Principal Scientist, 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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Develop and execute analytical methods using a range of techniques including HPLC/UPLC, HRMS, GC, HS-GC, MS, IC, NMR, TGA, DSC, PXRD, PSD, KF, and FTIR for drug substances, intermediates, raw materials, and developmental compounds

• Lead analytical method development, validation, and troubleshooting under minimal supervision

• Conduct and document investigations related to OOS, OOT, or anomalous results

• Author analytical sections of regulatory submissions (e.g., NDA, IND, IMPD, CTA) in alignment with global regulatory guidelines and internal quality standards

• Perform in-silico assessments for potential mutagenicity and Nitrosamine CPCA risk, following current regulatory guidance

• Provide technical leadership and mentorship to junior scientists to foster scientific growth and ensure high-quality output

• Collaborate cross-functionally with chemical and formulation development teams to design and execute analytical studies

• Ensure compliance with SOPs, data integrity policies, and regulatory requirements through meticulous documentation and recordkeeping

• Review and approve internally generated and externally sourced analytical data

• Plan and execute in-house stability studies for APIs, intermediates, and prototype drug products

• Coordinate instrument maintenance and service; perform routine upkeep as trained

• Support laboratory operations, including inventory control and glassware management

• Actively contribute to a culture of continuous improvement, scientific excellence, and operational efficiency

• Perform other duties as assigned

• BS/BA in Chemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR

• MS/MA in Chemistry or related discipline and 10+ years of experience OR

• PhD in Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience

• Experience authoring and contributing to regulatory filings such as INDs, NDAs, IMPDs, and CTAs

• Familiarity working with international CMOs and external testing labs

• Strong hands-on experience with HPLC and related troubleshooting

• Practical knowledge of MS, GC, and other analytical instrumentation

• Project management experience and a proactive, problem-solving mindset

• Understanding of cGMP standards and regulatory requirements for analytical method development and documentation

• Proficiency in data acquisition and analysis software, as well as Microsoft Office applications

• Demonstrated ability to analyze and interpret complex data sets and draw scientifically sound conclusions

• Solid foundation in analytical chemistry principles and laboratory practices

• Excellent attention to detail, organizational skills, and ability to manage multiple priorities

• Strong written and verbal communication skills, with the ability to work independently and in collaborative teams

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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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