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US-Seattle-Washington: Senior Scientist - Analytical Chemistry

Date: 25-Jun-2013
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Senior Scientist - Analytical Chemistry

* Direct the development, optimization and qualification/validation of analytical methods for drug substances and drug products. * Manage technical transfer of methods as required. * Create and review technical documents including analytical method development reports, method validations protocols and reports, and standard operating procedures in compliance with regulatory requirements. * Create and review regulatory filings such as INDs and NDAs. * Maintain a personal laboratory and contribute to the development of analytical methods as well as investigate and resolve various analytical and technical issues for assigned projects. * Provide technical leadership, guidance and mentoring to laboratory staff. * Effectively communicate on a timely basis with management and team members. * Represent functional area and projects at team meetings as required.

* BS/MS in Chemistry with a minimum of 10 years of experience in analytical chemistry for bio/pharmaceutical industry, or * PhD in Chemistry with a minimum of 5 years of experience in analytical chemistry for bio/pharmaceutical industry * Development experience with small molecule drugs required. * A hands-on experience and in-depth knowledge in analytical chemistry across a wide range of technologies for the analysis of small molecules, peptides, proteins and polymers. * Proven scientific and technical ability to design and execute method development and validation experiments, analyze and present data, author and review protocol and reports, in support of regulatory submissions. * Experience in a QC environment desired. * Strong knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals. * Highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and corporate objectives * Excellent analytical, technical writing, communication and data management skills

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