Head of Analytical Development

Moderna • Norwood, MA

16h • $272,200 - $490,100 • Onsite

About The Position

Moderna is seeking a Head of Analytical Development to lead its Analytical Development organization and serve as a key member of the CMC Development leadership team. Reporting to the SVP, CMC Development, this leader will own the organization’s end-to-end analytical strategy, operating model, technical standards, governance, resourcing, talent strategy, and execution across the product lifecycle, from early development through commercialization and lifecycle management.

The role 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, regulatory execution, and post-approval lifecycle management. The leader will translate portfolio strategy into phase-appropriate technical priorities, make risk-based decisions, and align partners across CMC and external networks. They will ensure that analytical methods, data, specifications, comparability strategies, and regulatory deliverables are scientifically rigorous, operationally executable, and globally inspection-ready.

The Head of Analytical Development will build leadership depth and organizational capability, establish clear governance and decision rights, manage functional resources and portfolio priorities, and foster a culture of scientific excellence, accountability, collaboration, regulatory rigor, and continuous improvement. The role also represents Moderna externally at selected scientific and industry forums, bringing external insights into the company’s analytical strategy and capability roadmap.

The position is 100% onsite in the Norwood, Massachusetts area. The salary range is $272,200 to $490,100, and the successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or an equity award, subject to plan eligibility and individual performance.

Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemical Engineering, or a related scientific discipline.
• 18 or more 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.
• 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, with accountability for strategy, execution, organizational design, governance, talent development, resource planning, and cross-functional delivery.
• Deep technical expertise across analytical development domains relevant to mRNA and advanced modalities, 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 across 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, including representing an organization at conferences, technical forums, regulatory or scientific workshops, and industry consortia; ability to shape external standards, benchmark practices, and bring external innovation into internal strategy.
• 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 analytical approaches, and platform scalability.
• Excellent communication, stakeholder management, enterprise leadership, and organizational influence skills, including the ability to lead through direct authority and matrixed accountability.

Responsibilities

• Lead the Analytical Development organization, setting 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, late-stage and pivotal-enabling development, PPQ/BLA-enabling activities, commercialization, post-approval changes, and lifecycle management.
• Provide strategic and technical leadership across Analytical Sciences, physicochemical 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.
• 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 submission sections, 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, Process Development, ATO/AST, QC, Quality, Manufacturing, MS&T, Regulatory CMC, Supply Chain, Procurement, Legal/IP, program teams, 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 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.
• Represent Moderna at scientific conferences, technical forums, regulatory and scientific workshops, and industry consortia; build networks, benchmark practices, and bring external learning into internal strategy and capability development.
• Build and develop a high-performing leadership team, clarify accountabilities, coach emerging leaders, strengthen succession depth, and develop critical technical capabilities.
• Manage functional resourcing, portfolio prioritization, budget tradeoffs, workforce planning, external spend, and organizational capability building.
• Foster a culture of scientific excellence, accountability, collaboration, enterprise thinking, regulatory rigor, continuous improvement, and Moderna’s values of Bold, Relentless, Curious, and Collaborative.

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 plan eligibility criteria and individual performance.

What This Job Offers

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