Sr. Manager, CMC Stability

Joining Moderna means advancing mRNA science to transform medicine. As a stability leader in our Norwood campus, you will execute phase‑appropriate stability strategies for a diverse portfolio of mRNA programs across development, clinical, and commercial stages.

• Define and execute stability strategies for assigned programs, ensuring alignment with program goals, regulatory expectations, and business needs.
• Design stability protocols and study plans to support clinical progression, registration activities, commercial maintenance, and lifecycle management initiatives.
• Review and interpret stability data, perform trending analyses, and support statistical evaluations to identify product trends, risks, and opportunities.
• Generate and communicate recommendations for shelf‑life assignment, expiry updates, storage conditions, and stability risk mitigation.
• Support stability‑related input into formulation, process development, control strategy, and change‑management discussions.
• Author and contribute to stability sections for regulatory submissions, responses, and technical documentation across stages.
• Partner with Clinical Supply, Supply Chain, and cross‑functional stakeholders to manage stability milestones, inventory risk, and expiry‑related planning.
• Lead or support investigations for stability‑related OOS/OOT events, working closely with Quality to ensure timely and compliant resolution.
• Maintain high standards of data integrity, documentation quality, and inspection readiness for all stability‑related deliverables.
• Collaborate across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align study execution and decision‑making with broader program priorities.
• Identify and implement opportunities to improve stability processes, tracking, reporting, and overall team effectiveness.
• Leverage digital tools and advanced analytics, including emerging generative AI capabilities, to enhance data interpretation and decision‑making.
• Perform additional duties as required to support evolving portfolio and business needs.

"We act with dynamic range, driving strategy and execution at the same time at every step."

"We obsess over learning. We don’t have to be the smartest we have to learn the fastest."

• Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline.
• 10 years of relevant experience with a Bachelor’s degree or 2 years of relevant experience with a PhD.
• Site‑based position requiring full‑time presence at Moderna’s site (not eligible for remote work).

• Advanced degree in a relevant field combined with 4+ years of relevant industry experience.
• Experience supporting stability programs for biologics, vaccines, or other complex drug products in development/clinical or commercial settings.
• Experience authoring or contributing to stability sections for regulatory submissions and responses.
• Strong background in stability data interpretation, statistical analysis, and shelf‑life assessment.
• Experience working in cross‑functional CMC teams within a matrixed development or commercial environment.
• Familiarity with ICH stability guidance and global regulatory expectations related to expiry dating, storage conditions, and post‑approval commitments.
• Experience supporting stability‑related investigations, risk assessments, and change evaluations.
• Ability to communicate clearly, influence constructively, and manage multiple priorities in a fast‑paced environment.
• Strong organizational skills and a demonstrated ability to drive execution with a high degree of accountability.
• Experience with development and clinical programs, or with commercial lifecycle management, annual product quality review support, or expiry‑risk management is preferred.
• A desire to make an impact as part of a high‑growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

The salary range for…