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

Overview Moderna is seeking a Senior Manager – Analytical Sciences & Technology (AS&T) – CMC based at the Norwood, MA site. The Senior Manager, AS&T - CMC Lead will provide technical expertise and program support for analytical method activities that support late‑phase development and commercial programs. The individual will oversee qualification, validation, transfer, and lifecycle strategies for analytical methods across a global network. 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. 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. 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. 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; remote work is not eligible. 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. Work Environment & Expectations Individual contributor with high visibility and strategic impact. Cross‑functional engagement with Regulatory Affairs, Quality Control, Manufacturing, and Technical Operations. Domestic and international travel may be required to support site transfers and regulatory engagements. Pay & Benefits Salary range: $130,800.00 – $209,400.00. Includes potential discretionary bonus, incentive compensation, or equity award. Benefits include best‑in‑class healthcare coverage, voluntary benefit programs, holistic wellness resources, family planning benefits, generous paid time off, savings & investment opportunities, and location‑specific perks. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to any protected characteristic. Moderna is an E‑Verify Employer in the United States. Accommodations Moderna offers reasonable accommodations to qualified job applicants with disabilities. Applicants requiring an accommodation should contact the Accommodations team at View email address on click.appcast.io . #J-18808-Ljbffr Moderna