About this role
Director, CMC Stability
Location: Norwood, Massachusetts Technical Development, full time, posted today, requisition id R19494
The Role CMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non-clinical-enabling, clinical, and commercial programs. This leader will translate target product profile (TPP) expectations into scientifically robust stability and shelf-life strategies, design stability studies that demonstrate those claims, and ensure stability data are generated, interpreted, and communicated in ways that enable timely CMC decisions, regulatory filings, and product lifecycle management. This is an onsite role based in Moderna’s Technology Center campus in Norwood, MA.
In this role, you will lead a high-performing stability team responsible for portfolio stability strategy, study design, capacity planning, data trending and expiry assessment, stability reviews, stability forecasting, submission authoring, and responses to health authority questions. You will be accountable for ensuring stability strategy is integrated into product team milestones and that program teams have clear, decision-grade stability updates at the moments that matter.
To be successful, you will bring strong CMC judgment, deep stability science, and the ability to make practical trade-off decisions in a fast-paced, matrixed environment. You will help teams evaluate