Moderna · 1 day ago
Senior Manager, Analytical Science & Technology (AS&T)
Norwood, MA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $209K/yr
8+ years expModerna is a pioneering company in mRNA technology, and they are seeking a Senior Manager for Analytical Sciences & Technology to provide technical expertise for analytical method activities. The role involves overseeing qualification, validation, and lifecycle strategies for analytical methods to support late-phase development and commercial programs.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
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
Qualification
Required
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
Preferred
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, 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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-06
2025-12-30
Company data provided by crunchbase