Senior Director, Analytical Development, Testing and Lab Automation

Role: Senior Director of Analytical Development overseeing strategy and execution for cell, gene, and biologic therapies. Responsibilities include leading manual and automated testing strategies, managing analytical operations, and advancing automation and digitization efforts such as AI and machine learning integration. The role involves close collaboration with Manufacturing, Process Development, Regulatory, and Quality teams to generate high-quality data supporting process characterization and control strategies. Core duties include establishing testing frameworks, leading automation platform development, managing laboratory informatics, and building organizational capability through scientific and leadership excellence. Qualifications: Master’s or PhD in analytical chemistry, biochemistry, immunology, or related fields, with 11+ years (PhD) or 15+ years (Master’s) of relevant industry experience—preferably with cell therapy, biologics, or genetic therapies. Expertise in analytical method development, automation, digitization, and regulatory standards (ICH, FDA, USP) are essential. High-value specifics: focus on cell and gene therapy modalities, process development, process characterization, stability studies, and analytical automation. The position is based on-site with a flexible work schedule and requires extensive leadership, stakeholder engagement, and innovation in analytical sciences.