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

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 extension, and analytical oversight of post-approval changes. • effective commercial-product trending, escalation of emerging analytical risks, and translation of data into corrective, preventive, or continuous-improvement actions. • cross-functional alignment and decisions that protect product quality, compliance, supply continuity, and long-term analytical capability. Essential Requirements • Solid experience in analytical science , analytical development , QC , CMC , or a related subject area within the biopharmaceutical industry . • Agility in analytical methods for commercial products , including method readiness, lifecycle management, validation, transfer, specifications, and control strategy. • Experience assessing the robustness and commercial readiness of methods developed in BPD is required, including understanding of what is needed to transition assays successfully into an Operations environment. • Agility to define or influence analytical strategy across product development, commercialization, and post-approval lifecycle management is required. • Experience supporting regulatory submissions , including authoring analytical sections for BLA or equivalent submissions and addressing regulatory agency questions. • Solid understanding of comparability , analytical support for post-approval changes, and the establishment of scientifically sound acceptance criteria. • Experience with analytical trending , commercial product monitoring, and use of analytical data to inform product quality oversight is required. • Deep knowledge of statistics and data analysis tools, including JMP , and the ability to apply statistical methods to analytical robustness, comparability, trending, and problem-solving. • Agility to partner and collaborate with Technical Transfer, QC, Manufacturing, Quality, Regulatory, Operations, and BPD team members. • Strong communication and influencing skills with the agility to explain complex analytica