CMC Analytics Coordinator: Method Validation & Lifecycle

Pharmacy500; Norwood (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Annual bonus potential

Equity award eligibility

Competitive healthcare

Job summary

Moderna is seeking an Analytical Development professional based at its Norwood, MA site to provide CMC executional support for method-related activities across late-phase development and commercial programs.

The role will contribute to analytical method validation, transfer, and lifecycle management activities in support of product development, regulatory submissions, and commercial readiness.

Qualifications

• Bachelor's degree in a relevant scientific field.
• 3+ years in Analytical Development, Quality Control, Analytical Sciences, or a related function in biopharmaceuticals.
• Experience supporting analytical method qualification, validation, transfer, and lifecycle management in GMP environments.
• Knowledge of ICH guidelines, GMP regulations, and industry best practices.
• Strong technical writing, documentation, and organizational skills.
• Ability to collaborate across cross-functional teams.

Responsibilities

• Provide project management and coordination for analytic method activities across late-phase development and commercial programs.
• Support planning, tracking, and follow-up for method validation, transfer, verification, and lifecycle management.
• Coordinate with internal labs, external testing partners, QA, Regulatory CMC, and program teams for timely execution and gap resolution.
• Contribute to analytical method transfer activities including planning, documentation, review, readiness, and follow-up on open items.
• Author and revise analytical docs including validation plans, protocols, reports, transfer docs, and memos.

Skills

Analytical Development

Quality Control

Analytical Sciences

Documentation

Cross-functional Collaboration

Technical Writing

Regulatory Submissions

GMP Knowledge

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Job description

Moderna is seeking an Analytical Development professional based at its Norwood, MA site to provide CMC executional support for method-related activities across late-phase development and commercial programs.

The role will contribute to analytical method validation, transfer, and lifecycle management activities in support of product development, regulatory submissions, and commercial readiness.