Director, Analytical Technical Operations

ModernaTX • Norwood, MA

19h • Onsite

About The Position

Moderna is hiring a Director to lead its Core Analytical Testing & Integrations organization at its Norwood, Massachusetts campus. The approximately 30–50-person organization generates controlled, reproducible, filing-ready analytical data supporting CMC development and Module 3 (Quality) regulatory submissions. The work is primarily non-GMP and spans separations, RNA and lipid analytics, biophysical and compendial methods, molecular biology, sequencing, and microbiology. The function also supports non-GMP release, stability, manufacturing engineering runs, PPQ-related development activities, and a limited portfolio of phase-appropriate GMP testing in partnership with QC.

The Director will set organizational strategy, capacity plans, execution standards, and continuous-improvement priorities while protecting program commitments and submission-critical data quality. The role is responsible for reliable testing and stability execution, test intake and scheduling, portfolio prioritization, performance monitoring, digital workflows, and coordination with Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, Quality, Regulatory CMC, QC, QA, and Digital/IT. The Director will strengthen method-performance monitoring and the bridge between development analytical methods and GMP QC operations, while improving laboratory efficiency, data quality, and operational insight.

The role also includes evolving digital systems and workflows, including Benchling and LabVantage LIMS, and exploring appropriate uses of Generative AI with suitable controls and human oversight. The Director sets expectations for quality, data integrity, training, and EHS, and builds organizational capability through workforce planning, hiring, manager coaching, performance management, employee development, and succession planning. The position is 100% onsite in Norwood, Massachusetts.

Requirements

• Degree in Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Life Sciences, Engineering, or a related technical discipline.
• 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.

Nice To Haves

• PhD in a relevant scientific or engineering discipline.
• 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 and 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, 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 evolving ELN/LIMS, ideally Benchling and LabVantage, structured data models, digital interfaces, and automation-enabled laboratory workflows.
• Track record improving laboratory productivity, turnaround time, right-first-time performance, and resource utilization while maintaining reliable delivery and high-quality data.
• Proven people leadership through managers, including hiring, feedback, performance differentiation, coaching, staff development, succession, and retention.
• Executive communication and influence across Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, QC/QA, Regulatory CMC, and Digital, aligned with Moderna’s values of Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Lead the Core Analytical Testing & Integrations organization, setting strategy, capacity plans, execution standards, and continuous-improvement priorities while safeguarding program commitments.
• Lead approximately 30–50 scientists, analysts, managers, and integration specialists across analytical technology capabilities.
• Oversee primarily non-GMP analytical testing supporting process development, product characterization, non-GMP release and stability, manufacturing engineering runs, and PPQ-related development activities.
• Ensure analytical data are complete, accurate, reproducible, traceable, and filing-ready to support Module 3 regulatory submissions and Regulatory CMC data requests.
• Provide technical leadership across separations, RNA critical quality attributes, lipids, biophysical methods, compendial testing, molecular biology, sequencing, and microbiology, including bioburden and endotoxin testing.
• Maintain non-GMP release and stability execution across sample receipt, study planning, scheduling, data review, reporting, and delivery against commitments.
• Lead the Integrations team’s test and request intake, analyst and assay scheduling, capacity and batching, stability coordination, performance metrics, digital workflows, stakeholder engagement, cross-functional coordination, and issue escalation.
• Establish testing priorities, readiness expectations, and delivery commitments in partnership with Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, Quality, Regulatory CMC, and Digital/IT.
• Partner with QC and QA on phase-appropriate GMP testing for early-phase material release, including qualified analytical coverage, controls, governance, and records.
• Develop analytical method-performance monitoring for system suitability, variability, control trends, method drift, repeats, and atypical results; use findings to identify risk and guide method improvements and lifecycle decisions.
• Work with Analytical Development, Process Development, Science & Technology, and QC on method readiness, troubleshooting, and transfer between development testing and GMP QC execution.
• Establish operating dashboards for right-first-time performance, turnaround time, on-time delivery, backlog, capacity utilization, investigations, retests, method performance, and stability milestones; translate 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 rigor, data quality, or safety.
• Modernize Benchling, LabVantage LIMS, and related digital workflows, focusing on structured data, study and sample traceability, scheduling, and review, and reducing manual handoffs with Digital/IT.
• Explore appropriate use of Generative AI in laboratory and analytical operations for knowledge access, structured data interpretation, workflow efficiency, and scientific decision support, with appropriate controls, data integrity, and human oversight.
• Set expectations for quality, data integrity, training, and EHS, and maintain fit-for-purpose procedures, documentation, investigation, and escalation practices.
• Build a high-performing organization through workforce planning, manager coaching, performance management, goal setting, hiring, employee engagement, development, succession planning, and structured rotations.
• Strengthen leadership capabilities so managers can maintain day-to-day delivery while improving scientific, technical, and operational performance.
• Make risk-based cross-functional decisions about priorities, resources, and trade-offs while protecting delivery commitments and collaboration across CMC.
• Evolve the function, operating model, and digital systems without disrupting ongoing analytical work or compromising submission-critical execution.
• Perform additional duties as assigned.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs.
• Location-specific perks and extras.
• May be eligible for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director