Sr. Manager, Analytical Development GMP Lab

Role: Lead analytical development and GMP laboratory operations supporting Neurocrine's programs from preclinical to commercialization, ensuring high-quality and compliant analytical execution. Responsibilities: oversee laboratory staffing, budgeting, and resource allocation; develop and maintain GMP-compliant SOPs and systems; manage stability testing, method validation, qualification, transfer, and characterization of GLP/GMP samples; supervise internal staff and review data for accuracy and compliance; support external analytical collaborations; contribute to CMC regulatory documentation; and lead operational improvements. Requirements: Bachelor's in Chemistry or life sciences with 8+ years, Master's with 6+ years, or PhD with 4+ years of relevant analytical experience in pharma; expertise in analytical method validation, transfer, and adherence to cGMP, GLP, ICH, and FDA guidelines; strong leadership and project management skills; excellent communication and problem-solving abilities. HighValue: GMP/GLP analytical operations, method validation, stability testing, CMC regulatory input, cross-functional collaboration, support from preclinical through commercial stages, leadership in analytical sciences. WorkSetup: Not specified.