Sr. Manager, CMC Stability

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. 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.

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 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 exposure to emerging generative AI capabilities, to enhance data interpretation and decision-making.
• Perform additional duties as required to support evolving portfolio and business needs.

Qualifications

• 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.
• 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 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.

Pay & Benefits

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
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

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

Working Model

We believe an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or 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.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.