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Moderna

Develops mRNA-based medicines for health

Head of Analytical Development

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeNorwood, MA, USA

About the Job

Requirements

  • A Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemical Engineering, or a related scientific discipline, with 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.
  • Demonstrated experience leading multidisciplinary 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 or be based in the Norwood, Massachusetts area.
  • 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 that improve speed, consistency, and quality across a broad development portfolio.
  • 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 to align technical strategy and execution across development and commercial networks.
  • 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 experience representing an organization in conferences, technical forums, regulatory or scientific workshops, and industry consortia; ability to shape external standards, benchmark best practices, and bring external innovation back into internal strategy.
  • Strong record of building leadership benches, mentoring senior scientists and people leaders, managing complex organizational change, and creating clear 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 analytical 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 to improve productivity and quality.
  • Excellent communication, stakeholder management, enterprise leadership, and organizational influence skills, with the ability to lead through both direct authority and matrixed accountability.
  • Ability to create and articulate an organization-wide vision, analyze data from varied sources to support decisions, develop innovative ideas, and balance change with realistic implementation plans.
  • Ability to set challenging goals, drive results with accountability, adapt to ambiguity, identify risks using data and input, and make transparent decisions in the organization's best interest.
  • Ability to attract and recruit talent, motivate teams, delegate effectively, manage performance, and develop others.
  • Ability to persevere through challenges, lead by example, seek feedback, and continuously improve.
  • Ability to build relationships, communicate persuasively, inspire trust, and support team success.
  • Commitment to sustainability and integrating economic, societal, and environmental factors into strategy and decision-making.

Responsibilities

  • Lead the Analytical Development organization as its functional head, setting the 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 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, 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, critical quality attribute and potential critical quality attribute understanding, comparability strategy, reference material strategy, impurity and purity assessment, material qualification, shelf-life and retest strategy, and analytical risk management.
  • Drive robust 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, ensuring characterization supports process development, comparability, regulatory filings, and lifecycle decisions.
  • 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 that create clear ownership across Analytical Development and partner functions while improving 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, and external partners to align priorities, resources, timelines, technical risks, intellectual property considerations, and program deliverables.
  • Ensure successful transfer and deployment of analytical methods into clinical testing, QC, manufacturing, and CDMO networks, with accountability for method readiness, transfer packages, control strategy, global network harmonization, and inspection readiness.
  • Provide analytical technical leadership for investigations involving method performance, unexpected release or stability results, impurities, or comparability, in partnership with QC, Quality, and Process Development.
  • Identify, evaluate, and implement new analytical technologies, automation, digital tools, high-throughput approaches, data science, and AI-enabled workflows to improve analytical robustness, process understanding, speed, scalability, knowledge management, and productivity.
  • Represent Moderna externally through scientific conferences, technical forums, regulatory and scientific workshops, and industry consortia; shape external dialogue, build strategic networks, benchmark emerging practices, and translate external learning into Moderna’s analytical strategy and capability roadmap.
  • Build and develop a high-performing leadership team, strengthen the team-lead layer, clarify accountabilities, coach emerging leaders, create succession depth, and build critical technical capabilities across analytical development.
  • Manage functional resourcing, portfolio prioritization, budget tradeoffs, workforce planning, external spend, and organizational capability building to ensure the function can meet sustained portfolio demand, strategic platform needs, and evolving business priorities.
  • Foster a culture of scientific excellence, accountability, collaboration, enterprise thinking, regulatory rigor, continuous improvement, and the company's stated values.
  • Integrate sustainability and profit considerations into long-term strategy, incorporate stakeholder viewpoints into decisions, develop sustainable innovations and business models, and set and pursue business and sustainability goals.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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