Director, CMC Stability

Role: Director, CMC Stability leading an end-to-end stability function for Moderna’s biopharmaceutical portfolio, including non-clinical, clinical, and commercial programs. Responsibilities: develop and execute stability strategies aligned with product profiles, design studies to support regulatory filings and lifecycle management, oversee stability data trending, risk assessments, and out-of-trend investigations. Collaborate across Analytical Development, Quality, Regulatory, Manufacturing, and Clinical teams; author regulatory stability sections, manage stability forecasts, dashboards, and metrics; lead a team of stability professionals, fostering scientific rigor and compliance. Requirements: Bachelor’s in Life Sciences, Chemistry, or related field with 15+ years of experience (or PhD with 10+ years), deep expertise in biologics, vaccines, mRNA modalities, and global stability standards (ICH Q1A–Q1E). Preferred: PhD, extensive stability strategy experience across development stages, proven ability to interpret stability data, and influence stakeholders. High-value: biologics, mRNA/nucleic acid therapeutics, vaccines, lifecycle stability, regulatory submissions, global stability guidance, GxP environment, leadership in a fast-paced, matrixed setting. WorkSetup: on-site in Norwood, MA, with a strong emphasis on leadership, collaboration, and scientific excellence.