Principal Research Associate, Analytical Science & Technology

Role: Analytical CMC Specialist supporting late-phase development and commercial programs at Moderna's Norwood, MA site. Responsibilities: manage analytical method validation, transfer, verification, lifecycle management, and documentation to ensure regulatory compliance and timely project delivery; coordinate with internal labs, external partners, QA, and regulatory teams; author, revise, and organize analytical documentation for regulatory submissions and inspections; support lifecycle updates, change controls, and post-approval activities; assist in regulatory responses and gap assessments; maintain organized records and support meeting preparations. Requirements: Bachelor's in Chemistry, Biochemistry, or related field; 3+ years in Analytical Development, Quality Control, or Analytical Sciences within GMP-regulated biopharma; experience with method qualification, validation, transfer, and lifecycle management; knowledge of ICH, GMP, and regulatory documentation standards; strong technical writing, organization, and cross-functional collaboration skills. Preferred: experience with biologics, vaccines, or complex modalities; supporting validation and regulatory submissions; working with external labs or manufacturing networks; ability to manage multiple priorities. HighValue: support for late-phase clinical or commercial biologics/vaccine programs, analytical lifecycle management, documentation for regulatory filings, cross-functional coordination, GMP compliance. WorkSetup: On-site in Norwood, MA, with a collaborative environment.