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Stefanini Group is hiring for a Research Associate Scientific III Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav - (/ Description:Perform analytical method development, validation, and chemical analysis associated with drug products and impurities including LC or with MS detection. Perform validation of analytical methods for quantitative analysis. Specifically, this position is expected to: Execute analytical testing following written test procedures and study protocols, document results per GXP regulations, and review data for accuracy and completeness. Apply analytical separation and detection techniques for complex impurity identification/quantification. Execute method validation and transfer studies. Assess the technical feasibility of complex research and design concepts. Contribute to the analytical problem-solving efforts to meet urgent business needs. Collaborate with other functions such as project management, regulatory, formulation, engineering, manufacturing, and quality control in project teams. Collaborate with Baxter external partners to ensure successful execution of analytical testing and study designs. Develop knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities. Develop knowledge and understanding of cGxP and related regulations and guidance. Maintain focus on meeting both external and internal customer expectations.
QualificationsBachelor's degree in relevant scientific discipline (chemistry, pharmaceutical sciences) with 3-5 years' experience or Masters' degree with 1-3 years' experience or PhD with 0-3 years' experience. Familiar with MS and/or LC/MS analysis. Familiarity with analytical method development, validation, and transfer in pharmaceutical regulated laboratories is a plus. Awareness of ICH, USP guidelines and cGxP regulations. Familiarity and hands-on experience with HPLC, UV, MassHunter and other analytical instruments and software is a plus. Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills. Possess relevant writing and computer skills. Ability to design experiments and draw meaningful conclusions from lab data. Quality oriented. Ability to adapt to changes and to work in a team environment.