Director, Analytical Development

Moderna • Norwood, MA

4d • $167,000 - $300,700 • Onsite

About The Position

In this role, you will lead the Innovative Technology and Methodology capability within Analytical Development and report to the Head of Analytical Development. You will set and execute the strategy for next-generation analytical methods and technologies, translating emerging scientific capabilities into robust, scalable, and sustainable solutions across the Quality Control network. Success in this role requires the ability to connect scientific innovation with product and control-strategy needs, operational realities, regulatory expectations, and measurable business value. You will partner closely with Analytical Sciences, Analytical Product Leads (APLs), Analytical Sciences & Technology (AST), Quality Control (QC), and other CMC functions to build an end-to-end pathway from technology identification and proof of concept through method development, transfer, implementation, and lifecycle adoption.

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or a related scientific field with 12+ years of relevant industry experience, or M.S. or B.S. with 18+ years of relevant experience in analytical development, analytical technology, pharmaceutical sciences, or related areas for biologics, vaccines, or advanced therapeutic modalities.

Nice To Haves

• Demonstrated ability to define and execute an analytical innovation or technology strategy and to translate emerging science into methods and capabilities that are adopted in development and/or GMP Quality Control environments.
• Deep scientific expertise in analytical method development with broad understanding across multiple analytical domains and the ability to assess the strengths, limitations, and intended-use suitability of emerging technologies.
• Strong understanding of analytical procedure lifecycle principles, including analytical target profiles, robustness and risk assessment, qualification/validation, method transfer, continued performance monitoring, and lifecycle change management; practical knowledge of ICH Q14 and Q2(R2) is strongly preferred.
• Proven experience moving new analytical technologies from concept or proof of concept through implementation, including cross-functional alignment, technology transfer, validation strategy, change control, and adoption within clinical and/or commercial testing networks.
• Strong knowledge of GMP, data integrity, global regulatory expectations, and inspection readiness, with the scientific judgment to balance innovation, phase-appropriate development, compliance, and operational scalability.
• Experience with analytical automation, high-throughput workflows, digital integration, advanced data analysis, AI/ML-enabled analytical applications, or other laboratory-of-the-future capabilities is highly desirable.
• Experience with mRNA, nucleic acids, lipid nanoparticles, vaccines, biologics, or other advanced modalities is strongly preferred, together with an understanding of how analytical technologies support product characterization, control strategy, comparability, stability, and manufacturing.
• Demonstrated success leading complex, matrixed initiatives across Analytical Development, QC, AST/MS&T, Process Development, Manufacturing, Quality, Regulatory, Digital, and external partners, with the ability to influence senior stakeholders without relying solely on direct authority.
• Strong external orientation and ability to build productive collaborations with technology vendors, academic groups, consortia, CROs/CDMOs, and peer organizations to identify, evaluate, and accelerate high-value analytical innovation.
• Demonstrated success developing high-performing scientific talent and creating an environment where rigorous experimentation, learning, prioritization, and execution translate into scalable organizational capabilities.
• Excellent scientific communication, executive presence, stakeholder management, and organizational leadership skills, along with a desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Lead the Innovative Technology and Methodology capability within Analytical Development, establishing the vision, scientific strategy, portfolio, and roadmap for next-generation analytical methods and technologies across clinical and commercial products.
• Build and govern an end-to-end analytical innovation pipeline that identifies unmet analytical needs, evaluates emerging technologies, prioritizes opportunities, develops proof-of-concept solutions, and advances successful technologies through development, qualification or validation strategy, transfer, and implementation.
• Partner closely with Analytical Sciences, APLs, AST, and QC to translate product knowledge, control-strategy needs, method performance trends, investigations, and network pain points into prioritized innovation programs with clear analytical target profiles and intended-use requirements.
• Drive development and modernization of analytical methodologies across relevant scientific domains, including separation sciences, molecular and sequencing technologies, biophysical and spectroscopic methods, bioassays, microbiology, advanced characterization, and other emerging analytical platforms appropriate to mRNA and advanced therapeutic modalities.
• Lead method transformation across the QC network by enabling replacement, simplification, consolidation, and harmonization of legacy methods with more robust, higher-throughput, automation-ready, and scalable platform approaches where scientifically and regulatorily justified.
• Partner with AST, QC, ATO, Quality, Regulatory, Digital, and Automation teams to establish practical implementation pathways for innovative methods, including bridging, transfer, validation, change management, digital integration, training, and sustained method performance across internal and external testing sites.
• Embed science- and risk-based analytical development principles consistent with evolving global expectations, including ICH Q14 and Q2(R2), to ensure new methodologies are fit for intended purpose, appropriately robust, lifecycle-ready, and supported by a defensible regulatory strategy.
• Establish a strong external innovation network across instrument and technology vendors, biotechnology companies, academic collaborators, consortia, and other external partners; actively scout emerging capabilities and determine where external innovation can accelerate Moderna analytical strategy.
• Advance automation-, digital-, and data-enabled analytical methodologies in partnership with relevant functions, designing methods and workflows that reduce manual variability, improve data integrity and review efficiency, and enable scalable deployment across the analytical network.
• Define clear success measures and business cases for the innovation portfolio, including improvements in method robustness, invalid/OOS/OOT rates, turnaround time, throughput, labor intensity, cost, method harmonization, and successful network adoption; use these measures to prioritize investment and stop or redirect low-value efforts early.
• Develop, coach, and inspire scientific talent while creating a culture that combines curiosity and experimentation with disciplined execution, technical rigor, cross-functional accountability, and a strong focus on translating innovation into sustained organizational impact.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, 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 you plan for the future
• Location-specific perks and extras

What This Job Offers

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