CMC Stability Lead Regulatory Submissions & Strategy

About 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. Location Moderna is strengthening its presence in Norwood, Massachusetts. The Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. Responsibilities 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. 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. Basic Qualifications Education: Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline. Experience: 10 years of relevant experience with a Bachelor’s degree or 2 years of relevant experience with a PhD. This position is site‑based, requiring full‑time presence at the Moderna site. Remote work is not eligible. Preferred Qualifications 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 high accountability. Experience with development and clinical programs, or with commercial lifecycle management, annual product quality review support, or expiry‑risk management, is preferred. Desire to make an impact as part of a high‑growth, transformational company. Pay & Benefits Best‑in‑class healthcare coverage, plus voluntary benefit programs to support your unique needs. A holistic approach to well‑being, with access to fitness, mindfulness, and mental health support. Family planning benefits, including fertility, adoption, and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown. Savings and investment opportunities to help you plan for the future. Location‑specific perks and extras. Salary Range $130,800.00 – $209,400.00. Salary within this range is based on qualifications, experience, and other factors. Eligible candidates may receive a discretionary bonus, incentive compensation, or equity award subject to company plans and performance. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E‑Verify Employer in the United States. Accommodations Moderna is committed to offering reasonable accommodations to qualified applicants with disabilities. Contact the Accommodations team at View email address on click.appcast.io if you require an accommodation in connection with the hiring process or to perform essential job functions. Export Control Notice This position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon the applicant’s ability to access export‑controlled information. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position; Moderna cannot sponsor non‑U.S. persons for an export control license. #J-18808-Ljbffr