Analytical Method Lifecycle Lead

BioSpace; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning support

Generous PTO

Job summary

Moderna is seeking a technical leader to oversee analytical method lifecycle management across commercial and late-stage programs. You will lead method transfers, validations, troubleshooting, investigations, and CAPA-driven improvements in collaboration with QC, regulatory, and CMOs.

The role requires strong GMP knowledge, data analysis, and cross-functional leadership to ensure robust analytical performance and inspection readiness across sites.

Qualifications

• Bachelor's degree in Analytical Chemistry or related with 5+ years of industry experience.
• Master's degree in Analytical Chemistry or related with 3+ years of industry experience.
• PhD in Analytical Chemistry or related with 0–2 years of industry experience.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management in GMP-regulated environments.
• Experience authoring and reviewing technical documents (protocols, reports, specifications, SOPs).
• Working knowledge of GMP regulations, data integrity principles, and pharmaceutical quality systems.
• Experience supporting laboratory investigations (OOS/OOT/deviation) and data interpretation.

Responsibilities

• Lead and support analytical method transfers, validations, verifications, and comparability assessments across internal and external labs.
• Provide technical expertise for method performance monitoring and lifecycle management activities.
• Evaluate analytical method suitability and identify opportunities for continuous improvement.
• Serve as subject matter expert for analytical methods and testing processes.
• Support troubleshooting of analytical issues impacting laboratory operations and manufacturing.
• Collaborate cross-functionally to identify root causes and implement corrective actions.
• Support laboratory investigations and data analysis to identify trends and risks.
• Author, review, and approve technical documents; ensure inspection readiness.
• Collaborate with QC laboratories and CMOs to ensure method implementation and execution.
• Analyze performance metrics and contribute to process improvements.

Skills

GMP knowledge

Data analysis

Technical leadership

Cross-functional collaboration

Documentation writing

Education

Bachelor's degree in Analytical Chemistry or related

Master's degree in Analytical Chemistry or related

PhD in Analytical Chemistry or related

Job description

Moderna is seeking a technical leader to oversee analytical method lifecycle management across commercial and late-stage programs. You will lead method transfers, validations, troubleshooting, investigations, and CAPA-driven improvements in collaboration with QC, regulatory, and CMOs.

The role requires strong GMP knowledge, data analysis, and cross-functional leadership to ensure robust analytical performance and inspection readiness across sites.