Senior Analytical Method Lifecycle Lead

Initial Therapeutics, Inc.; Norwood (MA); Hybrid; USD 109,200 - 174,600; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Paid time off

Discretionary bonus potential

Equity options

Job summary

Moderna is seeking a technically driven leader to oversee analytical method lifecycle management across commercial and late-stage programs. The role includes method transfer, validation, troubleshooting, investigations, and CAPA-driven improvements within QC labs, manufacturing, and CMOs.

You will collaborate across QA, Regulatory, Manufacturing Sciences, and CMOs to ensure robust analytical performance and inspection readiness.

Qualifications

• 5+ years of relevant industry experience with degree in analytical sciences.
• Experience supporting analytical method transfer, qualification, validation, verification, or lifecycle management in GMP-regulated settings.
• Experience authoring and reviewing technical documents (protocols, reports, SOPs).
• Working knowledge of GMP data integrity and quality systems.

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.
• Evaluate analytical method suitability and identify opportunities for continuous improvement.

Skills

GMP knowledge

Data integrity

Cross-functional collaboration

Analytical method transfer/validation

Investigations (OOS/OOT)

Education

Bachelor’s degree in Analytical Chemistry

Master’s degree in Analytical Chemistry

PhD in Analytical Chemistry

Job description

Moderna is seeking a technically driven leader to oversee analytical method lifecycle management across commercial and late-stage programs. The role includes method transfer, validation, troubleshooting, investigations, and CAPA-driven improvements within QC labs, manufacturing, and CMOs.

You will collaborate across QA, Regulatory, Manufacturing Sciences, and CMOs to ensure robust analytical performance and inspection readiness.