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. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.

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.

Heres What Youll Do:

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.

The key Moderna Mindsets youll need to succeed in the role:

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

We obsess over learning. We dont have to be the smartest we have to learn the fastest.

Heres What Youll Bring to the Table (Basic Qualifications)

• Education: Degree in Life Sciences Chemistry Engineering Pharmaceutical Sciences or related technical discipline

• Experience: 10 years of relevant experience with Bachelors degree or 2 years of relevant experience with a PhD.

• This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

Heres What Youll Bring to the Table (Preferred Qualifications)

• 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

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• 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

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. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

As we build our company we have always believed 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. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at .

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