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Tips and Career Guide to Biotech:

About this book

"Biotechnology," or "biotech" for short, refers to the application of biological research techniques to develop products and processes using biological systems, living organisms, or derivatives of organisms. Biotech processes have been used for thousands of years, yet the industry we know today is scarcely more than a quarter century old. The industry is rapidly growing, it tripled in the 1990s, which translates to rapidly growing career opportunities as well.

Read an excerpt from the Vault Career Guide to Biotech

Departments in a Biotech Company
Biotech companies focused on healthcare applications contain all the major departments of conventional pharmaceutical companies -- R&D, operations, quality control, clinical research, business development and finance and administration. In fact, the top 10 biotech companies are essentially mid-cap pharmaceutical companies. Each department houses several functional groups, or specific, logically related areas of activity. The three charts below illustrate how departments and functional groups are organized in different size companies.

As you think about a career in the biotech industry, it is useful to identify the general area(s) where your primary interests and aptitudes lie. The organization charts below provide a general map of the terrain. Note that the charts build on one another, with more groups evolving as a company grows from a small organization (fewer than 50 people) to a medium-size organization (51-300 people) to a large organization (over 300 people). Before discussing the basic career paths, lets take a closer look at how functional groups are organized in different departments.

Research and development

The research and development (R&D) department is responsible for discovering promising drug candidates. The three major functions include discovery research, bioinformatics, and animal sciences. The discovery research function is responsible for performing experiments that identify either targets on the cell or potential drug candidates. The animal sciences function provides cell cultures, grows microorganisms, and manages the care of animals used in discovery research. The extensive data generated from experiments is analyzed with the assistance of the bioinformatics function, which assists discovery research in identifying the most biologically active compounds.

Operations

The operations department is responsible for making commercial quantities of a candidate drug available. Once a promising drug candidate has been identified, the process/product development function determines how to "scale up" quantities of a product to make enough available for clinical trials, since laboratory-size quantities are usually very small. When a product emerges from clinical trials successfully, the manufacturing and production function creates the final product -- complete with packaging and labeling -- that we see on pharmacist and drugstore shelves. Also housed under the operations umbrella is the environmental health and safety function, which assesses the environmental impact of a potential product.

Clinical research

Once a drug candidate emerges from R&D, the clinical research department takes over and becomes responsible for shepherding the drug through the FDA approval process. The clinical research function sets up and manages the clinical trials needed to determine a drug's safety and effectiveness or "efficacy." The regulatory affairs function ensures that all FDA reporting requirements are completed and submitted in a timely manner. Finally, the medical affairs/drug information function is responsible for overseeing all the information related to a drug candidate.

Quality

The quality department has groups focusing on quality control, quality assurance, and validation. These groups ensure that products are manufactured along rigorous, consistent standards of quality. This usually entails that well-defined and documented procedures are followed when producing a product either for clinical trials or as an end product.

Finance and administration

The finance and administration department contains these two functional areas as well as information systems and legal. All activities relating to the financial management of the company, its legal relationships to investors, creditors, and employees are housed in this department. The company-wide computer systems -- separate from computing specifically directed at analyzing research data -- are also managed here.

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