Sr. Scientist, Analytical Chemistry, CMC

Sr. Scientist, Analytical Chemistry, CMC page is loaded## Sr. Scientist, Analytical Chemistry, CMCremote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Yesterday job requisition :
R5878##

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 ,  and . (
* in collaboration with Abb Vie*)
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* 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.

## 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…