Analytical Method Scientist - Validation, Transfer, Lifecycle

Moderna Therapeutics; Norwood, Northern (MA, KY); Hybrid; USD 95,000 - 145,000; Full time

Job summary

Moderna Therapeutics in Norwood, MA is seeking a project management and coordination professional to support analytical method activities across late-phase development and commercial programs. You will maintain timelines, trackers, and logs, and help with validation, transfer, and lifecycle management to align with regulatory requirements and program milestones.

The role involves coordinating with internal labs, external partners, and cross-functional teams, authoring analytical documentation,

Qualifications

• Experience coordinating analytical method development or validation activities.
• Strong documentation and regulatory submission support skills.

Responsibilities

• Maintain project timelines, trackers, action logs, and status updates across analytical method activities.
• Support planning, execution tracking, and follow-up for method validation, transfer, verification, and lifecycle management.
• Coordinate with internal labs, external testing partners, and program teams to address documentation gaps.
• Author and revise validation plans, transfer documents, method summaries, and technical memos.
• Assist with compiling regulatory submissions and responses, ensuring traceability and inspection readiness.

Skills

Project management

Analytical method development

Regulatory CMC familiarity

Cross-functional coordination

Job description

Moderna Therapeutics in Norwood, MA is seeking a project management and coordination professional to support analytical method activities across late-phase development and commercial programs. You will maintain timelines, trackers, and logs, and help with validation, transfer, and lifecycle management to align with regulatory requirements and program milestones.

The role involves coordinating with internal labs, external partners, and cross-functional teams, authoring analytical documentation,