Analytical Methods Lead: Chemistry Validation & Transfer

Moderna; Norwood (KY); On-site; USD 109,000 - 175,000; Full time

Job summary

Moderna seeks an experienced analytical chemistry leader to oversee method transfer, validation, troubleshooting, investigations, and continuous improvement for chemistry-based analytical methods. You will partner with QC, QA, Regulatory Affairs, and CMOs to ensure robust, inspection-ready analytical performance across a global network.

The role emphasizes HPLC/UPLC, compendial methods, data analysis, CAPA development, and documentation to support GMP manufacturing and regulatory submissions.

Qualifications

• Bachelor’s degree or higher in Analytical Chemistry or related field with 5+ years of industry experience.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management in GMP environments.
• Experience authoring technical documents (protocols, reports, SOPs) and working knowledge of GMP data integrity.

Responsibilities

• Lead chemistry-focused analytical method transfers, validations, verifications, and comparability assessments across internal/external labs.
• Provide expertise for chromatography-based methods performance monitoring and lifecycle management.
• Collaborate cross-functionally to support investigations, CAPAs, and regulatory readiness.

Skills

Analytical chemistry

HPLC/UPLC

Method transfer

Troubleshooting

Data review

Education

BS in Chemistry

MS in Analytical Chemistry

PhD in Analytical Chemistry

Tools

HPLC systems

Analytical instrumentation

Job description

Moderna seeks an experienced analytical chemistry leader to oversee method transfer, validation, troubleshooting, investigations, and continuous improvement for chemistry-based analytical methods. You will partner with QC, QA, Regulatory Affairs, and CMOs to ensure robust, inspection-ready analytical performance across a global network.

The role emphasizes HPLC/UPLC, compendial methods, data analysis, CAPA development, and documentation to support GMP manufacturing and regulatory submissions.