Director, Analytical Technical Operations

Job description

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. You will lead Moderna’s Core Analytical Testing & Integrations organization, an approximately 30–50-person team responsible for generating controlled, reproducible and filing-ready analytical data that underpin CMC development and Module 3 (Quality) regulatory submissions. Operating primarily in a non-GMP environment, you will bring together deep technical leadership across separations, RNA and lipid analytics, biophysical and compendial methods, molecular biology, sequencing and microbiology, while overseeing non-GMP release, stability, engineering-run and PPQ-related development support and a limited portfolio of phase-appropriate GMP testing in partnership with QC. You will shape the next evolution of the function by protecting rigorous scientific execution and submission-critical data quality while improving laboratory efficiency, method-performance insight, digital workflows and the connection between development analytical methods and GMP QC operations. Here’s What You’ll Do Lead the Core Analytical Testing & Integrations organization, setting strategy, capacity plans, execution standards and continuous-improvement priorities while safeguarding existing program commitments. Lead approximately 30–50 scientists, analysts, managers and integration specialists across separations and RNA/lipid analytical methods, biophysical, compendial, molecular biology, sequencing and microbiology capabilities. Oversee primarily non-GMP analytical testing supporting end-to-end process development, product characterization, non-GMP release and stability, manufacturing engineering runs and PPQ-related development activities. Ensure ATO generates complete, accurate, reproducible, traceable and filing-ready development analytical data that underpin Module 3 (Quality) regulatory submissions, while supporting Regulatory CMC data requests across products and programs. Provide broad technical leadership across separations, RNA critical quality attributes, lipids, biophysical methods, compendial testing, molecular biology, sequencing and microbiology, including bioburden and endotoxin testing. Maintain reliable non-GMP release and stability execution across the full testing lifecycle, from sample receipt, study planning and test scheduling through data review, reporting and delivery against stability pull and testing commitments. Lead the Integrations team responsible for test and request intake, analyst and assay scheduling, capacity and batching, stability study coordination and management, performance metrics, digital workflows, stakeholder engagement, cross-functional coordination and issue escalation. Establish clear testing priorities, readiness expectations and delivery commitments in close partnership with Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, Quality, Regulatory CMC and Digital/IT. Partner closely with QC and QA on the limited portfolio of phase-appropriate GMP testing required for early-phase material release, establishing qualified analytical coverage, appropriate controls, clear governance and robust records. Build systematic analytical method-performance monitoring across system suitability, variability, control trends, method drift, repeats and atypical results, using those insights to identify risk early and enable method improvements and lifecycle decisions. Work with Analytical Development, Process Development, Science & Technology and QC on method readiness, troubleshooting and transfer, creating a strong bridge between development analytical testing and GMP QC execution. Establish and use operating dashboards covering right-first-time performance, turnaround time, on-time delivery, backlog, capacity utilization, investigations, retests, method performance and stability milestones, and translate emerging trends and constraints into action. Improve laboratory throughput and cost effectiveness through standardized workflows, risk-based planning, cross-training, Lean practices, equipment optimization and automation without compromising scientific rigor, data quality or safety. Modernize Benchling, LabVantage LIMS and related digital workflows, with a particular focus on structured data, study and sample traceability, scheduling and review, while reducing manual handoffs in partnership with Digital/IT. Explore appropriate opportunities to bring Generative AI tools closer to laboratory and analytical operations, including support for knowledge access, structured data interpretation, workflow efficiency and scientific decision support, while maintaining appropriate controls, data integrity and human oversight. Set clear expectations for quality, data integrity, training and EHS, maintaining fit-for-purpose procedures, documentation, investigation and escalation practices appropriate to the intended use of each analytical result. Build a high-performing organization through workforce planning, manager coaching, performance management, clear goal setting, hiring, employee engagement, development, succession planning and structured rotations. Strengthen leadership capabilities across the organization so managers can protect day-to-day delivery while continuously improving scientific, technical and operational performance. Make risk-based cross-functional decisions on priorities, resources and trade-offs while protecting delivery commitments and strengthening collaboration across CMC. Evolve the function, its operating model and its digital systems without disrupting ongoing analytical work or compromising submission-critical execution. Additional duties may be assigned from time to time. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) Education: Degree in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Life Sciences, Engineering, or a related technical discipline. Experience: 15 years of relevant industry experience with a Bachelor’s degree or 10 years of relevant experience with a PhD in analytical development, analytical testing, technical operations, Quality Control, or related CMC laboratory functions. Here’s What You’ll Bring to the Table (Preferred Qualifications) PhD in a relevant scientific or engineering discipline is preferred. Experience leading multi-technology analytical testing supporting development, non-GMP release and stability for mRNA/LNP, vaccines, biologics or other complex modalities. Broad technical fluency across separations, RNA and lipid analyses, biophysical/compendial assays, molecular biology, sequencing and microbiology, with strong scientific judgment. Demonstrated record of generating controlled analytical datasets supporting Module 3 filings, traceable source documentation and regulatory data requests. Strong knowledge of non-GMP data integrity and fit-for-purpose methods, lifecycle management and phase-appropriate GMP requirements for early clinical programs. Experience in analytical trending, method-performance monitoring, investigations and improvements that enable robust handoff from development to GMP QC. Ability to build integrated scheduling, stability, metrics, portfolio prioritization and capacity-planning processes across multiple stakeholders. Experience ev