Director, CMC Stability - Strategy & Execution Leader

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

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning benefits

Generous paid time off

Job summary

Moderna seeks a Director, CMC Stability to lead an end-to-end stability function across non-clinical-enabling, clinical, and commercial programs. You will translate target product profile expectations into scientifically robust stability strategies, design studies, and ensure data are available for CMC decisions, regulatory filings, and lifecycle management.

You will guide a high-performing stability team, integrate stability plans with product milestones, and partner with Regulatory CMC, QA,

Qualifications

• 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

Responsibilities

• 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 TPP expectations into required stability and shelf-life claims, including storage condition, in-use, shipping, handling, excursion, and lifecycle flexibility needs.
• Define and oversee stability study designs that demonstrate claims are met and support clinical advancement, regulatory approvals, commercial launch, and lifecycle management.
• Build and maintain stability operating models, governance, and decision forums clarifying product team accountability and milestones.
• Drive stability capacity utilization to enable shelf-life flexibility, regulatory optionality, and portfolio prioritization.
• Oversee stability data trending, statistical analysis, expiry assessments, and stability reviews to identify risks and enable action plans.
• Provide technical leadership for out-of-trend investigations, temperature excursions, deviations, and product risk assessments.
• Make and influence risk-based decisions on prioritization across stability studies, data packages, and regulatory commitments.
• Partner with cross-functional teams to ensure stability plans are executable and integrated with broader CMC strategies.
• Oversee authoring of stability sections for regulatory submissions and responses to health authorities.
• Establish portfolio-level stability forecasting, dashboards, and metrics.
• Develop, mentor, and lead a high-performing team of stability leads and associates.

Education

Bachelor’s degree in Life Sciences or related field

PhD in a relevant scientific or engineering discipline

Job description

Moderna seeks a Director, CMC Stability to lead an end-to-end stability function across non-clinical-enabling, clinical, and commercial programs. You will translate target product profile expectations into scientifically robust stability strategies, design studies, and ensure data are available for CMC decisions, regulatory filings, and lifecycle management.

You will guide a high-performing stability team, integrate stability plans with product milestones, and partner with Regulatory CMC, QA,