Scientist III, Analytical Development and Clinical QC

Lead analytical method validations, transfers, and compendia verification across clinical development; serve as analytical lead for late-stage CMC programs (Phase 3 through commercialization); develop and implement end-to-end analytical strategies for key late-stage biologics programs, including control strategy and QC testing oversight; author regulatory submissions and respond to health authority queries; collaborate cross-functionally with PDCS, Regulatory, QA, and external QC labs; require advanced degree and extensive experience in chromatography, CE-SDS/cIEF, spectroscopy, bioassays, and regulatory documentation; in-lab work environment with on-site office requirement (minimum four days per week in the office) at AstraZeneca Alexion, US location; expected to manage method validation/transfer activities, quality attributes, QA alignment, and regulatory CTD documentation.