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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.