Sr. Manager, CMC Stability

Description

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

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

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 across clinical, registration, and post-approval stages.

Partner with Clinical Supply, Supply Chain, and cross-functional stakeholders to manage stability milestones, inventory risk, and expiry-related planning.

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

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

Collaborate across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams to align study execution and decision-making with broader program priorities.

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.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
• 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.