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

ModernaTX • Norwood, MA

2d • Onsite

About The Position

The Role: 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 related 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. Here's What You’ll Do: 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.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
• 8+ years of experience in Analytical Development, Quality Control, or related functions within the biopharmaceutical industry.
• 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.
• This position is site-based, requiring you to be at Moderna’s site full-time.
• This position is not eligible for remote work.

Nice To Haves

• Advanced degree (M.S., Ph.D.) in a scientific discipline.
• Experience supporting biologics, vaccines, or other complex modalities.
• Prior experience in global method transfers and managing a network of manufacturing/testing sites.

Responsibilities

• 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.

Benefits

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees