Associate Scientific Director API Development, MSAT

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 ) About the Role: The Associate Scientific Director, Manufacturing Science & Technology (MSAT) provides technical leadership across the product lifecycle of API synthetics to ensure robust, scalable, and compliant manufacturing of commercial and late-stage clinical API. This role leads technology transfer, process validation, lifecycle management, continuous improvement, and manufacturing support across global external manufacturing networks. This leader partners across Technical Development, External Operations, Quality, Regulatory Affairs, and Supply Chain to enable successful commercialization, reliable product supply, and continuous process excellence. The position combines scientific and engineering expertise with strategic leadership to develop organizational capabilities, drive innovation, and support corporate objectives. _ Your Contributions (include, but are not limited to): Technical Leadership Lead the development and execution of manufacturing science and technology strategies supporting commercial manufacturing and lifecycle management Serve as the technical authority for late-stage clinical and commercial manufacturing processes across API synthetics Translate laboratory and pilot-scale processes into robust, scalable, validated, and commercially sustainable manufacturing operations Lead technical assessments, root cause investigations, complex troubleshooting, and implementation of innovative engineering and process solutions Develop manufacturing control strategies that ensure product quality, process robustness, and regulatory compliance Technology Transfer & Commercialization Lead end-to-end technology transfer activities from Technical Development through commercial manufacturing Establish commercial manufacturing readiness by coordinating process validation, engineering studies, comparability assessments, and manufacturing campaigns Partner with Contract Development and Manufacturing Organizations (CDMOs) to ensure successful process implementation Provide technical oversight during product launches, capacity expansions, and manufacturing network transfers Process Optimization & Continuous Improvement Drive process optimization initiatives that improve manufacturing robustness, product quality, yield, reliability, and cost of goods Lead cross-functional continuous improvement programs utilizing science- and risk-based methodologies Identify process vulnerabilities and implement corrective and preventive actions that improve operational performance Champion Lifecycle Management (LCM) strategies supporting product enhancements, post-approval changes, and manufacturing sustainability Regulatory & Quality Support Provide technical leadership supporting global regulatory submissions, inspections, and responses Author and review technical reports, validation