Analytical Method Lifecycle Lead

RXinsider LTD.; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Professional development opportunities

Job summary

Moderna is seeking an experienced analytical chemistry leader to drive method transfer, validation, troubleshooting, and lifecycle management across internal and external labs. You will collaborate with QC, QA, regulatory, and CMOs to ensure compliant, robust analytical performance.

The role emphasizes data-driven decision making, investigations of OOS/OOT results, and development of CAPAs to improve processes and product quality across commercial and late-stage programs.

Qualifications

• Bachelor's degree with 5+ years in GMP regulated environments or higher degrees with corresponding experience.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management.
• Experience authoring and reviewing technical documents and SOPs.

Responsibilities

• Lead method transfers, validations, verifications, and comparability assessments across labs.
• Provide technical expertise for method performance monitoring and lifecycle management.
• Collaborate cross-functionally to ensure robust analytical performance and compliance.
• Support investigations, OOS/OOT assessments, and CAPA development.
• Author, review, and approve protocols, reports, specifications, and SOPs.
• Provide technical oversight for external partners and CMOs.

Skills

Analytical method transfer

GMP compliance

Data analysis

Cross-functional collaboration

Technical leadership

Education

Master's degree in Analytical Chemistry / related field

PhD in Analytical Chemistry / related field

Tools

HPLC/GC instrumentation

LC-MS techniques

Job description

Moderna is seeking an experienced analytical chemistry leader to drive method transfer, validation, troubleshooting, and lifecycle management across internal and external labs. You will collaborate with QC, QA, regulatory, and CMOs to ensure compliant, robust analytical performance.

The role emphasizes data-driven decision making, investigations of OOS/OOT results, and development of CAPAs to improve processes and product quality across commercial and late-stage programs.