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

Moderna

86d

About The Position

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.

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.

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 a suite of voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Lifestyle Spending Accounts to personalize your well-being journey.
• Family planning and adoption benefits.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees