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Neurocrine Biosciences

Principal Scientist, Analytical Development

Neurocrine Biosciences, San Diego, California, United States, 92189


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, but few options.What We Do:Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook.About the Role:Responsible for analytical development to support research and development, tech transfer and commercialization of drug substance and drug product processes, as well as oversight of batch testing/release and regulatory document contribution through managerial and individual input. Provides project management for analytical in support of Chemical and Product Development projects. Provides analysis and evaluation of material and products at all stages of the development process. Monitors and evaluates completion of tasks and projects.Your Contributions (include, but are not limited to):Plans and manages projects. Represents Analytical Development on cross-functional teams. Maintains accountability for analytical deliverables and progress on R&D and manufacturing plans for biologics projects (proteins/peptides/bioconjugates).Independently designs, plans and executes activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities.Supervises laboratory work and/or lab personnel and ensures safe laboratory practices.Performs analytical development and optimizes methods in support of preclinical through commercialization.Creates and implements novel ideas and techniques to support analytical activities with Chemical and Product Development.Provides support for off-site analytical transfers, manufacturing support and interaction with contractors.Provides input into CMC regulatory documentation and supporting work.Provides effective supervision of laboratory personnel and guidance for their professional development.Contributes to development of policies and department strategies.Builds and enhances internal and external professional relationships.Other duties as assigned.Requirements: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 ORMS/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 (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, 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.Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, equitable, and inclusive workplace, 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.The annual base salary we reasonably expect to pay is $125,700.00-$182,250.00. 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.

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