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

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.,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.,Author, maintain, and oversee Validation Master Plans, ensuring they reflect program needs, compliance requirements, and product lifecycle considerations.,Define and manage commercial method lifecycle strategy, including distribution, governance, and continuous improvement across the manufacturing network.,Support the preparation of analytical sections for regulatory filings related to late-phase and commercial programs to support product approvals and lifecycle maintenance.,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.

Advanced degree (M.S. or Ph.D.) in a relevant scientific discipline.,Strong expertise in analytical method qualification, validation, and lifecycle management in late-phase and commercial settings.,Proven experience with regulatory submissions (BLA, MAA, etc.) and direct interactions with global health authorities.,In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices.,Excellent technical writing skills and ability to author high-quality regulatory documentation.,Strong collaboration, communication, and influencing skills across cross-functional and global teams.,Experience supporting biologics, vaccines, or other complex modalities.,Prior experience managing global method transfers and a network of manufacturing/testing sites.,Experience in late-stage and commercial product support and lifecycle activities.

Advanced Degree (M.S. or Ph.D.)

Moderna provides comprehensive support for its employees and their families. While a specific list of benefits is not publicly available, the company emphasizes its commitment to the well-being of its team. Benefits include paid time off for volunteering and support for community career development.

Some domestic and international travel may be required to support site transfers and regulatory engagements.