Sr. Manager, Analytical Development GMP Lab

Who We Are: Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie ) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role: Leads analytical development and GMP laboratory operations supporting programs from preclinical development through commercialization, ensuring high-quality, compliant analytical execution and delivery. Provides strategic, technical, and people leadership while collaborating across functions and with external partners to advance CMC objectives. _ Your Contributions (include, but are not limited to): Oversee internal laboratory operations, including staffing, scheduling, budgeting, and resource allocation to meet team objectives and goals Implements strategic plans and translates into team's objectives for evaluation criteria for obtaining results; contributes to department strategy determination Develop, implement, and maintain SOPs, systems, and daily practices to uphold GMP compliance within the internal laboratory Manage internal stability testing programs, validation, qualification, and transfer of analytical test methods, instrument qualification, and characterization of GLP/GMP samples Lead the qualification, calibration, and maintenance programs for laboratory instruments to ensure compliance and data integrity Supervise and review the work and data generated by in-sourced personnel, ensuring accuracy, completeness, and adherence to quality standards Manages in-source personnel work and review of the data as needed Maintain complete and accurate documentation of all laboratory activities, including test results, equipment qualification records, SOPs, and training records Hire, train, and develop laboratory personnel to support efficient, compliant, and high-quality operations Prepare for and participate in internal and external audits and regulatory inspections, ensuring continuous readiness and compliance Identify and resolve laboratory operational issues and implement process improvements to enhance efficiency and quality Develops and evaluates personnel to ensure the efficient operation of the functionLeads and manages analytical development and GMP laboratory activities supporting programs from preclinical development through commercialization Represents Analytical Development on cross-functional teams and maintains accountability for analytical deliverables, timelines, and CMC plans Develops and implements analytical strategies, methods, and novel approaches to support Chemical and Product Development activities Oversees analytical method development, validation, qualification, transfer, stability testing, and characterization of GLP/GMP samples Directs internal laboratory operations, including staffing, scheduling, budgeting, resource allocation, and safe laboratory practices Establishes and maintains SOPs, systems, documentation, and laboratory practices to ensure GMP compliance, data integrity, and inspection readiness Oversees laboratory instrument qualification, calibration, maintenance, and associated compliance programs Provides technical oversight and reviews laboratory work and data to ensure accuracy, completeness, quality, and regulatory compliance Supports external analytical activities, including method transfers, manufacturing support, and oversight and collaboration with contractors and external partners Provides analytical input into CMC regulatory documentation and applies scientific literature, ICH/regulatory guidance, and technical expertise to influence CMC strategies Develops and implements department strategies, policies, operational improvements, and team objectives to enhance quality and efficiency Hires, leads, coaches, and develops laboratory personnel, supporting performance, technical growth, career development, and effective team operations Requirements: Bachelor's degree in Chemistry or other life science and 8+ years of analytical experience in the pharmaceutical industry or relevant industry experience OR Master's degree in Chemistry or other life science and 6+ years of applicable experience OR PhD in Chemistry or other life science and 4+ years of applicable experience Working knowledge of cGMP, GLP and GDP Expert in at least one analytical scientific discipline Strong knowledge of analytical method validation and transfer Working knowledge of