CMC Stability Director: Strategy, Execution & Lifecycle

Moderna; Norwood (MA); On-site; USD 167,000 - 300,700; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Generous paid time off

Job summary

Moderna is seeking a Director, CMC Stability to lead an end-to-end stability function across non-clinical enabling, clinical, and commercial programs. You will translate TPP expectations into stability strategies, design robust studies, and ensure data supports CMC decisions and regulatory filings.

This onsite role is based at Moderna’s Technology Center campus in Norwood, MA. You will oversee a high-performing stability team, ensure lifecycle management, and collaborate with Regulatory CMC,

Qualifications

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

Responsibilities

• Lead end-to-end CMC Stability function across non-clinical enabling, clinical, and commercial programs; align stability with product goals and regulatory expectations.
• Design stability studies to demonstrate claims and support regulatory filings and lifecycle management.
• Build governance and decision forums for stability deliverables and escalation pathways.
• Oversee stability data trending, expiry assessments, and stability reviews to identify risks and enable cross-functional action plans.
• Author and review stability sections for regulatory submissions and post-approval commitments.
• Develop portfolio-level stability forecasting, dashboards, and metrics.

Skills

Stability leadership

CMC

Regulatory submissions

Cross-functional leadership

Data trending & analysis

Education

Bachelor’s degree in Life Sciences or related

PhD preferred

Job description

Moderna is seeking a Director, CMC Stability to lead an end-to-end stability function across non-clinical enabling, clinical, and commercial programs. You will translate TPP expectations into stability strategies, design robust studies, and ensure data supports CMC decisions and regulatory filings.

This onsite role is based at Moderna’s Technology Center campus in Norwood, MA. You will oversee a high-performing stability team, ensure lifecycle management, and collaborate with Regulatory CMC,