Piscataway, NJ, 08854, USA
18 hours ago
Senior Scientist, Analytical R&D
Description: Research Scientist, Analytical Method Development fulfills a critical role in supporting the analytical development and validation of testing methods for the Analytical R&D laboratory, to characterize drug substance, raw materials, and drug products. The individual is a part of the Analytical Method Development team which develops, validates, and qualifies testing methods for active pharmaceutical ingredients, excipients and dosage forms, including reverse engineering of reference products. Essential Functions: + Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis. + Development and optimization of new and existing analytical methods for qualification, release testing of products + Provide timely responses to internal and external inquiries. + Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities. Expand analytical capabilities of the Analytical Group. + Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, purity of components. + Evaluate, recommend and implement new analytical technologies and instrumentation for testing Additional Responsibilities: + Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance. + Leads team members on assigned projects, as required. + Participates and leads scientific discussions on projects with cross-functional team.
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