Associate Scientific Director API Development, MSAT

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)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 managementServe as the technical authority for late-stage clinical and commercial manufacturing processes across API syntheticsTranslate laboratory and pilot-scale processes into robust, scalable, validated, and commercially sustainable manufacturing operationsLead technical assessments, root cause investigations, complex troubleshooting, and implementation of innovative engineering and process solutionsDevelop manufacturing control strategies that ensure product quality, process robustness, and regulatory complianceTechnology Transfer & Commercialization Lead end-to-end technology transfer activities from Technical Development through commercial manufacturingEstablish commercial manufacturing readiness by coordinating process validation, engineering studies, comparability assessments, and manufacturing campaignsPartner with Contract Development and Manufacturing Organizations (CDMOs) to ensure successful process implementationProvide technical oversight during product launches, capacity expansions, and manufacturing network transfersProcess Optimization & Continuous Improvement Drive process optimization initiatives that improve manufacturing robustness, product quality, yield, reliability, and cost of goodsLead cross-functional continuous improvement programs utilizing science- & risk-based methodologiesIdentify process vulnerabilities and implement corrective and preventive actions that improve operational performanceChampion Lifecycle Management (LCM) strategies supporting product enhancements, post-approval changes, and manufacturing sustainabilityRegulatory & Quality Support Provide technical leadership supporting global regulatory submissions, inspections, and responsesAuthor and review technical reports, validation documentation, regulatory filings, comparability protocols, and change control documentationEnsure manufacturing processes remain compliant with global cGMP regulations and evolving regulatory expectationsPartner with Quality to investigate deviations, implement CAPAs, and maintain inspection readinessTechnical Leadership Develop and execute departmental strategies aligned with Technical Operations and corporate objectivesLead complex cross-functional initiatives supporting commercialization, supply reliability, and portfolio growthInfluence organizational strategy through scientific leadership, technical governance, and data-driven decision makingBuild strong partnerships across Technical Operations, Regulatory Affairs, Quality, and Commercial organizationsOrganizational Leadership Build, develop, and mentor high-performing engineering and scientific partnershipsFoster a culture of technical excellence, innovation, collaboration, and continuous learningDevelop organizational capabilities that support emerging technologies, new modalities, and future portfolio needsSuccess MeasuresSuccess in this role will be demonstrated through:Successful commercialization and technology transfer of new productsReliable commercial manufacturing performanceImproved process capability, yield, and operational efficiencySuccessful regulatory inspections and submissionsEffective lifecycle management and continuous improvement initiativesDevelopment of high-performing technical teamsStrong cross-functional partnerships that accelerate delivery of medicines to patientsRequirements:BS/BA in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 14+ years of similar experience noted above OR MS/MA in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 8+ years of relevant experience OR PhD in chemistry, biochemistry, biology, chemical engineering, or similar discipline and 6+ years of relevant experienceRelevant experience includes:Manufacturing Science & Technology (MSAT)Commercial pharmaceutical manufacturingTechnology TransferProcess ValidationProcess EngineeringLifecycle ManagementExternal Manufacturing / CDMO oversightRegulatory submissions and inspectionsContinuous Improvement / Operational ExcellenceTechnical ExpertiseAdvanced knowledge of pharmaceutical process development, scale-up, validation, and commercial manufacturingExpertise in Manufacturing Science & Technology (MSAT), process engineering, technology transfer, and lifecycle managementStrong understanding of cGMP regulations, Quality Systems, Process Validation, Continued Process Verification, and regulatory requirementsDemonstrated experience supporting clinicalcommercial manufacturing operations and post-commercialization process improvementsExpertise in risk management, statistical analysis, root cause investigations, and data-driven decision makingLeadership CompetenciesProven ability to lead complex technical organizations and cross-functional programsStrategic thinker capable of balancing technical excellence with business prioritiesExceptional communication and executive presentation skillsStrong collaboration, negotiation, and stakeholder management capabilitiesDemonstrated success influencing senior leadership and external partners #LI-OS1Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license.OUR VALUES:PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent.INNOVATION: We seek and create optimal solutions.TENACITY: We do not quit. We adapt. We accomplish what others cannot.Come join our team during this exciting time of growth and opportunities! #J-18808-Ljbffr