Senior Manager, CMC Analytical Sciences
Remote · United States
Job Summary
Lead analytical activities for vaccine CMC analytical sciences by external laboratories and CDMOs; oversee development, qualification, validation, and transfer of analytical methods for vaccine drug substance and product; design and execution of stability programs; provide SME support for investigation of OOS/OOT results and deviations; author/review analytical sections of global regulatory submissions (IND, IMPD, BLA, MAA) and guidance on specification setting and CQA identification; partner across CMC to define in-process controls and comparability strategies; manage reference standards and sample inventories; ensure regulatory-aligned data compilation and interpretation.
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