Sr. Scientist, CMC Analytical 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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

This position will serve as the analytical lead for multiple projects, with a focus on gene therapy and biologics. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify testing methods used to control raw materials, in process, intermediates, API, and drug products. Contribute to the development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

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

• Lead analytical development work for multiple projects, primarily gene therapy compounds, including cell banks, plasmids, viral vectors, and residual host cell proteins/DNA. Represent Analytical Development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects

• Design, plan, and execute activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities

• Guide laboratory work and/or lab personnel within the company and at external vendors

• Ensure safe laboratory practices

• Perform analytical development and method optimization in support of preclinical through commercialization

• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development

• Support off-site analytical transfers, manufacturing support, and interaction with contractors

• Provide input into CMC regulatory documentation and supporting work

• Leverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategies

• Contribute to development of policies and department strategies

• Build and enhance internal and external professional relationships

• Support career development and technical growth of team members

• Present finding at varying levels across the company

• Other duties as assigned

Requirements:

• BS/BA and 5+ years of experience OR

• MS/MA and 3+ years of experience OR

• PhD or equivalent and some relevant experience; may include post-doc experience

• Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas

• Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects

• Leads the development of intellectual property<