Director, Analytical Technical Operations

Moderna•Norwood, MA
•$167,000 - $300,700•Onsite

About The Position

Moderna is hiring a Director to lead its Core Analytical Testing & Integrations organization at its Norwood, Massachusetts campus. The organization comprises approximately 30–50 scientists, analysts, managers and integration specialists who generate controlled, reproducible, filing-ready analytical data supporting CMC development and Module 3 (Quality) regulatory submissions. The work is primarily conducted in a non-GMP environment, with oversight of non-GMP release, stability, engineering-run and PPQ-related development support, as well as 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 maintaining program commitments and submission-critical data quality. The role provides technical leadership across separations, RNA and lipid analytics, biophysical and compendial methods, molecular biology, sequencing and microbiology. It also oversees analytical testing operations, method-performance monitoring, laboratory efficiency, digital workflows and the connection between development analytical methods and GMP QC operations. The role requires close collaboration with Analytical Development, Process Development, CMC Stability, Manufacturing, MS&T, Quality, Regulatory CMC, QC, QA and Digital/IT. The Director will build a high-performing organization, coach managers, develop talent and succession plans, and make risk-based decisions about priorities, resources and trade-offs. The position is 100% onsite at the Norwood campus.

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.
  • Strong scientific judgment and broad technical fluency across analytical methods and capabilities relevant to the organization.
  • Ability to lead a large, multi-disciplinary organization and build leadership capabilities among managers.
  • Ability to communicate with and influence cross-functional stakeholders and make risk-based decisions.
  • The position is 100% onsite in Norwood, Massachusetts.
  • Eligibility as a U.S. person (citizen, permanent resident, asylee or refugee) is required for access to export-controlled information; Moderna states it cannot sponsor non-U.S. persons for an export control license.

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.
  • Demonstrated record 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 support 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.
  • Alignment 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 the organization’s analytical 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 complete, accurate, reproducible, traceable and filing-ready development analytical data supporting 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 reliable non-GMP release and stability execution from sample receipt and study planning through scheduling, data review, reporting and delivery against commitments.
  • Lead the Integrations team’s test and request intake, 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 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.
  • Establish analytical method-performance monitoring for system suitability, variability, control trends, method drift, repeats and atypical results; use findings to identify risk and inform improvements and lifecycle decisions.
  • Work with Analytical Development, Process Development, Science & Technology and QC on method readiness, troubleshooting and transfer, connecting development testing with 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, and act on emerging trends and constraints.
  • Improve 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, 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, maintaining fit-for-purpose procedures, documentation, investigations and escalation practices appropriate to each result’s intended use.
  • 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 on priorities, resources and trade-offs while protecting commitments and strengthening CMC collaboration.
  • 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.
  • Potential eligibility for an annual discretionary bonus, other incentive compensation or an equity award, subject to company plan eligibility criteria and individual performance.
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