunities in the Drug-Development Process

Over the past 15 years, there has been a noticeable shift in these industries away from drug discovery toward drug development and commercial manufacturing. This shift in emphasis has created jobs in analytical chemistry, pharmacology, toxicology, regulatory affairs, bioprocess and process developments, validation, quality control, quality assurance, clinical trials management, and large-scale manufacturing. This shift has also resulted in a decreased demand for science Ph.D.s--who are highly sought in drug discovery--and an increased demand for baccalaureate- and master's-level scientists to fill jobs in quality systems, regulatory affairs, clinical trials management, and manufacturing.

Academic Training and Industry Job Requirements

Despite the growing number of job opportunities in the life sciences industry, it is increasingly difficult for undergraduate and graduate students to secure entry-level jobs at biotechnology and pharmaceutical companies. Although this trend is troubling and seems, at first glance, paradoxical, there are explanations.

Many students lack the appropriate training and qualifications for entry-level jobs at pharmaceutical and biotechnology companies. Unfortunately, most undergraduate and graduate programs do not offer training in drug development, quality systems, and manufacturing. This is likely due to 1) lack of well-informed and qualified faculty members to initiate and develop specialized curricula on these topics and 2) a belief that job training is the responsibility of prospective employers, not academic researchers. Unless substantive curricular change is made to existing academic programs, the road to employment for many students will continue to be bumpy and fraught with difficulty.

In contrast to academic research, industrial research is highly regulated and guided by legally enforceable rules and regulations, e.g., Current Good Laboratory Practices (cGLP), Current Good Clinical Practices (cGCP), and Current Good Manufacturing Practices (cGMP). These rules and guidelines were created by regulatory agencies such as FDA to ensure the development of safe and efficacious products. In recent years, FDA has begun to enforce these rules and regulations more strictly. As a result, many life sciences companies now require that prospective employees understand cGLP, cGCP, and cGMP guidelines and how to apply them in industrial laboratory settings. Because these rules and regulations are specific to industry and relatively unknown in academia, most academically trained job candidates fail to qualify for these industrial jobs.

Finally, over the past 5 years, there has been a growing emphasis on the importance of so-called soft skills, e.g., good oral, written, and communication skills; teamwork; and professional behavior, in existing and prospective employees. These skills are increasingly important as life sciences companies grow larger, more diverse, and increasingly multidisciplinary in their approach to drug discovery and development. Unfortunately, few academic programs develop these skills in a systematic way; this failure hinders students from landing industrial jobs.

Transitioning From Academia to Industry

Although the transition from academia to industry can be difficult, students can take several steps to improve their odds. First, take advantage of available resources in preparing your résumé and learning how to interview for an industrial position. A well-written, carefully crafted résumé can result in an interview, and a professional interviewing style can increase the likelihood of a job offer. Working with a skilled and well-connected professional recruiter may also increase the probability of securing an industrial job. Second, many community colleges and several companies now offer specialized training in quality systems, regulatory affairs (cGLP, cGMP, and cGCP), and other areas. Finally, there is no better way to get an industrial job than to have previous industrial experience. To get industrial experience, seek out training opportunities that include an industry internship as part of the curriculum. Some biotech and pharmaceutical companies may offer volunteer opportunities, and many have postdoctoral positions.

Conclusions

Universities that are interested in placing their science graduates in industrial positions need to add appropriate applied courses to their curricula in areas such as quality systems, regulatory affairs (cGLP, cGMP, and cGCP), and manufacturing. Other training opportunities, in technical writing, public speaking, résumé preparation, and interviewing skills, should also be added to hone the soft skills of graduates. Finally, students need to be made more aware of the job opportunities available to them in the private sector, which can be accomplished through university-sponsored job fairs, guest lecturers from the life sciences industry, and visits to local biotechnology and pharmaceutical companies. If all of these challenges can be met, the transition for students from academia to industry will undoubtedly be easier in the future.

Cliff Mintz is founder of BioCrowd, a new social networking site for bioprofessionals.