Stability Manager

Role: Stability Manager within Vaxcyte's Vaccine Product Development organization, focusing on managing cGMP stability programs for preclinical and clinical vaccine candidates. Responsibilities: design, execute, and analyze stability studies in compliance with regulatory standards; develop and maintain stability databases; perform statistical analyses using tools like JMP; prepare reports, SOPs, and regulatory documentation; monitor stability trends; lead continuous improvement initiatives; and manage stability-related GMP documentation, deviations, and investigations. Requirements: MS or BS with at least 8 years of pharma/biotech experience, with strong knowledge of vaccine stability principles, analytical methodologies, regulatory guidelines (FDA, EU, ICH), and statistical tools; extensive technical writing skills; experience in regulated environments (GMP/GLP), and familiarity with IND, NDA, or BLA submissions is highly preferred. High-Value: biologics/vaccines, stability testing, regulatory compliance, GxP environment, technical data analysis, global vendor collaboration, development stage in preclinical/clinical. WorkSetup: based in San Carlos, CA, with competitive salary range $147K–$171K plus benefits and equity.