Senior Analytical Methods Lifecycle Lead

RXinsider LTD.; Norwood, Northern (MA, KY); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Moderna is seeking a technical leader to deliver analytical method lifecycle management across development programs. This role covers method transfer, validation, troubleshooting, investigations, and continuous improvement within Quality Control labs, manufacturing, and external testing partners.

You will collaborate with QC, QA, Regulatory Affairs, Manufacturing Sciences, and CMOs to ensure analytical performance, compliance, and inspection readiness, driving robust solutions and reliable

Responsibilities

• Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
• Provide technical expertise for method performance monitoring and lifecycle management activities.
• Evaluate analytical method suitability and identify opportunities for continuous improvement.
• Serve as a subject matter expert for analytical methods and testing processes.
• Support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition.
• Collaborate cross-functionally to identify root causes and implement effective corrective actions.

Job description

Moderna is seeking a technical leader to deliver analytical method lifecycle management across development programs. This role covers method transfer, validation, troubleshooting, investigations, and continuous improvement within Quality Control labs, manufacturing, and external testing partners.

You will collaborate with QC, QA, Regulatory Affairs, Manufacturing Sciences, and CMOs to ensure analytical performance, compliance, and inspection readiness, driving robust solutions and reliable