Sr. Manager, CMC Stability Lead

Moderna

Norwood Massachusetts Onsite Cmc & Development IPO

About this role

The Role

We are seeking a strong scientific and operational stability leader to support stability strategy execution across Moderna’s portfolio. This role will contribute to the design and management of stability studies, interpretation of stability data, shelf-life recommendations, and regulatory support for assigned development, clinical, or commercial programs to help advance programs, maintain compliant product control strategies, and support uninterrupted supply. This is an onsite role based in Moderna’s Technology Center campus in Norwood, MA.

In this role, you will work as a program-facing stability lead who partners closely with cross-functional teams to translate stability data into clear, actionable decisions. You will help design studies, evaluate trends, support shelf-life assignments, prepare regulatory content, and drive timely resolution of stability-related issues within either a development/clinical or commercial scope, depending on business need. You will be expected to operate with strong scientific judgment and increasing independence while collaborating effectively across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams, as relevant to your assigned programs.

Here’s What You’ll Do

· Define and execute stability strategies for assigned development, clinical, or commercial programs in alignment with program goals, regulatory expectations, and business needs.

· Design stability protocols and study plans to support clinical progression, registration activities, commercial maintenance, or selected lifecycle management initiatives, as applicable to assigned programs.

· 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, as relevant to assigned programs.

· Author and contribute to stability sections for regulatory submissions, responses, and technical documentation, including clinical, registration, and post-approval materials, as applicable.

· Partner with Clinical Supply, Supply Chain, and other stakeholders to help manage stability milestones, inventory risk, and expiry-related planning.

· Lead or support investigations for stability-related OOS/OOT events and partner with Quality to ensure timely, compliant resolution.

· Maintain high standards of data integrity, documentation quality, and inspection readiness for stability-related records and deliverables.

· Collaborate across cross-functional CMC teams to align study execution, issue management, and decision-making with broader program priorities.

· Identify and implement opportunities to improve stability processes, tracking, reporting, and team effectiveness.

· Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Basic 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.

Here’s What You’ll 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. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

Competitive healthcare, 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 investments to help you plan for the future
Location-specific perks and extras

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. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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 modernatx.com/careers 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 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. Moderna 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

We’re 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 leavesandaccommodations@modernatx.com. 

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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-SB2