Director, CMC Stability

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.

• Lead the end-to-end CMC Stability function across non-clinical-enabling, clinical, and commercial programs, ensuring stability strategies are aligned with product goals, CMC strategy, regulatory expectations, and supply needs.
• Translate target product profile (TPP) expectations into required stability and shelf-life claims, including storage condition, in-use, shipping, handling, excursion, and lifecycle flexibility needs.
• Define and oversee scientifically robust stability study designs that demonstrate claims are met and support clinical advancement, regulatory approvals, commercial launch, and post-approval lifecycle management.
• Build and maintain effective stability operating models, governance, and decision forums that clarify product team accountability, critical milestones, stability deliverables, and escalation pathways.
• Drive effective utilization of stability capacity to enable shelf-life flexibility, regulatory optionality, lifecycle commitments, comparability assessments, and strategic portfolio prioritization.
• In partnership with Quantitative Sciences, oversee stability data trending, statistical analysis, expiry assessments, and stability reviews to identify emerging risks, inform shelf-life decisions, and enable clear cross-functional action plans.
• Provide technical leadership for out-of-trend investigations, atypical stability observations, temperature excursions, shipping excursions, deviations, comparability questions, and product risk assessments.
• Make and influence risk-based decisions on prioritization and trade-offs across stability studies, sample pulls, testing capacity, data package timing, regulatory commitments, and supply continuity.
• Partner with Quantitative Sciences, Analytical Development, Quality Control, Quality Assurance, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and program teams to ensure stability plans are executable and integrated with broader CMC control strategies.
• Oversee authoring and review of stability sections for regulatory submissions, briefing packages, annual reports, post-approval supplements, and responses to health authority questions, including relevant RTQs.
• Establish portfolio-level stability forecasting, dashboards, and metrics, including study start readiness, pull/test cadence, turnaround time, backlog, protocol/report cycle time, and regulatory commitment tracking.
• Develop, mentor, and lead a high-performing team of stability leads and associates, fostering a culture of scientific rigor, accountability, compliance, collaboration, and continuous improvement.

• Education:
  
  Degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related technical discipline
• Experience:
  
  15 years of relevant experience with Bachelor’s degree or 10 years of relevant experience with a PhD

• PhD in a relevant scientific or engineering discipline is preferred.
• Deep expertise in stability strategy and execution across development, registration, commercial launch, and lifecycle management for biologics, vaccines, mRNA/nucleic acid-based therapeutics, drug products, or other complex modalities.
• Strong knowledge of global stability expectations and guidance, including ICH Q1A–Q1E, accelerated and long-term stability design, statistical shelf-life assessment, bracketing/matrixing concepts, and post-approval stability commitments.
• Demonstrated ability to…