Senior Analytical Chemistry Lead: Method Transfer & QC

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Moderna is seeking an analytical leader to drive method lifecycle management across development programs. You will lead method transfers, validations, troubleshooting, investigations, and CAPA-driven improvements in QC labs, manufacturing operations, and with CMOs.

You’ll collaborate across Quality Control, Quality Assurance, Regulatory Affairs, and CMOs to ensure robust analytical performance and inspection readiness.

Qualifications

• Bachelor's degree with 5+ years in industry; or Master’s with 3+ years; or PhD with 0–2 years.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management in GMP environments.
• Experience authoring technical documents: protocols, reports, SOPs.

Responsibilities

• Lead and support chemistry-focused analytical method transfers, validations, verifications, and comparability assessments.
• Provide technical expertise for method performance monitoring, troubleshooting, and lifecycle management.
• Collaborate across QC, QA, Regulatory, and CMOs to ensure robust analytical performance.

Skills

HPLC/UPLC

Chromatographic methods

Data analysis

Troubleshooting

Cross-functional collaboration

Education

Bachelors in Analytical Chemistry or related

Master’s in Analytical Chemistry or related

PhD in Analytical Chemistry or related

Tools

USP methods

GMP regulatory knowledge

Job description

Moderna is seeking an analytical leader to drive method lifecycle management across development programs. You will lead method transfers, validations, troubleshooting, investigations, and CAPA-driven improvements in QC labs, manufacturing operations, and with CMOs.

You’ll collaborate across Quality Control, Quality Assurance, Regulatory Affairs, and CMOs to ensure robust analytical performance and inspection readiness.