Director - GQ-LMAS - Vaccine Methods Team Lead

Role: Lead a team of SMEs supporting vaccine analytical methods within the Global Quality Large Molecule Analytical Sciences – Central Vaccine Labs, focusing on methods for HPV, PCV, and other vaccines. Objectives include providing technical oversight, lifecycle management, and strategic direction for analytical testing to ensure product quality, potency, and safety. Responsibilities encompass managing cross-functional collaborations with quality, R&D, regulatory, and external labs; overseeing method validation, transfer, troubleshooting, and modernization; and supporting regulatory submissions. Qualifications: 15+ years (Master's/Bachelor's) or 10+ years (PhD) in analytical testing, development, or validation, with extensive GMP experience, especially supporting biologics or vaccines. Required skills include strong leadership, expertise in bioassays, immunoassays, chromatography, biophysical and characterization techniques, and knowledge of regulatory guidelines (e.g., ICH Q2/Q14). Experience with recombinant/conjugate vaccines, analytical lifecycle management, and cross-functional team leadership is preferred. High-value specifics: vaccine franchise, GMP environments, analytical lifecycle activities, reference standard strategy, method validation, and troubleshooting at global testing sites. The role involves 10% travel, is based in a hybrid work setup, and reports to senior management within the QA Analytical Sciences team.