Senior Analytical Development Scientist – Method Validation

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

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna Therapeutics in Norwood, MA is seeking an analytical development scientist to advance method development and validation for clinical-stage qualification and commercial readiness.

The role emphasizes cross-functional collaboration with Quality, QC and manufacturing, troubleshooting complex assay issues, and driving continuous improvement in lifecycle management of analytical methods. Strong GMP experience and data interpretation are essential.

Qualifications

• This role requires MS with 5 years or BS with 8 years in biotech/pharma analytical development.
• Strong hands-on experience with analytical methods (HPLC, absorption, molecular biology assays).
• Experience with method transfer to QC or external labs and GMP environmental context.

Responsibilities

• Mitigate risks in method development and validation per ICH Q2/Q14.
• Troubleshoot complex assay results and issues.
• Drive continuous improvement for method transfer and routine operations.
• Ensure robust method development for clinical-stage qualification and commercial validation-readiness.
• Collaborate across Method Development, AST, ATO, QC to align analytical expectations.
• Represent Analytical Development in cross-functional forums with AS&T and QC.
• Ensure methods meet technical, operational, and regulatory requirements.
• Lead investigations and root-cause analyses for performance issues.
• Influence method development and lifecycle improvements based on data.
• Collaborate with Quality and AST on deviations, CAPAs, and change controls.
• Analyze complex datasets to inform performance and variability.
• Author and review protocols, reports, and method lifecycle documents.

Skills

Analytical methods

HPLC

Absorption assays

Molecular biology assays

Method transfer

GMP experience

Cross-functional collaboration

Data interpretation

Communication

Ownership

Education

MS with 5 years' biotech/pharma analytical development experience

Job description

Moderna Therapeutics in Norwood, MA is seeking an analytical development scientist to advance method development and validation for clinical-stage qualification and commercial readiness.

The role emphasizes cross-functional collaboration with Quality, QC and manufacturing, troubleshooting complex assay issues, and driving continuous improvement in lifecycle management of analytical methods. Strong GMP experience and data interpretation are essential.