TEMP - Scientist, Analytical Chemistry, CMC

TEMP - Scientist, Analytical Chemistry, CMC page is loaded## TEMP - Scientist, Analytical Chemistry, CMCremote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Todayjob requisition :
R6313##

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*)##

About the Role:

The successful candidate will independently conduct laboratory experiments in support of Chemical Development projects. Initially, analytical support will be provided to the Neurocrine late-stage program working collaboratively with international CMC Analytical development and other teams ensuring methods for regulatory starting materials and intermediate methods are ready for validation at these organizations. In addition to familiarity with headspace GC, modern HPLC, and MS, the individual selected to fill this role must work collaboratively with his or her peers in large open well equipped analytical labs.

The individual who is hired is expected to effectively document research and conduct work in a safe manner in accordance with company, departmental, and regulatory guidelines. ## Your Contributions (include, but are not limited to):
* Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials
* Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
* With supervision, plans and executes in-house stability studies for drug substance’s, 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
* With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development
* 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 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## Requirements:
* BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR
* MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above OR
* PhD in chemistry or closely related field and some industry or relevant experience a plus
* Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation
* Practical working knowledge of conducting HPLC analysis and troubleshooting
* Some expertise in evaluating analytical data and drawing meaningful conclusions
* Knowledge of cGMP expectations for laboratory records and quality systems
* Ability to provide ideas for process improvements
* Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
* Begins to understand how to think outside of the technical process and…