Sr. Manager, CMC Stability Lead

The Role

We are seeking a strong scientific and operational stability leader to support stability strategy execution across Modernas 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 Modernas 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.

Heres What Youll 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.

Heres What Youll Need (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.

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 benefits and well-being resources are designed to support youat 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 $130800.00 - $209400.00. 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 individuals 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 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 .

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 applicants 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

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