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

Role Summary

Senior Manager – Analytical Sciences & Technology (AS&T) – CMC Lead at Moderna's Norwood, MA site. Provides technical expertise and program support for analytical method activities supporting late-phase development and commercial programs. Oversees qualification, validation, transfer, and lifecycle strategies for analytical methods across a global network. Strong background in regulatory submissions, analytical sciences, and method validation with experience in late-stage and commercial product support.

Responsibilities

• Late-Phase & Commercial Program Strategy
  • 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.
• Method Transfer Leadership
  • 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.
• Validation Master Plan Ownership
  • Author, maintain, and oversee Validation Master Plans, ensuring they reflect program needs, compliance requirements, and product lifecycle considerations.
• Analytical Method Lifecycle Management
  • Define and manage commercial method lifecycle strategy, including distribution, governance, and continuous improvement across the manufacturing network.
• Regulatory Submission Support
  • Support the preparation of analytical sections for regulatory filings related to late-phase and commercial programs to support product approvals and lifecycle maintenance.
• Regulatory Commitments & Queries
  • 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

• Required: Bachelor‚Äôs degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
• Required: 8+ years in Analytical Development, Quality Control, or related biopharma functions
• Required: Strong expertise in analytical method qualification, validation, and lifecycle management in late-phase and commercial settings
• Required: Experience with regulatory submissions (e.g., BLA, MAA) and interactions with global health authorities
• Required: Knowledge of ICH guidelines, GMP regulations, and industry best practices
• Required: Excellent technical writing skills for regulatory documentation
• Required: Strong collaboration, communication, and influencing skills across cross-functional and global teams
• Required: Site-based role at Moderna; not eligible for remote work

Skills

• Regulatory documentation and submission preparation
• Analytical method qualification, validation, and lifecycle management
• Cross-functional collaboration and program leadership
• Regulatory affairs engagement and query responses

Education

• Bachelor‚Äôs degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
• Preferred: Advanced degree (M.S. or Ph.D.)

Additional Requirements

• Some domestic and international travel may be required to support site transfers and regulatory engagements