Associate Principal Scientist, Analytical R&D

Role: Lead global analytical transfer activities for large molecules including vaccines, mAbs, and biologics within the GQ-LMAS team, focusing on late-stage method transfer, validation, and lifecycle management to support commercialization. Responsibilities: oversee complex analytical transfers, develop and troubleshoot assays, conduct risk assessments, manage international registration and import activities, and collaborate with manufacturing and testing sites, including CMOs. Requirements: Bachelor’s degree in science with 6+ years (or Master’s with 4+ years, PhD with 1+ year) in biologics/large molecule development, validation, or QC; strong knowledge of ICH, USP, and GxP practices; experience in late-stage method transfer, validation, and cGMP labs; project management skills; effective communication and stakeholder management. Preferred: experience with regulatory filings (IND, BLA, MAA), global launch support, lean six sigma, deviation/change control processes. HighValue: biologics, vaccines, mAbs, ADCs; late-stage development; regulatory submissions; international manufacturing support; cGMP environment; 10% travel; hybrid work setup.