Principal Scientist, Prod Dev - Late Stg

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:

Design, develop and execute formulation and process design & engineering to support development projects from Phase I through commercial. Manage, with a Quality by Design (QbD) mindset, 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. This role involves designing and implementing innovative formulation strategies and robust process engineering to ensure product quality, scalability and regulatory compliance. Establish CDMO relationships to support clinical programs. Oversee successful technical transfer for Neurocrine drug products to CDMOs. Represent CMC 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):

• Design and develop robust formulations for solid oral dosage forms (e.g. tablets, capsules), optimizing for stability, bioavailability and manufacturability using QbD principles

• Develop and optimize manufacturing processes, including but not limited to powder mixing/blending, granulation, compression, coating and encapsulation to define critical quality attributes (CQAs) and critical process parameters (CPPs)  

• Lead formulation and process scale up from lab scale to pivotal and commercial scales ensuring seamless technology transfer to CMO partner sites

• Participate and/or lead weekly or bi-weekly NBI-CMO project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines

• Author and review Module 3 sections of drug product to support various regulatory submissions

• Participate and/or lead investigations as a SME where applicable on atypical or aberrant results on projects ranging from pre-formulation through to commercial

• Identify, evalua