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Training the biomanufacturing workforce.

Article Excerpt
The biotechnology industry has been experiencing personnel shortages in biomanufacturing for over a decade. Surprisingly, neither academia nor the industry has been willing to take the lead in training initiatives to combat these shortages. This article discusses the genesis and scope of biomanufacturing labour shortages, the types of training programmes available, and how to avoid these shortages from reoccurring.

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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)

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...

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