Director, Analytical Technical Lead, Global Tech Operations (GTO)

About the role

AstraZeneca is looking for a Director, Analytical Technical Lead for Global Tech Operations (GTO). Working across BPD and Operations, the incumbent defines how testing is performed in the QC laboratory, on the manufacturing floor or through inline and at-line applications, and leads analytical leadership for regulatory submissions and post-approval changes, including BLA and post-approval analytical sections.

Key responsibilities

• Define and maintain the end-to-end analytical strategy for assigned products, covering commercialization, control strategy, supply continuity and lifecycle requirements.
• Assess the robustness and commercial readiness of analytical methods developed by BPD, and right-size the testing approach.
• Develop testing location and deployment, and future-proof methods for transfer, shelf-life extension, PAT, digitalization and automation.
• Use statistical tools such as JMP to evaluate method robustness, interpret data, set comparability criteria and monitor trends.
• Author and review BLA and post-approval analytical content, and respond to regulatory agency questions.
• Establish risk-based comparability strategies and acceptance criteria for post-approval changes, and lead analytical trending and stability-data evaluation.
• Partner with Technical Transfer, Manufacturing Science, Quality Control, Quality Assurance, Regulatory, Operations and BPD, and provide scientific leadership on complex analytical issues.

Required profile

• Solid experience in analytical science, analytical development, QC, CMC or a related field in the biopharmaceutical industry.
• Experience assessing the robustness and commercial readiness of methods developed in BPD.
• Experience supporting regulatory submissions, including analytical sections of BLA or equivalent submissions.
• Deep knowledge of statistics and data analysis tools, including JMP.
• Degree or equivalent experience in a relevant scientific field; advanced degree or equivalent experience preferred.
• Desirable: biologics experience, inline/at-line or manufacturing-floor analytical deployment, global post-approval change experience.