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 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, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Lead analytical development activities for the characterization of antibodies and/or synthetic peptides utilizing HPLC, LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques

• Lead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercialization

• Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects

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

• Ensure safe laboratory practices

• 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 in Analytical Chemistry or related discipline and 15+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR

• MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR

• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience

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

• Experience and expertise with antibody and/or peptides compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterization.

• Excellent interpersonal skills with strong oral and written communication abilities

• Excellent laboratory and productivity skills

• Proficient in characterization of antibody and/or peptides compounds using various modern technologies. They may include but not limited to LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization cell-based potency assays

• 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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