Senior Analytical Method Transfer Lead

Pharmadog; Norwood, Northern (MA, KY); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Paid time off

Location-specific perks

Job summary

Moderna is seeking a scientifically rigorous analyst to lead transfers of analytical methods from development into routine testing labs. The role emphasizes robust transfer packages, risk-based readiness assessments, and cross-functional collaboration to maintain method integrity and regulatory alignment.

You will collaborate with AST, QC, ATO, and Regulatory to ensure transfer success across clinical and commercial testing environments, with strong emphasis on ICH/Q2(Q2R2), Q14, and GMP

Qualifications

• PhD in analytical chemistry or related field with industry experience, or MS with extensive experience, or BS/BA with long tenure in analytical development.
• Experience leading analytical method transfers into GMP environments.
• Strong writing and collaboration across multiple functions.

Responsibilities

• Lead analytical sciences transfer for methods into ATO and QC laboratories.
• Design transfer strategies, acceptance criteria and study designs.
• Perform readiness assessments using development data and risk analysis.
• Troubleshoot method transfer issues and drive corrective actions.
• Develop complete transfer packages with scientific rationale and parameters.

Skills

Analytical method development

Method transfer

GMP knowledge

Regulatory knowledge

Root-cause analysis

Education

PhD in Analytical Chemistry

MS in a related field

BS/BA with 12+ years in related functions

Job description

Moderna is seeking a scientifically rigorous analyst to lead transfers of analytical methods from development into routine testing labs. The role emphasizes robust transfer packages, risk-based readiness assessments, and cross-functional collaboration to maintain method integrity and regulatory alignment.

You will collaborate with AST, QC, ATO, and Regulatory to ensure transfer success across clinical and commercial testing environments, with strong emphasis on ICH/Q2(Q2R2), Q14, and GMP