Analytical Development Stability Manager

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:

Independently manages multiple stability programs with high complexity for development stage pharmaceutical compounds (drug substances and drug products). Reviews stability protocols, reports, and data from internal labs and contract service organizations (CSOs). Supports shelf-life/retest dating, data trending, and specification revision for drug substances and drug products. Coordinates internal stability samples for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees.

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

• Responsible for resource allocation to achieve team objectives and goals

• Develops and evaluates personnel to ensure the efficient operation of the function

• Manages multiple stability programs independently for development-stage pharmaceutical products (drug substances and drug product) for ICH, bulk hold, patient in-use, cycling studies, etc.:

  • Tracks stability test schedules at contract service organizations (CSOs)

  • Reviews and/or approves stability protocols

  • Reviews, summarizes, and trends stability data with statistical software such as SLIMStat

  • Determines shelf life or retest periods

  • Generates stability protocols, reports, and presentations

• Ability to lead multiple stability programs with moderate to high complexity within CMC

• Coordinates communication with internal customers and external vendors

• Coordinates internal stability samples for storage and testing

• Reviews and approves specifications, change controls, out-of-specification (OOS), out-of-trend (OOT) and deviation reports

• Facilitates and leads investigations for out of specification and out of trend results in stability studies

• Authors and/or reviews Department SOPs re