Sr. Manager, CMC Stability

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.

As a stability leader, you will execute phase-appropriate stability strategies across a diverse portfolio of mRNA programs spanning development, clinical, and commercial stages.

You will act as a program-facing scientific expert, translating stability data into actionable insights that inform regulatory, supply, and lifecycle decisions.

Operating as an individual contributor, you will combine scientific rigor, operational execution, and cross-functional collaboration to ensure robust product control strategies and uninterrupted patient supply.

Define and execute stability strategies for assigned development, clinical, or commercial 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 as applicable.

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 based on available data.

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 clinical, registration, and post‑approval 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.

• Education:
  
  Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
• Experience:
  
  10 years of relevant experience with Bachelor’s degree or 2 years of relevant experience with a PhD.
• This position is site‑based, requiring you to be at Moderna’s site full‑time. This position is not eligible for remote work.

• Advanced degree in a relevant field is preferred combined with a 4+ years of relevant industry experience
• Experience supporting stability programs for biologics, vaccines, or other complex drug products in either 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…