The biotechnology industry is still in its adolescence, but it is about to have a major impact on health care. A third of drugs in phase III clinical trials are proteins.
Yet biologists are used to making proteins in tiny amounts for research purposes, not vats of it for a new product launch. Biotech companies are gearing up to manufacture product, but they face a shortage of talent, as most young scientists interested in biotechnology have congregated to research. ?Biopharmaceutical companies are pushing their existing staff to the limits to meet [demand],? says Cliff Mintz, CEO of the training and staff search firm BioInsights Inc. in East Windsor, New Jersey.
Biotech manufacturing means jobs, maybe
And that means job opportunities. Manufacturing encompasses a wide array of jobs: operations management, quality control, site supervision, manufacturing process engineering, and even materials procurement.
But even though the need is there, biomanufacturing can be tricky to enter for an established scientist. Says Mintz: ?This is a serious Catch-22, because if you don't have industrial experience, you cannot get a job. But who is going to give you a shot at getting industrial experience if you ... do not have the requisite skills or previous experience??
Getting the experience--not to mention the skills--is difficult because academic programs don?t view applied science as worthy of graduate programs, says Mintz. ?The irony is stark. ... Ph.D.s and postdocs are being trained in areas in which there are no jobs, and are being steered away from jobs where there is availability.?
But despite impressions to the contrary, it is not a field devoid of research. Unlike more established industries, biomanufacturing requires constant fine-tuning and occasional reinvention of manufacturing processes. Other research-related areas are bioprocess control, new expression systems for recombinant proteins, new downstream-purification methods, and upstream improvements in cell culture maintenance and levels of expression, according to Mintz.
A new generics industry may also contribute to the job market. The Food and Drug Administration is contemplating whether to allow generic versions of protein therapeutics. A few protein therapeutics have come off patent or are about to, and generics manufacturers are eager to produce cheaper versions, as has been done with generic pharmaceuticals. Protein manufacture is trickier, however, because the organisms that produce them leave their fingerprints on proteins, in the form of carbohydrate surface residues or posttranslational modifications. These bring slight chemical changes, which have the potential to change the function of a protein or lead to problematic immune reactions in patients.
These questions mean work for biomanufacturing specialists as they seek to demonstrate the feasibility of producing ?bioequivalent? versions of existing proteins--generics that may differ slightly in composition but maintain the therapeutic qualities of the original.
Biomanufacturing isn?t just churning out proteins from fermentation vats. The field is growing in new directions, including the use of genetically engineered crops or other plants to produce biomaterials. Milk from genetically engineered animals is another potential source. Significant research will go into how to set up and maintain such systems, as well as how to isolate large quantities of product.
?It?s still a hybrid between needing strong researchers and competent operators,? says Michael Kamarck, senior vice president of Wyeth BioPharma in Madison, New Jersey. That?s not necessarily an easy combination to find. ?You want people to come in and realize that the nature of the environment is following standard operating procedures. [The instructions say] you centrifuge for 3 minutes ... typically people with a strong science background are investigational by nature. They think: ?what happens if I centrifuge it for three and a half minutes?? ? says Woody Hydrick, a senior consultant with Fluor Global Locations Strategies in Aliso Viejo, California.
Good manufacturing and laboratory practices
Despite academic barriers, there are options for the interested student. The important thing is to become familiar with current good manufacturing practices (cGMP) and current good laboratory practices (cGLP). Industry experience is one way to get it, and some academic programs may provide opportunities to work with pilot plants. Failing that, there are online courses that could be useful, and organizations like BioInsights offer short courses. Community and technical colleges also may offer courses or associate degrees in biotech manufacturing. Such programs tend to be clustered around areas like California, Massachusetts, Maryland, and North Carolina, where the need for well-trained biotech manufacturing professionals is most acute, according to Mintz.
Forward-thinking undergraduates might have the best opportunity to position themselves for a career. ?If you are ?job focused? rather than degree minded, obtain an undergraduate degree in biotechnology or bioprocess engineering, eschew the Ph.D., take some courses in cGLP and cGMP, and then get a job in the quality control or quality assurance fields. This will open up countless opportunities in the areas of biomanufacturing, regulatory affairs, and business development,? says Mintz.
But all is not lost for the career researcher interested in greener pastures. Experience with a company?s research and development can translate into a manufacturing position. ?Sometimes starting in a different department or division within the company you want to work in will allow you to transfer skills and experience,? says Eileen Dougherty, who is a managing consultant at Search Masters International in Chicago.
In fact, the very nature of small biotech companies can lend itself to such a transition. Manufacturing facilities are almost invariably located close to R&D labs. ?A lot of the reason is knowledge and technology transfer--[companies] are feeling their way into production and manufacturing,? says Hydrick. That proximity can be a bridge to career change.
Not surprisingly, many small companies avoid manufacturing altogether, considering it beyond their means. After all, manufacturing is serious business. It requires strict adherence to standards and protocols, and sterility levels far beyond the reach of the average laboratory. Many therefore turn to contract manufacturing companies.
The facilities at contract manufacturer DSM Pharmaceuticals in Heerlen, the Netherlands, ?are fully compliant with both U.S. and European regulations. There are not many companies that can say that,? says Leendert Staal, president and CEO of DSM. Contract manufacturing will grow with rising numbers of biotech approvals and clinical trials, Staal predicts. Companies like DSM serve a broad spectrum of clients, requiring employees with flexibility and service-oriented personalities, but specific technical knowledge is also critical. ?We look for technical know-how with a full understanding of GMP. If you have that combination, your market value is high.?