# Director, Analytical Technical Lead, Global Tech Operations (GTO) at AstraZeneca

AstraZeneca is hiring a Director, Analytical Technical Lead, Global Tech Operations (GTO) in Singapore, Singapore. Level rates it Little AI ●○○○; you can [apply on AstraZeneca](https://jobsbylevel.com/go/cc14c817-e8b3-47f3-8f6b-c1c7ce42f11d?utm_medium=ai-agent).

AI Level 1, AI centrality 35 out of 100. Singapore - Tuas.

## Details

- Company: [AstraZeneca](https://jobsbylevel.com/companies/astrazeneca)
- AI level: AI Level 1 (score 35 out of 100)
- Location: Singapore - Tuas
- Posted: November 11, 2026
- Apply: https://jobsbylevel.com/go/cc14c817-e8b3-47f3-8f6b-c1c7ce42f11d?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=director-analytical-technical-lead-global-tech-operations-gto-at-astrazeneca-efe2bc

## Description

Introduction Working across BPD and Operations team members, the incumbent builds where and how testing is performed, including in the QC laboratory, on the manufacturing floor, or through inline and at-line applications. The role also strengthens future readiness through method robustness, right-sized testing, shelf-life strategy and extension, statistical assessment, comparability planning, analytical trending, and opportunities for Process Analytical Technology (PAT), simplification, digitalization, and automation. The role provides analytical leadership for regulatory submissions and post-approval changes, including authoring BLA and post-approval analytical sections, responding to agency questions, and establishing scientifically justified comparability criteria. Main Duties and Responsibilities Define and maintain the end-to-end analytical strategy for assigned products, integrating commercialization, control strategy, supply continuity, and lifecycle requirements. Assess the robustness and commercial readiness of analytical methods developed by BPD, ensuring they are suitable for transfer, validation, routine use, and future product or process changes. Right-size the analytical approach by challenging unnecessary complexity and non-value-added testing while maintaining product quality, patient safety, and regulatory compliance. Develop testing location and deployment in partnership with BPD and relevanteam membersrs, evaluating QC laboratory, manufacturing-floor, inline, and at-line options based on scientific and operational need. Future-proof methods by considering scalability, transferability, network deployment, shelf-life requirements and extension opportunities, Process Analytical Technology (PAT), digitalization, automation, and readiness for post-approval change. Apply statistical thinking and tools such as JMP to evaluate method robustness, interpret data, establish comparability criteria, monitor trends, and support data-driven decisions. Author and review BLA and post-approval analytical content, and lead responses to regulatory agency questions on methods, specifications, validation, comparability, control strategy, and product quality. Establish risk-based comparability strategies and acceptance criteria for post-approval changes, tailored to the product, method, and nature of the proposed change. Lead analytical trending and stability-data evaluation for commercial products to monitor method performance, support shelf-life assignment and extension, identify shifts or emerging issues, strengthen product quality oversight, and drive continuous improvement. Partner across Technical Transfer, Manufacturing Science, Quality Control, Quality Assurance, Regulatory, Operations, BPD, and external networks to ensure analytical plans are aligned, executable, and responsive to business and supply priorities. Provide scientific leadership and clear recommendations on complex analytical issues, balancing technical rigor, regulatory expectations, operational feasibility, and business needs. Drive simplification and continuous improvement in analytical lifecycle management, including adoption of PAT, advanced analytics, and other technologies that enable more efficient, real-time, and predictive ways of working. Key Accountabilities Accountable for: an approved, coordinated analytical strategy for each assigned product that supports commercialization, reliable supply, regulatory commitments, and lifecycle management. timely, evidence-based assessment of method robustness and commercial readiness, with clear identification and mitigation of transfer, validation, and routine-use risks. efficient, scientifically justified testing strategy, including recommendations on testing scope, location, deployment model, and appropriate use of PAT. high-quality analytical content in regulatory submissions and for timely, scientifically sound responses to agency questions. fit-for-purpose comparability criteria, shelf-life strategy and

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/director-analytical-technical-lead-global-tech-operations-gto-at-astrazeneca-efe2bc

Source: https://jobsbylevel.com/jobs/director-analytical-technical-lead-global-tech-operations-gto-at-astrazeneca-efe2bc

## Cite this page

Level. https://jobsbylevel.com/jobs/director-analytical-technical-lead-global-tech-operations-gto-at-astrazeneca-efe2bc.

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