Sr. Scientist, Analytical Chemistry, CMC

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

About The Role
Neurocrine Biosciences is seeking a highly motivated and experienced Sr. Scientist, Analytical Development, to support small-molecule pharmaceutical development Chemical Development within our CMC team. The successful candidate will lead multiple analytical projects with minimal supervision and perform laboratory experiments to support both early- and late-stage programs.

This role involves close collaboration with global Contract Manufacturing Organizations (CMOs) to ensure the development, transfer, and validation of analytical methods for regulatory starting materials, intermediates, and active pharmaceutical ingredients (APIs). Key responsibilities include method development and validation, troubleshooting out-of-specification (OOS) and out-of-trend (OOT) results, contributing to regulatory submissions, and ensuring analytical readiness in a fast-paced environment.

Proficiency in HPLC, mass spectrometry (MS), and Headspace GC is essential. The ideal candidate is a technically strong leader, an effective communicator, and a collaborative team player who thrives in a dynamic, well-equipped laboratory setting.

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Your Contributions (include, But Are Not Limited To)

• 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

Requirements

• BS/BA in Analytical Chemistry or related field with 10+ years of relevant pharmaceutical R&D or QC experience
• MS/MA in Analytical Chemistry with 8+ years of relevant industry experience
• Ph.D. in Analytical Chemistry with 5+ years of relevant industry experience
• Strong hands-on experience with HPLC and related troubleshooting
• Practical knowledge of MS, GC, and other analytical instrumentation
• 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
• Experience authoring and contributing to regulatory filings such as INDs, NDAs, IMPDs, and CTAs
• Familiarity working with international CMOs and external testing labs
• Project management experience and a proactive, problem-solving mindset

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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The annual base salary we reasonably expect to pay is $108,600.00-$148, Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.