Scientific Director, Analytical Development

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (*in collaboration with AbbVie)

About the Role:

Recognized as a scientific expert and leader in advanced analytical technologies for Chemistry, Manufacturing and Controls (CMC) development. Serve as an analytical lead leading multiple projects and/or lead a sub-team in analytical development to guide analytical activities. Develops strategy and driving execution for analytical activities internally and externally associated with process and formulation development in support of clinical manufacturing of drug substance and drug product for small molecule and peptides drug candidates to support preclinical studies, clinical development, registration, and commercialization. Provides scientific leadership for junior scientific staff. Serves on cross functional CMC teams responsible for analytical related CMC strategy and deliveries, including regulatory submissions. Responsible for development and implementation of analytical control strategies including specification setting and method development, with special emphasis on 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):

• Leads analytical development activities for small molecules and peptides and serves as the analytical representative for cross-functional technical development teams which will include representatives from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality assurance organizations

• Oversees analytical method development, validation and transfer, specification strategy, GMP testing, and stability studies for drug substance and drug product internally and externally

• Directs the use of established and new techniques including HPLC/UPLC, LC-MS, GC, spectroscopy, NMR, dissolution, wet chemistry, physical characterization techniques (e.g., PXRD) to generate and interpret data

• Solves co