Associate Director, Global Analytical Lifecycle Management

Associate Director, Global Analytical Lifecycle Management This position can be located at any of the following AstraZeneca sites: Gaithersburg, MD | Rockville, MD | Tarzana, CA Introduction to role Are you ready to lead the analytical lifecycle that enables cutting-edge cell therapies to reach patients safely and at speed? In this role, you will set the strategy and standards that keep complex analytical methods robust, transferable, and inspection-ready from late-stage development through commercialization and post-approval. You will serve as a key analytical subject matter expert, partnering across Quality, Manufacturing, Regulatory, and Development to shape CMC strategy, de-risk scale-up, and ensure global testing networks operate with rigor and consistency. Do you see yourself orchestrating method transfer, validation, comparability, and lifecycle monitoring so that pivotal and commercial programs deliver with confidence? Accountabilities • Analytical Lifecycle Strategy and Planning: Own the product-level analytical lifecycle strategy and network-level governance standards for late-stage and commercial cell therapy products, aligned to control strategy and program milestones; define risk-based plans covering transfer, validation, continued performance verification, and critical reagent and reference standard lifecycle. • Lifecycle Handover and Readiness: Define and govern the analytical lifecycle handover from Analytical Development to QC, including transfer-package expectations, readiness criteria, decision points, and evidence required to demonstrate that methods are fit for intended use across the testing network. • CMC Change Assessment and Analytical Change Control: Assess analytical impact of process, material, equipment, method and/or site changes; set product-level change control strategy, including bridging, comparability, validation, and post-change monitoring in collaboration with Regulatory and Quality. • Method Transfer, Validation, Comparability, and Bridging: Define transfer and validation strategies across internal and external networks; provide scientific oversight of protocols, reports, and statistics aligned with GMP and ICH Q2(R2)/Q14; lead comparability and revalidation strategies for method and platform changes and multi-site implementation. • Method Performance Oversight and Risk Leadership: Define network method-performance monitoring and assess cross-site trends, drift, and lifecycle risks. • Regulatory CMC and Inspection Support: Provide analytical lifecycle content and technical review in support of regulatory submissions, variations, supplements, and responses to health authority questions; serve as the analytical lifecycle SME during inspections and audits, in partnership with Regulatory CMC and Quality. • PPQ, Launch Readiness, and Commercial Lifecycle Support: Define and govern analytical readiness requirements for PPQ, launch, and testing-network expansion, including QC readiness criteria, escalation pathways, and continuity strategies for critical reagents, reference standards, testing capacity, and alternate-site capability. • Cross-Functional Leadership and Governance: Represent analytical lifecycle on product and CMC teams; lead governance forums to frame decisions and escalate risks; drive continuous improvement and harmonization of global analytical lifecycle processes, and technical guidelines to strengthen method robustness and scalability across cell therapy modalities. Essential Skills/Experience • BS in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 10+ years of experience OR MS in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 5+ years of experience OR PhD in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 3+ years of experience. • Significant progressive experience in the biopharmaceutical industry, including cell therapy, gene therapy, or other advanced therapy medicinal products. • Demonstrated experience leading analytical lifecycle activities for late-stage, pivotal, PPQ, commercial, and/or post-approval programs. • Strong technical expertise in cell therapy analytical methods, such as cell-based potency assays, flow cytometry, molecular assays (qPCR, dPCR), identity, purity, safety, residuals, and microbiological release testing. • Proven experience defining and overseeing method validation, transfer, comparability, bridging, controlled method change, and continued performance monitoring in a GMP environment. • Experience authoring or providing technical oversight of analytical CMC regulatory content, including IND/IMPD, BLA/MAA, variations, supplements, and responses to health authority questions. • Strong working knowledge of GMP, data integrity, quality risk management, investigations, change control, CAPA, and inspection readiness. • Working knowledge of ICH Q2(R2), ICH Q14, and analytical lifecycle management principles. • Demonstrated ability to lead complex cross-functional technical workstreams, influence without direct authority in a matrix organization, and communicate risks and recommendations clearly to senior stakeholders. • Excellent technical writing, data interpretation, and presentation skills. Desirable Skills/Experience • Direct experience with CAR-T, autologous or allogeneic cell therapy, lentiviral vector, in vivo gene therapy, or gene-editing products. • Experience supporting commercial launch, commercial-site introduction, or post-approval analytical change program. • Experience with multi-site QC networks, contract testing laboratories, CDMOs, or global external partner models. • Experience with critical reagent and reference standard qualification, bridging, and lifecycle management. • Applied s