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

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.

Here’s What You’ll Need (Basic Qualifications):

• 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.

Here’s What You’ll Bring to the Table (Preffered Qualifications):

• 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.

Work Environment & Expectations

• This is an individual contributor position with high visibility and strategic impact.

• Role requires cross-functional engagement with Regulatory Affairs, Quality Control, Manufacturing and Technical Operations.

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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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