Scientist, Analytical Development
- California, Maryland, United States
- California, Maryland, United States
About
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: This position will serve as analytical SME to support Biologics (such as antibody, bioconjugates) CMC development. Develop, establish, and qualify/validate analytical methods used to monitor the critical product quality of drug substance and drug product. Contribute to the development and implementation of analytical development strategies and workflows. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of process intermediate, drug substance, drug product at all stages of development process._
Your Contributions (include, but are not limited to):Lead analytical method development and qualification/validation activities for the characterization of antibody and antibody conjugate utilizing various analytical techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, Bioassays (ELISA, cell based assays), qPCR, LC-MS, NGS
Support cell line development to enable faster and informed decision making when needed. Key analytical areas for cell line development include but are not limited to high throughput titer analysis, purity analysis, N-glycan analysis, charge variant analysis, sequence variant analysis, genomic integrity analysis
Represent analytical development on CMC cross-functional teams and maintain accountability for analytical deliverables
Lab Personnel and ensure laboratory safety practices
Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed
Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
Other duties as assigned
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
Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
Extensive experience and expertise with antibody modalities, focusing on analytical development
Proficient in characterization of antibody modalities using various analytical technologies including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, molecular analysis (southern blot, northern blot, NGS, etc.)
Method development, qualification, validation, and
Languages
- English
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