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Career Story: Analytical Chemist In Pharmaceutical Research

Analytical Chemist In Pharmaceutical Research

Job Title: Analytical Chemist (Pharmaceutical)

Education: BS in Chemistry, Clarkson University •• MS in Analytical Chemistry, Rensselaer Polytechnic Institute •• PhD in Analytical Chemistry, Rensselaer Polytechnic Institute

Previous Experience: I worked in Analytical Departments for a range of biotech or pharmaceutical companies for 11 years prior to my present position.

Job Tasks: My company is involved in pharmaceutical research and development of small molecules and/or polymeric agents to provide improved health for patients around the world. The corporation (Genzyme) has pioneered the diagnosis and treatment of rare genetic ailments due to problems with carbohydrate metabolism. Within my particular job focus, I am engaged in providing analytical support to assist in the discovery of novel potential therapeutics, and once discovery has been optimized, towards analytical development to support clinical development through to completion of a new drug application (NDA).

A description of of my research and development efforts within the past 10 years is summarized below: Analytical R&D, Senior Scientist: Global Tolevamer Project Team member (coordinated work of 4 other scientists plus 1 direct report); discovery through Phase III clinical development of tolevamer, a polymeric drug for C. difficile colitis; responsible for all analytical chemical manufacturing and control for tolevamer throughout development; polymer characterization and impurity analysis using HPLC, GC, LC-MS, GC-MS, FTIR, DSC, TGA, ICP, IC, prep HPLC; methods development, validation, transfer and QC release/stability; Phase I clinical development of Genz29155 (anti-TNF agent); clinical development of Genz112638 (a small-molecule to treat the lipid storage disease caused by Gauche's syndrome).

During a typical day, I manage a staff scientist's benchwork performing chemical characterization or impurity analysis. Studies are often focused towards verifying active pharmaceutical ingredient and formulated drug product stability. I may myself become engaged in select chemical testing, often involved in optimizing analytical methodologies and subsequently validaiting the methods. Methods transfer to manufacturing facilities is commonplace. This work entails statistical assessement for proving assay validity, report writing of study results, analytical methods and standard operating procedure writing, and continual review of regulatory guidances to assure proper completeness and accuracy for the reported information.

Best and Worst Parts of the Job: Remaining updated with evolving scientific principles, new state of the art techniques, and more capable analytical methodologies, as well with srategies towards solving the battery of problems that are commonplace in pharmaceutical development (stability, formulation issues, analytical methods transfer and validation requirements), is the best part of the job. Keeping up with the rapidly changing instrumental advances is meaningful and necessary, as well as filled with its many challenges. The worst part is finding skilled scientists upon which to entrust some of the workload.

Job Tips: Always seek to achieve the highest possible degree of academic education, even if it is acquired at a paced fashion while working in the field for a company. Never back away from the need to remain contemporary and updated with the scientific advances being gained throughout the industry. If a particular job doesn't nourish your skillset with continual updating of your skillset, don't hessitate to seek change.

Additional Thoughts: The greater Boston region is continally being infused with both innumerable biotech companies, with considerable innovation continually evolving from Harvard and MIT, as well as large pharmaceutical companies. This is likely to lead to a broad range of employment possibilities within scientific fields related to the drug industry.

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