Senior Scientist, Analytical R&D
仕事内容
Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex biologics to support drug substances and drug products.
Operate at the interface of biology, chemistry, and lab informatics to enable robust, regulatory-compliant analyses.
Plan and execute release, characterization, and stability testing methods for clinical trial material, applying QbD and DOE principles.
Design and optimize assays, document results, and manage cross-functional transfer of methods in GMP/GLP environments.
Apply separations techniques (UPLC/HPLC, SEC, RP, IEX), immunoassays (ELISA), PCR/DNA, and mass spectrometry for large molecules as needed.
Lead in multidisciplinary teams, publish findings, and support regulatory submissions and scientific communications while adapting to a fast-changing landscape.
Operate at the interface of biology, chemistry, and lab informatics to enable robust, regulatory-compliant analyses.
Plan and execute release, characterization, and stability testing methods for clinical trial material, applying QbD and DOE principles.
Design and optimize assays, document results, and manage cross-functional transfer of methods in GMP/GLP environments.
Apply separations techniques (UPLC/HPLC, SEC, RP, IEX), immunoassays (ELISA), PCR/DNA, and mass spectrometry for large molecules as needed.
Lead in multidisciplinary teams, publish findings, and support regulatory submissions and scientific communications while adapting to a fast-changing landscape.
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