Principal Scientist, Clinical Process Development

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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 , and follow the company on ,  and . (
* in collaboration with Abb Vie*)##

About the Role:

Responsible for leading the advancement of assigned assets from pre-clinical through commercial phases, including internal process or product development experimentation and collaboration with external partners for development and manufacturing. Good working understanding of investigational product handling in a clinical setting is required. Advanced scientific contributions are required to enable process establishment, optimization, and characterization to ensure robust delivery of the pipeline.

The position also entails contribution to regulatory documentation, quality and cGMP knowledge, and an ability to build strong relationships with cross-functional and external partners. May train and mentor other scientists and/or team members. ## Your Contributions (include, but are not limited to):
* Strategizes and oversees clinical in-use studies to assess material compatibility, in-use shelf life, and define the appropriate clinical handling procedures for investigational products
* Design, author, and oversee the execution of Pharmacy Manuals supporting early-phase clinical trials
* Contributes to clinical protocol design, amendments, and execution of studies assessing dosing, administration, and product handling
* Apply advanced scientific principles to complex challenges in product development lifecycle encompassing definition, optimization, characterization, and validation
* Plans and manage projects. Represents development in cross-functional teams
* Maintains accountability for deliverables including production plans for development projects
* Independently designs, plans and executes advanced activities towards the goals of one or more development projects to support preclinical through commercial activities
* Supervises laboratory work and/or lab personnel and ensures safe laboratory practices
* Proactively identifies process or product challenges and drives necessary optimization activities including trouble-shooting experimentation
* Identifies and recommends novel approaches to improve product quality, product stability, or to achieve cost effectiveness
* Manages contract manufacturing activities and directly interacts with contractors
* Author or contribute to clinical protocols, study reports, regulatory briefing documents, and responses to health authority questions
* May provide supervision of laboratory personnel and guidance for their professional development
* Build and enhance internal and external professional relationships
* Other duties as assigned## Requirements:
* BS/BA in pharmacy, pharmaceutical sciences, chemistry, biochemistry, biology, or similar scientific discipline and 8+ years of experience in formulation research, clinical research, experience managing laboratory, maximizing productivity is desirable OR
* MS/MA…