Sr. Scientist, CMC Analytical Development

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.

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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• 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

• 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

• May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams

• Excellent communications, problem-solving, analytical thinking skills

• Sees broader picture and longer-term impact on division/company.

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent project management, strong project leadership skills

• Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development

• Experience and expertise with gene therapy and/or biologic compounds, including potency assay development, cell line banks, plasmids, and viral vector (AAV) analysis

• Excellent interpersonal skills with strong oral and written communication abilities

• Excellent laboratory and productivity skills

• Proficient in characterization of gene therapy and/or biologic compounds using various modern technologies. They may include but not limited to ddPCR, NGS, ELISA, high resolution MS, cell-based potency assays, HPLC, and CE

• Method development, validation, and transfer experience in Analytical Development

• Comprehensive understanding of cGMP requirements in API and drug product

• Expert knowledge of cross-functional understanding related to drug development

• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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