About this role
About the Role 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. What You'll Do
- Define and lead phase-appropriate stability strategies aligned to development, clinical, or commercial program objectives, ensuring strong scientific and regulatory positioning across the portfolio.
- 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, driving proactive, cross-functional mitigation strategies.
- 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 across clinical, registration, and post-approval stages.
- Partner closely with Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align stability strategies with program and business needs.
- Collaborate with Clinical Supply and Supply Chain to align expiry strategy, stability milestones, and inventory risk mitigation with evolving program timelines.
- Lead and support stability-related OOS/OOT investigations.