Senior Analytical Development Lead: Method Transfer

Moderna; Norwood (MA); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Healthcare benefits

Discretionary bonus

Equity opportunities

Paid time off

Job summary

Moderna is seeking a Principal Research Associate to bridge Analytical Development with AST, QC, ATO, and QA, ensuring robust method development for clinical-stage qualification and commercial validation-readiness. The role emphasizes HPLC and molecular biology assay expertise, method transfer, and risk mitigation per ICH Q2/Q14.

The ideal candidate will troubleshoot complex assay results, own investigations, and drive continuous improvement across method transfer and routine operations in a

Qualifications

• MS or BS with relevant biotech/pharma analytical development experience.
• Deep technical expertise in analytical methods including HPLC and molecular biology assays.
• Experience with method transfer to QC or external labs.
• Proven ability to troubleshoot complex assay issues and lead investigations in GMP or late-stage development.
• Knowledge of CQA frameworks, assay lifecycle management, and regulatory expectations.
• Experience collaborating with Quality, QC, and manufacturing organizations.

Responsibilities

• Serve as liaison between Method Development, AST, ATO, and QC to align analytical method expectations and readiness.
• Represent Analytical Development in cross-functional forums with AS&T and QC.
• Ensure methods meet technical, operational, and regulatory requirements prior to qualification or validation.
• Lead investigations for root causes, support hypothesis testing, implement solutions.
• Influence method development, assay optimization, and continuous improvement based on feedback and lifecycle needs.
• Collaborate with Quality and AST for deviation investigations, CAPAs, and change controls related to analytical methods.
• Analyze and interpret complex datasets to inform performance and comparability.
• Author and review protocols, reports, and lifecycle documents.

Skills

HPLC

Molecular biology assays

Analytical method transfer

GMP

Cross-functional collaboration

Data analysis

Troubleshooting

Method validation

Education

MS in biotech/pharma

BS in biotech/pharma with 8 years experience

Tools

LIMS

Job description

Moderna is seeking a Principal Research Associate to bridge Analytical Development with AST, QC, ATO, and QA, ensuring robust method development for clinical-stage qualification and commercial validation-readiness. The role emphasizes HPLC and molecular biology assay expertise, method transfer, and risk mitigation per ICH Q2/Q14.

The ideal candidate will troubleshoot complex assay results, own investigations, and drive continuous improvement across method transfer and routine operations in a