Associate Director, Stability Lead Development & Clinical

Joining Moderna means advancing mRNA science to transform medicine. As a stability leader, you will define and execute phase-appropriate stability strategies across a diverse mRNA portfolio spanning development, clinical, and commercial products. You will operate as a cross-functional subject matter expert, translating complex stability data into actionable program, regulatory, and supply decisions. This role blends deep scientific expertise, statistical insight, and matrix leadership to ensure robust shelf-life strategies, regulatory success, and uninterrupted patient supply.

Responsibilities

Define and lead phase-appropriate stability strategies aligned to development, clinical, or commercial program objectives; Design and oversee stability protocols and study plans supporting IND/CTA submissions, pivotal readiness, registration-enabling packages, post-approval commitments, and commercial lifecycle initiatives; Ensure all stability strategies, studies, and outputs are aligned with ICH guidance, global regulatory expectations, and internal quality and compliance standards; Lead stability data review, including statistical evaluation and trending analysis, to support defensible shelf-life assignments, expiry updates, storage conditions, and risk-based recommendations; Identify emerging degradation trends, product risks, and supply vulnerabilities; Provide technical leadership in shelf-life modeling, provisional and long-term expiry dating, comparability assessments, storage condition evaluations, and change-impact assessments; Author and review stability sections for regulatory submissions and responses; Partner closely with Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams; Collaborate with Clinical Supply and Supply Chain to align expiry strategy, stability milestones, and inventory risk mitigation; Lead and support stability-related OOS/OOT investigations, formal risk assessments, and issue resolution; Contribute to annual product quality reviews, shelf-life reassessments, lifecycle management, and continuous improvement of stability processes, tools, and governance; Operate as an influential matrix leader; Leverage digital tools and advanced analytics, including opportunities to engage with emerging generative AI capabilities; Perform additional duties as required

Requirements

Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline; 12 years of relevant experience with Bachelor's degree or 5 years of relevant experience with a PhD; Eligibility to access export-controlled information as a U.S. person (citizen, permanent resident, asylee, or refugee)

Nice to have

Advanced degree in a relevant field is preferred combined with a 7+ years of relevant industry experience; Significant experience leading stability strategy for biologics, vaccines, or other complex drug products in either development/clinical or commercial settings; Demonstrated experience authoring stability content for major regulatory submissions and supporting health authority interactions; Experience operating within cross-functional CMC team structures; Experience in statistical analysis, stability trending, and scientific interpretation of complex data sets; Experience with development and clinical programs, or post-approval/commercial lifecycle management; Demonstrated ability to balance scientific rigor, regulatory compliance, and business or supply considerations in a fast-paced matrixed environment; Experience leading stability-related investigations, change assessments, and formal risk evaluations with cross-functional partners; Strong cross-functional leadership and influence skills; Demonstrated success driving process improvements, governance, or operating-model enhancements within a CMC or technical development organization; Excellent written and verbal communication skills; A desire to make an impact as part of a high-growth, transformational company

Benefits

Best-in-class healthcare coverage and voluntary benefit programs; 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 discretionary year-end shutdown; Savings and investment opportunities; Location-specific perks and extras; Eligibility for an annual discretionary bonus, other incentive compensation, or equity award