Director, CMC Stability

The Role

CMC is seeking a dynamic and experienced Director CMC Stability to lead an end-to-end stability function spanning non-clinical-enabling clinical and commercial programs. This leader will translate target product profile (TPP) expectations into scientifically robust stability and shelf-life strategies design stability studies that demonstrate those claims and ensure stability data are generated interpreted and communicated in ways that enable timely CMC decisions regulatory filings and product lifecycle management. This is an onsite role based in Modernas Technology Center campus in Norwood MA.

In this role you will lead a high-performing stability team responsible for portfolio stability strategy study design capacity planning data trending and expiry assessment stability reviews stability forecasting submission authoring and responses to health authority questions. You will be accountable for ensuring stability strategy is integrated into product team milestones and that program teams have clear decision-grade stability updates at the moments that matter.

To be successful you will bring strong CMC judgment deep stability science and the ability to make practical trade-off decisions in a fast-paced matrixed environment. You will help teams evaluate deviations excursions out-of-trend signals capacity constraints shelf-life optionality and prioritization decisions with clear understanding of compliance supply patient and regulatory implications. You are an execution-oriented leader who can establish effective operating models develop talent and influence across Analytical Development Quality Regulatory CMC Manufacturing MS&T Clinical Supply Commercial Supply and product teams.

Heres What Youll Do

• Lead the end-to-end CMC Stability function across non-clinical-enabling clinical and commercial programs ensuring stability strategies are aligned with product goals CMC strategy regulatory expectations and supply needs.
• Translate target product profile (TPP) expectations into required stability and shelf-life claims including storage condition in-use shipping handling excursion and lifecycle flexibility needs.
• Define and oversee scientifically robust stability study designs that demonstrate claims are met and support clinical advancement regulatory approvals commercial launch and post-approval lifecycle management.
• Build and maintain effective stability operating models governance and decision forums that clarify product team accountability critical milestones stability deliverables and escalation pathways.
• Drive effective utilization of stability capacity to enable shelf-life flexibility regulatory optionality lifecycle commitments comparability assessments and strategic portfolio prioritization.
• In partnership with Quantitative Sciences oversee stability data trending statistical analysis expiry assessments and stability reviews to identify emerging risks inform shelf-life decisions and enable clear cross-functional action plans.
• Provide technical leadership for out-of-trend investigations atypical stability observations temperature excursions shipping excursions deviations comparability questions and product risk assessments.
• Make and influence risk-based decisions on prioritization and trade-offs across stability studies sample pulls testing capacity data package timing regulatory commitments and supply continuity.
• Partner with Quantitative Sciences Analytical Development Quality Control Quality Assurance Regulatory CMC Manufacturing MS&T Clinical Supply Commercial Supply and program teams to ensure stability plans are executable and integrated with broader CMC control strategies.
• Oversee authoring and review of stability sections for regulatory submissions briefing packages annual reports post-approval supplements and responses to health authority questions including relevant RTQs.
• Establish portfolio-level stability forecasting dashboards and metrics including study start readiness pull/test cadence turnaround time backlog protocol/report cycle time and regulatory commitment tracking.
• Develop mentor and lead a high-performing team of stability leads and associates fostering a culture of scientific rigor accountability compliance collaboration and continuous improvement.

Heres What Youll Need (Basic Qualifications)

• Education: Degree in Life Sciences Chemistry Biochemistry Pharmaceutical Sciences Chemical Engineering Bioengineering or related technical discipline
• Experience: 15 years of relevant experience with Bachelors degree or 10 years of relevant experience with a PhD

Heres What Youll Bring to the Table (Preferred Qualifications)

• PhD in a relevant scientific or engineering discipline is preferred.
• Deep expertise in stability strategy and execution across development registration commercial launch and lifecycle management for biologics vaccines mRNA/nucleic acid-based therapeutics drug products or other complex modalities.
• Strong knowledge of global stability expectations and guidance including ICH Q1AQ1E accelerated and long-term stability design statistical shelf-life assessment bracketing/matrixing concepts and post-approval stability commitments.
• Demonstrated ability to translate product patient supply and regulatory needs into executable stability strategies shelf-life claims storage conditions and risk-based evidence packages.
• Experience authoring or contributing to IND/CTA/BLA/MAA stability sections health authority responses RTQs annual reports post-approval supplements and regulatory commitment management.
• Strong technical judgment in stability data interpretation trend analysis expiry assignment out-of-trend investigations temperature excursions deviations comparability assessments and product risk management.
• Experience developing and operationalizing stability workflows governance models dashboards capacity forecasts and metrics that improve transparency prioritization cycle time quality and decision-making.
• Proven track record leading cross-functional teams and influencing stakeholders across Analytical Development QC QA Regulatory CMC Manufacturing MS&T Clinical Supply Commercial Supply and product teams.
• Strong people leadership experience including hiring developing coaching and performance management of technical staff in a matrixed environment.
• Excellent communication executive presence and stakeholder management skills with the ability to communicate complex stability risks and trade-offs clearly to technical and non-technical audiences.
• Ability to operate strategically while driving detailed execution in a fast-paced environment with a commitment to scientific rigor compliance continuous improvement and Modernas values of 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 $167000.00 - $300700.00. 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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