Head of Analytical Development

Head of Analytical Development

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locations

Norwood, Massachusetts

Technical Development

time type

Full time

posted on

Posted Yesterday

job requisition id

R19933

The Role In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

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)

• Prov