Senior Scientist New Modalities, Analytical Full-time

Job Title

Introduction to role: Are you ready to define how cutting-edge peptide, oligonucleotide and other new modality medicines are measured, controlled and released from early development through commercial launch? In this role, you will set the analytical vision and deliver the strategies that safeguard quality, accelerate decisions and enable robust supply so life-changing therapies reach patients sooner.

You will join a fast-moving, cross-functional environment where analytical science sits at the center of product and process understanding. You will partner with process chemists, formulators, engineers and regulatory experts to turn data into confident decisions, using modelling, simulation and emerging AI approaches to raise the bar on robustness and speed. Do you thrive on solving complex problems and seeing your work translate into tangible impact for patients and the business?

Accountabilities

• Analytical Strategy and Control: Define end-to-end analytical and control strategies that de-risk development and underpin reliable clinical and commercial supply for peptides, oligonucleotides and other new modalities.
• Method Lifecycle Ownership: Develop, optimise, validate and transfer fit-for-purpose analytical methods; apply risk-based approaches to ensure robustness and steward methods across their lifecycle.
• Regulatory Leadership: Author high-quality sections of global regulatory submissions and craft clear, timely responses to questions, applying current ICH and major health authority guidance to enable approvals and post-approval changes.
• Cross-Functional Delivery: Partner with process, formulation, engineering, regulatory, quality and external collaborators to align on critical quality attributes and control strategies that meet project goals for quality, cost and timelines.
• Commercialisation Readiness: Provide deep technical expertise and development experience to establish and optimise commercial supply strategies that scale effectively and consistently.
• Digital and Data Innovation: Champion data-centric ways of working, leveraging digital tools, modelling and simulation, and AI-enabled approaches to improve robustness, efficiency and decision-making.
• Investigation and Risk Reduction: Lead root-cause investigations for OOS, OOT and deviations; define impactful corrective and preventive actions that prevent recurrence and strengthen systems.
• Quality and Compliance Leadership: Uphold cGMP, SHE and data integrity standards; nurture a culture of quality and continuous improvement that anticipates issues and embeds best practice.

Essential Skills/Experience

• 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 methods; 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 strong 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 deviations; define effective corrective and preventive actions (CAPA).
• Uphold cGMP, SHE, and data integrity standards; foster a culture of quality and continuous improvement.

Desirable Skills/Experience

• Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or related discipline.
• Hands-on expertise in chromatographic and electrophoretic techniques and characterization methods relevant to peptides and oligonucleotides (e.g., LC/UPLC, LC–MS, CE, IC, SEC, UV, qPCR, HILIC).
• Experience applying QbD, DoE and statistical techniques to method development and control strategy design.
• Track record of late-stage development, specification setting and successful method validation/transfer into GMP manufacturing or commercial sites.
• Direct authorship of CMC sections and participation in global health authority interactions across multiple regions.
• Familiarity with PAT, stability modelling, and in-silico/chemometric tools to accelerate product and process understanding.
• Proficiency with digital lab systems (e.g., LIMS, ELN) and data integrity by design.
• Experience leading external partners (CROs/CDMOs) and coordinating complex, multi-site analytical networks.
• Strong communication that turns complex data into clear recommendations for diverse audiences.

Why AstraZeneca: Here, analytical science propels bold ideas into therapies that change lives. You will work shoulder to shoulder with curious, accomplished colleagues who combine kindness with ambition, bringing unexpected teams into the same room to unlock fresh solutions. We embrace digital and data to move faster with greater confidence, invest in the latest tools, and back you with constructive coaching so you can stretch your impact. Your expertise will shape pivotal decisions, from defining critical quality attributes to enabling global submissions, all while contributing to a mission that puts patients at the center and rewards initiative, ownership and collaborative problem-solving.

Call to Action: Step into a role where your analytical leadership will set new standards for new modalities and speed vital medicines to patients—take the next step in your career with AstraZeneca today!