Sr. Manager, CMC Stability Lead

We are seeking a strong scientific and operational stability leader to support stability strategy execution across Moderna’s portfolio. This onsite role, based at our Technology Center campus in Norwood, MA, 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.

About the role

As a program-facing stability lead, you will partner 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. This role requires strong scientific judgment and collaboration across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams.

Responsibilities

• 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 lifecycle management initiatives.
• 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, including clinical, registration, and post-approval materials.
• Partner with Clinical Supply, Supply Chain, and other stakeholders to 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.
• Perform additional duties as assigned.

Requirements

• Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or a related technical discipline.
• 10 years of relevant experience with a Bachelor’s degree or 2 years of relevant experience with a PhD.

Qualifications

• Advanced degree in a relevant field preferred, combined with 4+ years of relevant industry experience.
• Experience supporting stability programs for biologics, vaccines, or other complex drug products in 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, 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 values being Bold, Relentless, Curious, and Collaborative.

Pay

The salary range for this role is $130,800.00 - $209,400.00. An individual’s position within the salary range will be based on factors including competencies, education, qualifications, certifications, experience, skills, performance, and business needs. The successful candidate may also be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support unique needs.
• Holistic well-being support, including fitness, mindfulness, and mental health resources.
• 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 programs to help plan for the future.
• Location-specific perks and extras.

Schedule

This is an onsite role following a 70/30 work model, with 70% in-office collaboration to foster innovation, teamwork, and mentorship.