SeniorScientistNewModalities,Analytical

Define and deliver analytical strategies and robust control strategies for peptide, oligonucleotide, and other new modality drug products across clinical through commercialisation., Develop, optimise, validate, and transfer analytical apply risk-based approaches to ensure method robustness and lifecycle stewardship., Author and contribute to the authoring of regulatory filings and prepare highquality responses to regulatory queries, applying sound knowledge of regulatory guidelines (e. g. , ICH, EMA, FDA) and other territorial requirements., Work collaboratively with process chemists, formulators, engineers, project leads, regulatory professionals, quality assurance and external partners to achieve successful delivery of the project portfolio., Provide technical expertise and drug development experience to establish and optimise commercial supply for AstraZeneca development projects meeting quality, cost, and time targets., Champion data-centric ways of working, leveraging digital tools, modelling and simulation (M&S), and emerging AIenabled approaches to enhance robustness, efficiency, and decisionmaking., Lead rootcause investigations for out of specification (OOS), out of trend (OOT), and define effective corrective and preventive actions (CAPA)., Uphold cGMP, SHE, and data integrity foster a culture of quality and continuous improvement.