Head of Analytical Development

The Role
Moderna is advancing a broad pipeline of mRNA medicines across respiratory vaccines, latent and other vaccines, oncology therapeutics, and rare disease therapeutics. Analytical Development plays a central role in enabling this portfolio by delivering robust analytical strategies, methods, characterization, control strategies, and regulatory-ready data packages across the product lifecycle.

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. This 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 incumbent will serve as the leader for Analytical Development, providing 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, analytical technical transfer, regulatory filings from IND/IMPD through BLA/MAA, and post-approval lifecycle management.

This role requires the ability to set enterprise direction, translate portfolio strategy into phase-appropriate technical priorities, make risk-based scientific and operational decisions, and align cross-functional partners across CMC Product Leadership, Process Development, ATO/AST, QC, Quality, Regulatory CMC, Manufacturing, MS&T, Supply Chain, Program Teams, and external CDMO and testing networks. Success requires building leadership depth across multiple sub-functions, establishing clear governance and decision rights, and ensuring that analytical data, methods, specifications, comparability approaches, and regulatory deliverables are scientifically rigorous, operationally executable, and globally inspection-ready.

The leader will also serve as a visible external scientific and technical voice for Moderna, representing the company in selective conferences, scientific forums, regulatory and industry workshops, and industry consortia to influence analytical practices; benchmark emerging technologies; and bring external insights back into Moderna’s strategy, capability roadmap, governance, and talent development.

Here’s What You’ll Do

• Lead the Analytical Development organization as the functional head, setting the overall vision, strategy, priorities, operating model, technical standards, governance, resource agenda, and talent strategy for the function.
• 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, critical quality attribute and potential critical quality attribute understanding, comparability strategy, reference material strategy, impurity / purity assessment, material qualification, shelf-life / 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 closely 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 clear 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/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, strengthening the team-lead layer, clarifying accountabilities, coaching emerging leaders, creating succession depth, and building 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 Moderna values: Bold, Relentless, Curious, and Collaborative.

Here’s What You’ll Bring to the Table (Basic Qualifications)

• Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemical Engineering, or a related scientific discipline with 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.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 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.

Competencies
In terms of the performance and personal competencies required for the position, we would highlight the following:

Setting Strategy

• The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the enterprise as a whole.
• The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
• The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.

Executing for Results

• The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.
• Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
• A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization.

Leading Teams

• The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.
• The ability to persevere in the face of challenges, and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.
• A leader who is self-reflective and aware of their own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.

Relationships and Influence

• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive.
• Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
• Creates a sense of purpose/meaning for the team that generates followership beyond their own perso