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.
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)
Responsible for analytical development to support research and development, tech transfer and characterization of biologics drug substance and drug product processes including cell-line development, as well as of batch or sample testing/release/stability and regulatory document contribution. Provides project management and coordination for analytical in support of projects at various stages of development. Provides analysis and evaluation of biologics material and products at all stages of the development process. Monitors and evaluates completion of tasks and projects.
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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 in Chemistry/ Biochemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Development OR
MS/MA in Chemistry or related discipline and 10+ years of experience OR PhD in Chemistry/ Biochemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
Thorough understanding of analytical chemistry & method development for biologics and a well-developed understanding of biologics process development (cell-line, upstream and downstream), and drug product development
Hands on experience and strong expertise with biologics impurities method development. Required skills include but are not limited to qPCR, ddPCR, ELISA, and western blot
Proficiency to advance program as analytical development lead
Excellent interpersonal skills with strong oral and written communication abilities
Excellent laboratory and productivity skills
Method transfer experience in Analytical Development
Good understanding of cGMP requirements in drug substance and drug product
Demonstration of cross-functional understanding related to biologics drug development
Assimilates data and research findings outside of Neurocrine for application to new scientific projects
Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
May develop an understanding of other areas and related dependencies
Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent computer skills
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture, impact on multiple programs, teams and/or departments
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management skills
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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 $130,800.00-$179,000.00. 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 30% 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.
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.
Review our Community Guidelines: https://bit.ly/NeurocrineLinkedInGuidelines
*in collaboration with AbbVie
