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The demand for skilled biotech professionals will continue to outpace the supply of qualified applicants.

by Dee Fairfield

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The Hottest New Careers of the Biotech Boom
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iotech is one industry that won't experience a shortage of job openings for the forseeable future. The harnessing of massive computing power for both research and development is enabling the industry to emerge from the Dark Ages of trial and error methods to a brave new world of gene-based therapies, bio-engineering and nano-medicine.
     Brand-new strategies for attacking diseases and disabilities are being born practically by the day. Each product opportunity takes the efforts of hundreds or thousands to exploit commercially, creating an insatiable demand for trained biotech professionals. If the personal computer industry is any gauge, the demand for biotech talent won't be satisfied for at least two decades.

     Here are the 7 areas within the biotech/pharmaceuticals industry that will offer the most promising career opportunities in the coming decades.


1. BIOINFORMATICS

     Bioinformatics is the use of computing power to accelerate research, development, regulatory approval, quality control, production and marketing of medicines. It's the backbone of the biotech boom. Its most famous achievement is the sequencing of the human genome, but that has only launched the more demanding quest to sequence the proteome and economically develop therapies through the efficiencies of computer-based analysis and/or simulation of experimental or clinical data.

     The field of bioinformatics offers high-paying careers for applied mathematicians, biostatiscians, bioinformatics scientists and bioinformacians, as well as the usual array of IT professionals.

     Applied mathematicians are the field's core conceptual minds. They are typically expected to have a PhD/MS in computational mathematics, applied mathematics, engineering, computer science or the like. They are also expected to be agile thinkers adept at combining concepts and techniques from mathematics to fields like biology, chemistry and software engineering. More senior positions require considerable experience with protein informatics, computational chemistry, large-scale sequence databases and image-processing routines in relation to proteins, protein and gene expression, and peptide sequencing.



     Biostatiscians are the workhorses, devising statistical data and analyses pertaining to proteomics, population studies, clinical trial designs and elucidating clinically relevant surrogate markers from gene/protein expression profiles and genetic disease association studies. They are typically required to have a Phd or MS in biostatistics, together with a familiarity with basic concepts from disciplines like molecular biology, organic chemistry and cell biology. More senior positions may require several years of experience analyzing and interpreting statistical results and applying statistical techniques in a pharmaceutical research environment.

     Bioinformaticians develop the software that apply computing power to data to create the bioinformatics pipelines used to speed up R&D and other functions of biotech companies. They are expected to combine fluency in languages like perl, C/C++, Java and SQL with one or more degrees in molecular biology, biochemistry, genetics and related fields.

     As in most biotech fields, for many bioinformatics positions, an MS is generally considered the equivalent of 2-3 years of industry experience and a PhD, 4-5 years of experience.


2. REGULATORY AFFAIRS/ASSURANCE

     In the biotech/pharmaceuticals industry years or decades of expensive R&D investment can only be validated by the regulatory approval of the FDA and analogous agencies in Europe, Japan and elsewhere. The recent acceleration of the R&D process is creating a growing backlog of promising new medicines awaiting approval to undertake various stages of clinical trials. It is the job of Regulatory Affairs directors, managers, auditors and specialists to guide a product through the regulatory maze to ensure approval and shorten the time to market.

     At the highest level (typically Director of Regulatory Affairs), a career in regulatory affairs/assurance is somewhat akin to being a campaign manager for a political candidate. It not only demands the scientific credibility of a PhD in pharmacology or PharmD, but intimate familiarity with both the regulations and the personalities at the FDA and other regulatory bodies. Equally important is a demonstrated ability to provide effective guidance and leadership to the many employees involved in taking a new product from R&D through regulatory approval to manufacturing and, finally, to the market. Strong verbal skills and powers of persuasion are a prerequisite to a successful career in regulatory affairs.

     Auditors/auditing managers are the rank-and-file of the regulatory affairs team. They conduct continuous checks to ensure that the company conforms to standards and procedures to ensure that approved products don't run afoul of regulations. An auditing manager is usually expected to have a BS in a biological or physical science and 5-7 years of experience with regulatory affairs in the biotech industry. They are expected to have strong verbal skills for interaction with site and regulatory workers, as well as routine reporting and documentation. PAGE 2

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"A career in regulatory affairs/assurance is akin to being a campaign manager for a political candidate."