Associate Director, Stability Lead Development & Clinical
Listed on 2026-07-02
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Business
Regulatory Compliance Specialist
The Role
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.
As a stability leader, you will define and execute phase-appropriate stability strategies across a diverse mRNA portfolio spanning development, clinical, and commercial products.
You will operate as a cross-functional subject matter expert, translating complex stability data into actionable program, regulatory, and supply decisions.
This role blends deep scientific expertise, statistical insight, and matrix leadership to ensure robust shelf-life strategies, regulatory success, and uninterrupted patient supply.
Here’s What You’ll DoDefine 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.
Perform additional duties as required to support evolving business and portfolio needs.
The key Moderna Mindsets you’ll need to succeed in the roleWe act with dynamic range, driving strategy and execution at the same time at every step.
We pivot fearlessly in the face of new data.
Here’s What You’ll Need (Basic Qualifications)- Education:
Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline - Experience:
12 years of relevant experience with Bachelor’s degree or 5 years of relevant experience with a PhD.
What You’ll Bring to the Table (Preferred Qualifications)
- Advanced degree in a relevant field is preferred combined with a 7+ years of relevant industry experience
- Significant experience leading stability strategy for biologics, vaccines, or other…
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