Analytical Method Lead - Validation, Transfer & Lifecycle

Moderna Therapeutics; Norwood (MA); On-site; USD 95,000 - 140,000; Full time

Job summary

Moderna Therapeutics in the United States seeks a project management and coordination specialist to support analytical method activities across late-stage development and commercial programs. You will help maintain timelines, trackers, action logs, deliverable lists, and status updates, ensuring alignment with internal expectations and milestones.

You will collaborate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to drive timely execution,

Qualifications

Responsibilities

• Provide project management and coordination support for analytical method activities across late-phase development and commercial programs.
• Maintain timelines, trackers, action logs, deliverable lists, and status updates.
• Support validation, transfer, verification, and lifecycle management activities to meet regulatory requirements and milestones.
• Coordinate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams.
• Assist with compiling, organizing, and reviewing analytical documentation and data packages for regulatory submissions.
• Support regulatory query responses by gathering technical inputs and tracking deliverables.

Job description

Moderna Therapeutics in the United States seeks a project management and coordination specialist to support analytical method activities across late-stage development and commercial programs. You will help maintain timelines, trackers, action logs, deliverable lists, and status updates, ensuring alignment with internal expectations and milestones.

You will collaborate with internal laboratories, external testing partners, Quality, Regulatory CMC, and program teams to drive timely execution,