Principal Scientist, Product Development – 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:

Develop, design and execute formulation and process related studies to support development projects from Phase I through commercial. Manage, with an enabled formulation slant, full product development programs from excipient compatibility through process validation, including formulation screening and prototyping, scale-up and optimization, packaging, packaging and stability testing of drug products. Establish CMO relationships to support clinical programs. Oversee process development and 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.
Key areas of focus include: solubility enhancement, modified release dosage forms, amorphous solid dispersions (Spray Drying and Hot Melt Extrusion), self-emulsifying drug delivery systems (SEDDS), low dose/drug load product design, dry granulation, tableting, and encapsulation.

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

• Develop and optimize phase-appropriate formulations (and processes) to meet target product profile and project needs

• 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

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

• Identify, evaluate, and ensure outsourcing partners have the required expertise, capabilities, and quality/compliance standards to support drug product formulation development and process development, method development, manufacturing and packaging

• Research new instrumentation, equipment, and formulation technologies to be implemented when needed for development of target formulations

• Present updates at department meetings and deliver scientific talks on current and new techniques/technology