Senior Stability Specialist, Quality Control

Role: Senior GMP Stability Specialist serving as a technical expert in stability programs within biopharmaceutical manufacturing. Responsibilities: lead design and lifecycle management of stability studies for clinical and commercial products; act as SME during audits; assess stability data to inform product shelf life, storage, and regulatory commitments; perform statistical trend analysis and lead investigations of stability deviations; author stability documentation; support regulatory submissions and change assessments; drive continuous improvement and system validation; mentor junior staff and collaborate cross-functionally with Quality Control, QA, Manufacturing, and Regulatory teams. Requirements: Bachelor's in Chemistry, Pharmaceutical Sciences, or related field; 5-8+ years in GMP pharmaceutical/biotech environment; experience with stability programs, QC operations, or analytical testing preferred. HighValue: expertise in stability management, GMP compliance, regulatory support, and cross-functional collaboration in biopharma manufacturing. WorkSetup: on-site in Massachusetts, full-time.