Head of Analytical Development

Moderna is seeking a Head of Analytical Development to lead the Analytical Development organization, reporting to the SVP, CMC Development, and serving as a key member of the CMC Development leadership team. The leader will be accountable for the end-to-end analytical strategy, operating model, technical standards, organizational capability, and execution needed to advance Moderna programs from early development through late-stage development, commercialization, and lifecycle management. The role is 100% onsite in Norwood, Massachusetts.

Responsibilities

Lead the Analytical Development organization as the functional head, setting overall vision, strategy, priorities, operating model, technical standards, governance, resource agenda, and talent strategy; Own end-to-end 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 strategic and technical leadership across Analytical Development sub-functions, including Analytical Sciences, PhysChem method development, product characterization, microbiology, potency assurance / bioassay development, analytical program leadership, clinical stability, and analytical regulatory execution; Ensure phase-appropriate analytical method development, qualification, validation readiness, clinical method transfer, troubleshooting, continued clinical method performance monitoring, and lifecycle management for mRNA-based products and other advanced therapeutic modalities; Set analytical control strategies for programs, platforms, and synthetic raw materials, including specifications, CQA and potential CQA understanding, comparability strategy, reference material strategy, impurity/purity assessment, material qualification, shelf-life/retest strategy, and analytical risk management; Drive product, process, and material understanding through fit-for-purpose characterization strategies for RNA, LNP, drug product, DNA, enzymes, lipids, synthetic raw materials, and emerging modalities; Provide technical analytical leadership for 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 across Analytical Development and partner functions; Partner closely with CMC Product Leads, Process Development, ATO/AST, QC, Quality, Manufacturing, MS&T, Regulatory CMC, Supply Chain, Procurement, Legal/IP, and external partners; Ensure successful transfer and deployment of analytical methods into clinical testing, QC, manufacturing, and CDMO networks; Provide analytical technical leadership for investigations involving method performance, unexpected release or stability results, impurities, or comparability; Identify, evaluate, and implement new analytical technologies, automation, digital tools, high-throughput approaches, data science, and AI-enabled workflows; Represent Moderna externally through scientific conferences, technical forums, regulatory/scientific workshops, and industry consortia; Build and develop a high-performing leadership team, strengthening the team-lead layer and creating succession depth; 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, and continuous improvement

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 multi-disciplinary technical organizations and influencing across matrixed CMC organizations, including direct accountability for analytical strategy, method development, product characterization, technical transfer, regulatory support, external partner oversight, and lifecycle management; Willingness to relocate to/be based in the Norwood, MA area

Nice to have

Proven ability to lead an Analytical Development function at enterprise scale, with accountability for strategy, execution, organizational design, governance, talent development, resource planning, and cross-functional delivery; Deep scientific and technical expertise across multiple 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 analytical technologies; Strong understanding of CMC development from early clinical through commercialization, including phase-appropriate analytical expectations, method lifecycle, analytical control strategy, specifications, comparability, and global regulatory submission requirements; Demonstrated leadership in establishing analytical playbooks, platform methods, technical standards, governance forums, risk frameworks, and decision-making mechanisms; Demonstrated success partnering with QC, ATO/AST, Quality, Process Development, Manufacturing, MS&T, Supply Chain, Regulatory CMC, Procurement, Legal/IP, program leadership, and external CDMO/testing partners; Demonstrated 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, including representing an organization at conferences, technical forums, regulatory or scientific workshops, and industry consortia; Strong record of building leadership benches, mentoring senior scientists and people leaders, managing complex organizational change, and creating clear growth pathways; Ability to make clear, risk-based decisions in ambiguous situations and communicate complex analytical strategies to technical, executive, and cross-functional audiences; Experience advancing analytical innovation, automation, digital systems, data science, AI-enabled workflows, and high-throughput analytical approaches; Excellent communication, stakeholder management, enterprise leadership, and organizational influence skills

Benefits

Competitive healthcare, plus voluntary benefit programs; Holistic well-being approach with access to 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 investments to help plan for the future; Location-specific perks and extras; Eligibility for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance