xiaojing zheng

· Led Product Quality team overseeing over 60 AstraZeneca biologics programs from pre-clinical development through first wave submissions and CMC launch support. · Reviewed and approved CMC technical documents; supported product development, technology transfers, analytical activities (qualification, validation, transfer, bridging), and reference standard programs. · Served as secretary and advisor to AZ Control Strategy Steering Committee; overseeing approval and implementation of testing strategy, release and stability specifications, and comparability strategies throughout the entire product lifecycle. · Provided risk-based, data-driven, and phase-appropriate technical quality support to CMC teams; taking responsibility for CMC strategies and ensuring their successful delivery. · Managed oversight of external testing labs, contract manufacturers (DS/DP/L&P), OOS and product complaint investigations, lot disposition, and audit support at the Gaithersburg site. · Reviewed and approved regulatory submissions; advised on RTQs and country-specific filing strategies. · Engaged with global regulatory authorities and external partners to elevate AZ’s CMC strategy (e.g., CEPI comparability template working group); contributed as core member of internal Expert. · Working Group for ICH Q6 and served on Biologics IND/IMPD Template, Next generation Manufacturing Technical core team and Inhaled Biologics Control Strategy Alignment Committees. · Supervised a highly productive team; manage headcount, expense and project budgets.

• 13 years of experience in the analytical development of biotherapeutic drugs • Familiar with CMC regulatory dossier (IND and BLA); analytical lead for multiple IND filings, BLA/MMA applications, and comparability studies • Broad and in‐depth understanding and experience of analytical development, CQAs assessment, and control strategy for a wide range of therapeutic modalities • Provided strategic direction on biologic candidate selection, control strategy, risk assessment and spec setting; established platforms to enable robust collaboration with key internal partners from development to manufacturing • Reviewed and approved CMC regulatory documents, SOPs, assay qualification protocols & reports, technology transfer documents and end-of-study reports/memos; prepared patent applications and publications that enhance the team’s scientific and business value • Implemented innovative strategies to improve existing processes or solve complex issues based on regulatory flexibility and state-of-the-art technologies • Highly effective in managing timelines, resources, budgets and coordination with internal cross-functional teams and external partners

· Collaborated with multiple Case research groups on phosphoproteome analysis, expression proteomics using label‐free/stable isotopic quantification, protein identification and glycan analysis · Identified PTMs on various proteins of the human amidohydrolase superfamily (collaborated with SGX Pharmaceuticals, Inc.) · Studied protein structure and dynamics, protein‐protein and protein‐ligand interaction using hydrogen/deuterium exchange (HDX), hydroxyl‐radical mediated footprinting methods and computational structure prediction (Rosetta) guided by structural mass spectrometry data