Director, CMC Stability

Moderna Therapeutics; Norwood (MA); On-site; USD 167,000 - 300,700; Full time

Benefits offered by this job

Competitive healthcare benefits

Generous paid time off

Annual bonus and equity opportunities

Job summary

Moderna Therapeutics in Norwood, MA is seeking a Director, CMC Stability to lead end-to-end stability across non-clinical enabling, clinical and commercial programs. You will translate TPP expectations into robust stability and shelf-life strategies, design studies, and ensure data support regulatory filings and lifecycle management.

You will build a high-performing stability team, implement governance, and partner across Analytical Development, QC, QA, Regulatory CMC, Manufacturing, MS&T,

Qualifications

• Experience leading CMC stability programs across development and lifecycle.
• Strong leadership, executive presence, and stakeholder management.
• Deep knowledge of stability strategy, ICH guidelines, and regulatory expectations.

Responsibilities

• Lead end-to-end CMC Stability across non-clinical, clinical, and commercial programs.
• Translate TPP into stability and shelf-life claims; design studies.
• Oversee stability data trending, forecasting, and regulatory submissions.
• Build governance, dashboards, and capacity planning for stability.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Communication

Regulatory awareness

Education

Bachelor's degree in Life Sciences or related

PhD preferred

Tools

Statistical analysis

Job description

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 Moderna’s 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 matters. 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.

Here’s What You’ll 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.

Here’s What You’ll 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 Bachelor’s degree or 10 years of relevant experience with a PhD.

Here’s What You’ll 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 Q1A–Q1E, 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 Moderna’s values of Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

• 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 $167,000.00 - $300,700.00. 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.

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.

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 [e-mail].

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.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from these resumes.