Analytical Method Transfer Lead — GMP & Lab Ops

Moderna; Norwood (MA); Presencial; USD 109.000 - 175.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Descripción de la vacante

Moderna is seeking a scientific lead in Analytical Development to transfer and implement analytical methods into Analytical Testing Operations and QC laboratories. You will assess readiness, design transfer strategies, and work with sending and receiving labs to ensure methods are reproducible and compliant with GMP and regulatory expectations.

This role requires substantial hands-on method development experience, proficiency in method performance and troubleshooting, and collaboration across

Formación

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering or related field with 2+ years of industry experience, or MS with 8+ years, or BS/BA with 12+ years in analytical development functions.

Responsabilidades

• Lead transfer of analytical methods from development into testing operations and QC.
• Assess method readiness and design phase-appropriate transfer strategies.
• Collaborate with AD, ATO, QC, AST, Regulatory to ensure robust method transfer.
• Develop and improve transfer protocols, SOPs, and risk assessments.
• Provide scientific support for deviations, OOS/OOT investigations, CAPAs, and post-transfer stabilization.
• Authors transfer protocols, reports, and regulatory documentation.
• Train receiving-laboratory analysts and evaluate analyst/instrument/site effects.
• Monitor transfer outcomes and drive continual method improvements.

Conocimientos

Analytical method transfer

GMP knowledge

Troubleshooting complex methods

Cross-functional collaboration

Scientific writing

Educación

PhD in Analytical Chemistry or related

Descripción del empleo

Moderna is seeking a scientific lead in Analytical Development to transfer and implement analytical methods into Analytical Testing Operations and QC laboratories. You will assess readiness, design transfer strategies, and work with sending and receiving labs to ensure methods are reproducible and compliant with GMP and regulatory expectations.

This role requires substantial hands-on method development experience, proficiency in method performance and troubleshooting, and collaboration across