Senior Scientist, Quality CMC
AQUE · Portage, IN · Posted Jun 30, 2026
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Job Summary:
The Senior Scientist, CMC Quality, bridges analytical science and product performance, providing scientific leadership to distinguish analytical artifacts from true product, process, or manufacturing risks. This role drives complex investigations, informs quality-critical decisions, and partners cross-functionally to ensure sound, risk-based outcomes throughout the product lifecycle.
RESPONSIBILITIES
•Serve as QC’s primary interface to AR&D and Engineering, connecting analytical findings to process variability, formulation behavior, manufacturing deviations.
•Support PQR/APQR product quality narratives, stability trend interpretation.
•Lead and provide scientific oversight for complex OO