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

About 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.

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.

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

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

• 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

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

We believe an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.