Senior Principal Scientist, CMC Downstream Gene Therapy Development

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:

Responsible for research and development, tech transfer and commercialization of drug substance processes, as well as oversight of batch manufacturing and regulatory document contribution through managerial and individual input. Provides project management for CMC programs or Chemical Development projects. Manages direct reports.

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

• Provides leadership for exploratory development of biologics and AAV gene therapy purification including all aspects of downstream process and the associated analytical development in a research & development environment

• Experienced in the development, implementation, and manufacturing of biologics and AAV drug substances for pre-clinical and clinical trial use

• Drives for exploratory process development for therapeutic antibodies including all aspects of downstream production in a research environment

• Guides implementation of downstream suspension-based platform processes for the generation of material as well as the early optimization studies, working with a downstream and analytical team for the characterization and release testing to support research, pre-clinical, and IND-enabling studies

• Leads the additional process development activities to support development candidates and activities for timely IND, BLA and all relevant ex-US regulatory filings

• Collaborates with discovery research and product development to build the scientific knowledge, capabilities, and strategies in biotherapeutic, protein and gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization

• Actively implements science-driven, phase appropriate, and risk-based process development strategies to enable further development from candidate nomination to clinical development and commercial manufacture

• Identifies and resolves technical problems through scientific understanding, options assessment, and application of innovative solutions