Senior Analytical Scientist – Method Validation & Lifecycle

Moderna; Norwood (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Moderna in Norwood, MA seeks an analytical CMC professional to provide executional support for method validation, transfer, and lifecycle management across late-phase and commercial programs. You will coordinate cross-functional teams, prepare documentation, and help ensure regulatory readiness while operating in a GMP-regulated biopharma environment.

The role emphasizes executional support, coordination, and documentation with a strong technical background in analytical sciences and

Qualifications

• Bachelor's degree required in a scientific field.
• 3+ years of analytical development/quality control experience in biopharma.
• Experience with GMP-regulated analytical methods.
• Strong writing and collaboration skills.

Responsibilities

• Provide project management and coordination for analytical method activities across late-phase and commercial programs.
• Support method validation, transfer, verification, and lifecycle management to meet regulatory and program milestones.
• Coordinate with internal labs, external partners, and QA/CMC to resolve documentation gaps.
• Contribute to analytical method transfer activities including planning and protocol/report review.
• Author and revise analytical documentation (validation plans, reports, transfer docs).
• Support lifecycle management of commercial methods including change control and post-implementation actions.
• Compile and review analytical data packages for regulatory submissions and responses.
• Contribute to regulatory query responses with cross-functional coordination.
• Identify documentation or validation needs through gap assessments for late-phase and commercial programs.
• Maintain organized records and trackers for traceability and inspection readiness.

Skills

Analytical Development

Quality Control

Analytical Sciences

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field

Job description

Moderna in Norwood, MA seeks an analytical CMC professional to provide executional support for method validation, transfer, and lifecycle management across late-phase and commercial programs. You will coordinate cross-functional teams, prepare documentation, and help ensure regulatory readiness while operating in a GMP-regulated biopharma environment.

The role emphasizes executional support, coordination, and documentation with a strong technical background in analytical sciences and