Analytical Methods Lifecycle Lead

Biopharma Careers; Norwood (KY); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Job summary

Moderna is seeking an Analytical Methods Lead to provide technical leadership and execution support for lifecycle management across commercial and late-stage programs. You will guide method transfer, validation, troubleshooting, investigations, and continuous improvement within QC labs, manufacturing, and external testing partners.

This role partners with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and CMOs to ensure robust analytical performance, compliance,

Qualifications

• Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience; OR
• Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience; OR
• PhD in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 0–2 years of relevant industry experience.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management activities in a GMP-regulated pharmaceutical, biotechnology, biologics, or vaccine environment.
• Experience authoring and reviewing technical documents, including protocols, reports, specifications, test methods, investigations, and standard operating procedures (SOPs).
• Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems.
• Experience supporting laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviation, or atypical result assessments.
• Demonstrated ability to analyze scientific data, identify trends, and apply scientific judgment to solve technical problems.
• Experience working effectively in cross-functional teams with Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, and/or external partners.

Responsibilities

• Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external laboratories.
• Provide technical expertise for method performance monitoring and lifecycle management activities.
• Evaluate analytical method suitability and identify opportunities for continuous improvement.
• Serve as a subject matter expert for analytical methods and testing processes.
• Support troubleshooting of analytical issues impacting laboratory operations, manufacturing, and product disposition.
• Collaborate cross-functionally to identify root causes and implement effective corrective actions.
• Support laboratory investigations, out-of-specification (OOS), out-of-trend (OOT), and atypical result assessments.
• Perform scientific data analysis to identify trends, risks, and opportunities for process improvement.
• Contribute to development and implementation of CAPAs to address analytical and operational issues.
• Author, review, and approve technical documents including protocols, reports, methods, specifications, and standard operating procedures (SOPs).
• Ensure documentation is accurate, compliant, and inspection-ready.
• Support regulatory submissions, health authority inspections, and internal audits as required.
• Collaborate with QC laboratories and external testing partners to ensure successful method implementation and execution.
• Provide technical oversight and support for analytical activities conducted at CMOs and contract testing laboratories.
• Support network harmonization efforts and best-practice sharing across sites.
• Analyze analytical performance metrics and trending data to drive informed decision-making.
• Support development and implementation of process improvements that enhance efficiency, compliance, and robustness.
• Contribute to digital and data-driven initiatives supporting analytical operations.

Skills

Analytical leadership

Technical leadership

Data analysis

Cross-functional collaboration

Problem solving

Education

Bachelor's in Analytical Chemistry or related

Master's in Analytical Chemistry or related

PhD in Analytical Chemistry or related

Tools

SOPs

GMP knowledge

Job description

Moderna is seeking an Analytical Methods Lead to provide technical leadership and execution support for lifecycle management across commercial and late-stage programs. You will guide method transfer, validation, troubleshooting, investigations, and continuous improvement within QC labs, manufacturing, and external testing partners.

This role partners with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and CMOs to ensure robust analytical performance, compliance,