US-MA, Associate Scientific Fellow / Senior Scientist, ADL - Structural Characterization 1600811-MZ
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Associate Scientific Fellow / Senior Scientist, ADL - Structural Characterization in ourCambridgeoffice.
In the Analytical Development Laboratories (ADL) of Takeda Pharmaceuticals, Inc. Company in Cambridge, MA where all of the test methods for drug substances and drug products are developed and validated in support of clinical development. ADL scientists work very closely with partner groups such as process chemistry, formulations, discovery, drug safety, regulatory and quality to advance drug candidates from discovery through regulatory submission. ADL scientists also provide strong technical support to commercial product in the market and work in a GLP/GMP compliant environment.
The main focus of this role is to contribute to the structural elucidation of new compounds, impurities and degradants providing rapid and efficient small molecule compound structural characterization by mass spectrometry and NMR analyses in support of drug development activities from discovery, through development, to commercialization. Responsibilities will also include: coordinate and manage internal and external resources. Conduct experiments to determine degradation pathways. Conduct method development, validation, transfer and stability testing for drug substances and drug products using modern analytical techniques such as HPLC and GC. Participate in CMC teams and cross-functional teams to plan analytical and CMC strategy for product development. Review and determine the acceptance of analytical work in terms of accuracy and consistency in compliance with FDA, ICH guidelines and internal SOPs. Prepare and review relevant SOPs, protocols, validation, stability reports, regulatory filings and other technical reports to support drug candidate development and regulatory submissions.
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