Sr. Principal Scientist, Analytical Development (Small Molecule San Diego Based)

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 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)

About the Role:

Responsible for leading a sub-team in analytical development and/or serve as an analytical lead for multiple projects to guide the analytical activities for supporting drug substance and drug product development from preclinical through commercial phase. Develops, establishes and validates testing methods used to control raw materials, in process testing, intermediates, API and drug products. Responsible for development and implementation 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.

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Your Contributions (include, but are not limited to):

Your Contributions (include, but are not limited to):

• Leads and manages multiple projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on CMC plans for all development projects

• Manages designs, plans and executes activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities

• Directs 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 Chemical and Product Development

• Develop and support off-site analytical transfers, manufacturing support and interaction with contractors

• Supplies input into CMC regulatory documentation and supporting work

• Facilitates effective supervision of laboratory personnel and guidance for their professional development

• Leverages literature, ICH/ Regulatory guidance, and practical experience to perform their work and influence CMC strategies

• Contributes to development of policies and department strategies

• Builds and enhances internal and external