Associate Director, Global Analytical Lifecycle Management

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 with 5+ years of experience OR PhD 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 statistical expertise in continued performance verification, equivalence testing, and comparability assessment.
• Direct participation in pre-approval inspections, health authority meetings, or formal regulatory responses.
• Experience implementing controlled digital analytical tools, data-analysis templates, laboratory information systems, or analytical automation.
• Demonstrated mentoring, coaching, or matrix technical leadership experience.