Principal Scientist, Analytical Development
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About the role
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 patients with 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 ) Responsible for leading analytical development activities for multiple projects to support drug substance development from preclinical through commercial phase, with a focus on small molecules. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API. Responsible for development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects. _ Your Contributions (include, but are not limited to): Plans and manages projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects Independently designs, plans and executes activities towards the goals of one or more analytical chemistry projects to support pre-clinical through commercial activities, as well as contributing to overall control strategy Supervises laboratory work and/or lab personnel and ensures safe laboratory practices Performs analytical development and optimizes methods in support of preclinical through commercialization Creates and implements novel ideas and techniques to support analytical activities with API Development Provides support for off-site analytical transfers, manufacturing support and interaction with contractors Provides input into CMC regulatory documentation and supporting work Provides effective supervision of laboratory personnel and guidance for their professional development Contributes to development of policies and department strategies Builds and enhances internal and external professional relationships Presents finding at varying levels across the company Supports career development and technical growth of direct reports Other duties as assigned