Stability Strategy Lead, Development & Clinical

Biopharma Careers; Norwood (KY); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Best-in-class healthcare

Well-being programs

Family planning benefits

Generous paid time off

Savings and investment opportunities

Location-specific perks

Job summary

Moderna is seeking a stability leader to define and execute phase-appropriate stability strategies across a diverse mRNA portfolio, spanning development, clinical, and commercial products. You will act as a cross-functional SME, translating stability data into actionable program, regulatory, and supply decisions.

You will collaborate across Analytical Development, Regulatory, Quality, and Clinical Supply to ensure robust shelf-life strategies, regulatory success, and uninterrupted patient

Qualifications

• Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
• Experience: 12 years with Bachelor’s or 5 years with a PhD
• Experience leading stability strategy for biologics, vaccines, or other complex drug products in development/clinical or commercial settings

Responsibilities

• Define and lead phase-appropriate stability strategies aligned to development, clinical, or commercial program objectives, ensuring strong scientific and regulatory positioning across the portfolio.
• Design and oversee stability protocols and study plans supporting IND/CTA submissions, pivotal readiness, registration-enabling packages, post-approval commitments, and commercial lifecycle initiatives.
• Ensure all stability strategies, studies, and outputs are aligned with ICH guidance, global regulatory expectations, and internal quality and compliance standards.
• Lead stability data review, including statistical evaluation and trending analysis, to support defensible shelf-life assignments, expiry updates, storage conditions, and risk-based recommendations.
• Identify emerging degradation trends, product risks, and supply vulnerabilities, driving proactive, cross-functional mitigation strategies.
• Provide technical leadership in shelf-life modeling, provisional and long-term expiry dating, comparability assessments, storage condition evaluations, and change-impact assessments.
• Author and review stability sections for regulatory submissions and responses across clinical, registration, and post-approval stages.
• Partner closely with Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align stability strategies with program and business needs.
• Collaborate with Clinical Supply and Supply Chain to align expiry strategy, stability milestones, and inventory risk mitigation with evolving program timelines.
• Lead and support stability-related OOS/OOT investigations, formal risk assessments, and issue resolution in partnership with Quality and cross-functional stakeholders.
• Contribute to annual product quality reviews, shelf-life reassessments, lifecycle management, and continuous improvement of stability processes, tools, and governance.
• Operate as an influential matrix leader, mentoring colleagues and guiding teams through complex technical decisions while fostering clarity, alignment, and execution.
• Leverage digital tools and advanced analytics, including opportunities to engage with emerging generative AI capabilities, to enhance stability insights, data interpretation, and decision-making.

Skills

Stability leadership

Cross-functional collaboration

Statistical analysis

Shelf-life modeling

Regulatory strategy

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline

PhD (preferred) or advanced degree

Job description

Moderna is seeking a stability leader to define and execute phase-appropriate stability strategies across a diverse mRNA portfolio, spanning development, clinical, and commercial products. You will act as a cross-functional SME, translating stability data into actionable program, regulatory, and supply decisions.

You will collaborate across Analytical Development, Regulatory, Quality, and Clinical Supply to ensure robust shelf-life strategies, regulatory success, and uninterrupted patient