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

Responsibilities

• Lead the design and execution of analytical qualification and validation strategies for late-phase and commercial programs
• Contribute to method transfer strategies in collaboration with internal and external partners across the global manufacturing network
• Author, maintain, and oversee Validation Master Plans to ensure compliance and product lifecycle considerations
• Define and manage commercial method lifecycle strategies, including distribution and continuous improvement
• Support the preparation of analytical sections for regulatory filings (BLA, MAA) to support product approvals
• Lead the preparation and execution of responses to regulatory queries and post-approval commitments

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
• Ability to work onsite full-time at the Norwood, MA location

Preferred 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

Benefits

• Best-in-class healthcare coverage and voluntary benefit programs
• Holistic well-being support including fitness, mindfulness, and mental health resources
• Family planning benefits including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, sabbatical, and global recharge days
• Savings and investment opportunities

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). Since our founding in 2010, we have aspired to build the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered. We are dedicated to delivering transformative science to patients and building a culture of belonging and innovation.