Head of Analytical Development

ModernaTX • Norwood, MA

2d • Onsite

About The Position

Moderna is seeking a Head of Analytical Development to lead the Analytical Development organization and serve as a key member of the CMC Development leadership team, reporting to the SVP, CMC Development. The role owns the organization’s end-to-end analytical strategy, operating model, technical standards, governance, resources, talent strategy, and execution across the product lifecycle, from early development through late-stage development, commercialization, and lifecycle management.

The leader provides scientific, technical, organizational, and talent leadership across analytical method development, product characterization, analytical control strategy, microbiology, potency and bioassay strategy and development, analytical program leadership, technical transfer, and regulatory execution. The role requires setting enterprise direction, translating portfolio strategy into phase-appropriate priorities, making risk-based decisions, and aligning teams and external partners across the CMC organization. It also represents Moderna externally in selected scientific and industry forums, brings external insights into the company’s strategy and capability roadmap, and builds leadership depth and organizational capability.

This is a 100% onsite role based in or near Norwood, Massachusetts. The position may involve access to technology or data subject to U.S. export control laws; access to such information must comply with applicable U.S. law.

Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemical Engineering, or a related scientific discipline.
• 18+ years of relevant industry experience, including significant executive-level leadership experience in analytical development for biologics, vaccines, nucleic-acid-based medicines, or other advanced therapeutic modalities.
• Demonstrated experience leading multidisciplinary technical organizations and influencing across matrixed CMC organizations.
• Direct accountability for analytical strategy, method development, product characterization, technical transfer, regulatory support, external partner oversight, and lifecycle management.
• Willingness to relocate to or be based in the Norwood, Massachusetts area.

Nice To Haves

• Experience leading an Analytical Development function at enterprise scale, including strategy, execution, organizational design, governance, talent development, resource planning, and cross-functional delivery.
• Deep expertise across analytical development domains relevant to mRNA and advanced modality products, including separation sciences, nucleic acid analytics, LNP and particle characterization, residual impurity testing, compendial methods, bioassays, potency, microbiological methods, reference materials, synthetic raw material analytics, impurity characterization, and emerging technologies.
• Strong understanding of CMC development from early clinical development through commercialization, including phase-appropriate analytical expectations, method lifecycle, control strategy, specifications, comparability, and global regulatory submission requirements.
• Experience establishing analytical playbooks, platform methods, technical standards, governance forums, risk frameworks, and decision-making mechanisms that improve portfolio-wide speed, consistency, and quality.
• Success partnering with QC, ATO/AST, Quality, Process Development, Manufacturing, MS&T, Supply Chain, Regulatory CMC, Procurement, Legal/IP, program leadership, and external CDMO and testing partners.
• Leadership of analytical strategy and deliverables for IND/IMPD and BLA/MAA submissions, health authority interactions, and post-approval lifecycle management.
• Strong external scientific presence and influence through conferences, technical forums, regulatory or scientific workshops, and industry consortia; ability to shape standards, benchmark practices, and apply external innovation internally.
• Record of building leadership benches, mentoring senior scientists and people leaders, managing organizational change, and creating growth pathways for technical and managerial talent.
• Ability to make clear, risk-based decisions in ambiguous situations, balance speed with scientific and regulatory rigor, and communicate complex strategies to technical, executive, and cross-functional audiences.
• Experience advancing analytical innovation, automation, digital systems, data science, AI-enabled workflows, high-throughput approaches, and platform scalability.
• Excellent communication, stakeholder management, enterprise leadership, and organizational influence skills, including leading through direct authority and matrixed accountability.
• Competencies include setting strategy; executing for results; leading teams; building relationships and influence; and driving sustainability.

Responsibilities

• Lead the Analytical Development organization and set its vision, strategy, priorities, operating model, technical standards, governance, resource agenda, and talent strategy.
• Own analytical development strategy across the product lifecycle, including early development, pivotal-enabling and late-stage development, PPQ/BLA-enabling activities, commercialization, post-approval changes, and lifecycle management.
• Provide leadership across Analytical Sciences, PhysChem method development, product characterization, microbiology, potency assurance and bioassay development, analytical program leadership, clinical stability, and analytical regulatory execution.
• Ensure phase-appropriate analytical method development, qualification, validation readiness, clinical method transfer, troubleshooting, performance monitoring, and lifecycle management for mRNA products and other advanced therapeutic modalities.
• Set analytical control strategies for programs, platforms, and synthetic raw materials, including specifications, quality attribute understanding, comparability, reference materials, impurity and purity assessment, material qualification, shelf-life and retest strategy, and analytical risk management.
• Drive fit-for-purpose characterization of RNA, LNP, drug product, DNA, enzymes, lipids, synthetic raw materials, and emerging modalities to support process development, comparability, regulatory filings, and lifecycle decisions.
• Lead analytical regulatory strategy and execution, including analytical sections of IND/IMPD/BLA/MAA submissions, comparability protocols and reports, specification justifications, stability packages, impurity justifications, briefing books, and responses to health authority questions.
• Establish governance forums, decision frameworks, risk escalation pathways, and ways of working that clarify ownership and improve the speed, quality, and consistency of technical decisions.
• Partner with CMC Product Leads and teams across Process Development, ATO/AST, QC, Quality, Manufacturing, MS&T, Regulatory CMC, Supply Chain, Procurement, Legal/IP, and external partners to align priorities, resources, timelines, risks, and deliverables.
• Ensure successful transfer and deployment of analytical methods into clinical testing, QC, manufacturing, and CDMO networks, including method readiness, transfer packages, control strategy, network harmonization, and inspection readiness.
• Provide analytical technical leadership for investigations involving method performance, unexpected release or stability results, impurities, or comparability.
• Identify, evaluate, and implement analytical technologies, automation, digital tools, high-throughput approaches, data science, and AI-enabled workflows to improve robustness, understanding, speed, scalability, knowledge management, and productivity.
• Represent Moderna at scientific conferences, technical forums, regulatory and scientific workshops, and industry consortia; build networks, benchmark practices, and translate external insights into internal strategy and capability development.
• Build and develop a high-performing leadership team by strengthening team-lead capacity, clarifying accountabilities, coaching emerging leaders, creating succession depth, and developing critical technical capabilities.
• Manage functional resourcing, portfolio prioritization, budget tradeoffs, workforce planning, external spend, and organizational capability building.
• Foster scientific excellence, accountability, collaboration, enterprise thinking, regulatory rigor, continuous improvement, and Moderna’s values: Bold, Relentless, Curious, and Collaborative.

Benefits

• Competitive healthcare and voluntary benefit programs.
• Well-being resources, including fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous 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 plan eligibility and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree