Senior Manager, Analytical Science & Technology (AS&T)

Role Summary

Moderna is seeking a Senior Manager – Analytical Sciences & Technology (AS&T) – CMC based at their Norwood, MA site. The Senior Manager, AS&T - CMC Lead will provide technical expertise and program support for analytical method activities that support late-phase development and commercial programs. This individual contributor role will oversee qualification, validation, transfer, and lifecycle strategies for analytical methods across a global network. The ideal candidate will have a strong background in regulatory submissions, analytical sciences, and method validation, with proven experience in late-stage and commercial product support.

Responsibilities

• Late-Phase & Commercial Program Strategy: Lead the design and execution of analytical qualification and validation strategies for late-phase and commercial programs, ensuring alignment with regulatory expectations and industry best practices.
• Method Transfer Leadership: Contribute to method transfer strategies in collaboration with internal and external partners across the Norwood site and other testing locations, ensuring consistency, compliance, and readiness for commercial supply.
• Validation Master Plan Ownership: Author, maintain, and oversee Validation Master Plans, ensuring they reflect program needs, compliance requirements, and product lifecycle considerations.
• Analytical Method Lifecycle Management: Define and manage commercial method lifecycle strategy, including distribution, governance, and continuous improvement across the manufacturing network.
• Regulatory Submission Support: Support the preparation of analytical sections for regulatory filings related to late-phase and commercial programs to support product approvals and lifecycle maintenance.
• Regulatory Commitments & Queries: Lead the preparation and execution of responses to regulatory queries (RtQ) and post-approval commitments, ensuring timely, clear, and compliant communication with global health authorities.

Qualifications

• Required: 8+ years of experience in Analytical Development, Quality Control, or related functions within the biopharmaceutical industry.
• Required: Strong expertise in analytical method qualification, validation, and lifecycle management in late-phase and commercial settings.
• Required: Proven experience with regulatory submissions (BLA, MAA, etc.) and direct interactions with global health authorities.
• Required: In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.
• Required: Excellent technical writing skills and ability to author high-quality regulatory documentation.
• Required: Strong collaboration, communication, and influencing skills across cross-functional and global teams.
• Required: This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.
• Preferred: Advanced degree (M.S., Ph.D.) in a scientific discipline.
• Preferred: Experience supporting biologics, vaccines, or other complex modalities.
• Preferred: Prior experience in global method transfers and managing a network of manufacturing/testing sites.

Education

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.

Skills

• Analytical method development, qualification, validation, and lifecycle management
• Regulatory writing and documentation quality
• Cross-functional collaboration and influencing across global teams
• Communication and program execution in late-phase and commercial settings

Additional Requirements

• Site-based role requiring full-time presence at Moderna’s site; not eligible for remote work
• Some domestic and international travel may be required to support site transfers and regulatory engagements