TEMP - Scientist, Analytical Chemistry, CMC
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About the role
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 neurocrine.com , and follow the company on LinkedIn , X and Facebook . ( *in collaboration with AbbVie ) Independently conduct laboratory experiments to support small-molecule projects for Chemical Development. The initial focus will be on providing analytical support for a late-stage Neurocrine program, including collaboration with international CMO partners to ensure the development and validation of methods for regulatory starting materials and intermediates. Responsibilities also include troubleshooting out-of-specification (OOS) and out-of-trend (OOT) results. Proficiency in modern HPLC, mass spectrometry (MS), and Headspace GC is essential. Strong team player, contributing effectively in a large, open, and well-equipped analytical laboratory. Excellent documentation practices and a strong commitment to safety and compliance with company, departmental, and regulatory guidelines are required. _ Your Contributions (include, but are not limited to): Develops and executes analytical instrumental methods (e.g., HPLC, GC, HS-GC, MS, NMR, TGA, DSC, PXRD, PSD, KF, and FTIR) of analyses for development compounds, drug substances, raw materials, and intermediates Accurately follows established test methods, procedures, and pharmacopeia chapters to generate data essential for strategic decision making With supervision, plans and executes in-house stability studies for drug substances, intermediates, and prototype drug products With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out-of-specification, out-of-trend, and/or anomalous results Collaboratively plans and executes cross-functional studies for chemical and formulation development under supervision Recognizes and responds to unexpected or anomalous observations in all activities Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training Provides detailed reviews of peer-generated data as well as that generated from contracted service providers Maintains the inventory of laboratory consumables and clean glassware Coordinates vendors' service calls for repair and maintenance of laboratory instruments, with training to perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies Performs other duties as assigned