Sr. Scientist/Principal Scientist, Product Development Biologics

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:

The Sr. Scientist/Principal Scientist, Product Development is a highly motivated professional that will perform strategic planning and execution of drug product development and manufacture for its clinical development programs (phase 1, 2, 3), and planned commercial launch, joining its growing and dynamic team. The Sr. Scientist/Principal Scientist, Product Development provides leadership on all aspects of biologics Drug Product (DP) process development, including formulation, process, manufacture for the development programs and corresponding analytical methodologies for different molecular modalities, including peptides, proteins and antibodies through external partners or internal team. The Chemistry, Manufacturing and Controls (CMC) Product Development (PD) team is highly collaborative with an international or domestic network of highly qualified Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company’s effort to discover, develop, and commercialize biopharmaceutical large molecule therapeutics. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in the heart of San Diego’s biotechnology community.

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

• Establish relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc) to support biologics programs - Responsible for all process development-related activities and CMOs results, including Technology Transfer to CMO partner sites for manufacturing of different phases of clinical studies, registration stability lots, and validation batches

• Manage priorities and timelines while also creating value by devising new possibilities for IP, incorporating QbD principles when possible, and practicing the best/most practical technologies

• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages, or other regulatory dossiers)

• Manage assessment capabilities within the Product Development Department,