Sr. Scientist, Product Dev - Late Stage

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:

Participate in developing and executing formulation and process design & engineering to support development projects from Phase I through commercial. Partner, with a Quality by Design (QbD) mindset in full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, process development, scale-up engineering and optimization, packaging and stability testing of oral solid drug products. Ensure product quality, scalability and regulatory compliance. Develop CDMO relationships to support clinical programs. Assist with successful technical transfer for Neurocrine drug products to CDMOs. Participate within project teams to deliver high-quality, phase-appropriate drug products that address molecule- and therapeutic indication-specific challenges of solubility, permeability, and target product profile.

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

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

• Formulation Design and Optimization: Partner in designing and developing robust formulations for solid oral dosage forms (e.g., tablets, capsules), focusing on optimizing for stability, bioavailability, and manufacturability performance.

• Process Development: Partner in developing and optimizing manufacturing processes, including powder mixing, blending, granulation, compression, and encapsulation, to help define critical quality attributes (CQAs) and critical process parameters (CPPs).

• Scale-Up Support: Partner in formulation and process scale-up efforts from lab scale to pivotal and commercial scales, assisting with seamless technology transfer to CMO partner sites.

• Project Team Participation: Participate in weekly or bi-weekly NBI-CMO project team meetings and provide Pharm Dev-specific updates on progress.

• Regulatory Documentation: Contribute to authoring and reviewing sections of drug product documentation to support various regulatory submissions.

• Deviation Investigation: Support investigations as a subject matter expert