Analytical Method Transfer & Validation Lead

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

Job summary

Moderna is seeking a technically seasoned leader to direct analytical method lifecycle management across commercial and late-stage programs.

You will drive method transfer, validation, troubleshooting, investigations, and continuous improvement within QC labs, manufacturing, and external testing partners; collaborating across Quality, Regulatory, and CMOs to ensure robust analytical performance and inspection readiness.

Qualifications

• Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 5+ years of relevant industry experience.
• Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline with 3+ years of relevant industry experience.
• 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.

Skills

Analytical method transfer

GMP regulatory knowledge

Data trend analysis

Cross-functional collaboration

Documentation writing

Investigations (OOS/OOT)

Education

Bachelor's degree in Analytical Chemistry or related field

Master's degree in Analytical Chemistry or related field

PhD in Analytical Chemistry or related field

Tools

GMP systems

Job description

Moderna is seeking a technically seasoned leader to direct analytical method lifecycle management across commercial and late-stage programs.

You will drive method transfer, validation, troubleshooting, investigations, and continuous improvement within QC labs, manufacturing, and external testing partners; collaborating across Quality, Regulatory, and CMOs to ensure robust analytical performance and inspection readiness.