Director, CMC Stability — Strategy & Lifecycle Leadership

Moderna; Norwood (KY); On-site; USD 167,000 - 301,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Generous paid time off

Job summary

Moderna seeks a Director, CMC Stability to lead end-to-end stability across non-clinical-enabling, clinical, and commercial programs at its Norwood, MA campus. You will translate target product profile expectations into robust stability strategies and design studies to support regulatory filings and lifecycle management.

You will build a high-performing stability team, drive data trending, expiry assessments, and stability reviews, and partner with Analytical Development, Quality, Regulatory

Qualifications

• Degree in Life Sciences or related field.
• 15 years of relevant experience with Bachelor's degree or 10 years with a PhD.

Responsibilities

• Lead end-to-end CMC Stability across non-clinical-enabling, clinical, and commercial programs.
• Translate TPP expectations into stability and shelf-life claims.
• Define scientifically robust stability study designs to support regulatory submissions and lifecycle management.
• Build and maintain stability governance, dashboards, and decision forums.
• Oversee stability data trending, expiry assessments, and stability reviews with cross-functional teams.
• Author and review stability sections for regulatory submissions and responses.

Skills

Stability strategy

Cross-functional leadership

Regulatory knowledge

Data interpretation

Education

Bachelor's degree in Life Sciences or related field

PhD preferred

Job description

Moderna seeks a Director, CMC Stability to lead end-to-end stability across non-clinical-enabling, clinical, and commercial programs at its Norwood, MA campus. You will translate target product profile expectations into robust stability strategies and design studies to support regulatory filings and lifecycle management.

You will build a high-performing stability team, drive data trending, expiry assessments, and stability reviews, and partner with Analytical Development, Quality, Regulatory