Who We Are:Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)About the Role:Analytical project leader responsible in performing analytical chemistry research to develop assays based on new and existing methodologies. Responsible for all analytical activities for an assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases). Develops, establishes and validates testing methodology used to control raw materials, production intermediates and final products. Establishes, validates and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements._Your Contributions (include, but are not limited to):Act as an analytical project leaderResponsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases)Develops and validates test methods at NBI for drug substances (API), intermediates and drug productSupports chemical development and formulation developmentPreformulation collaboration to Pharmaceutical SciencesTests and provides a complete characterization of toxicology suppliesStructural characterization of drug substance molecules, identification of impurities/degradants in API and drug productAudits and selects contract service providers (CSP) to conduct GMP analytical testing for Neurocrine projectsAnalytical technology transfer to CSPOverviews GMP analytical testing of clinical supplies by CSPsFacilitates and leads investigations for out of specification and out of trend resultsPrepares of the analytical sections of regulatory documents, protocols and reportsProvides training and/or supervision to junior staff, as neededOther duties as assignedRequirements:BS/BA degree in chemistry or closely related field AND 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry. Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms. Previous supervisory and/or project management experience is preferred. ORMS/MA degree in chemistry or closely related field AND 3+ years of similar experience noted above ORPhD or equivalent in chemistry or closely related field AND some relevant experience; may include postdoc experienceMust be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the companyAbility to creatively solve complex problems in a team environmentDemonstration of cross-functional understanding related to drug developmentEffectively see projects to completionUnderstands how to effectively negotiate, persuade, and influenceExtensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage formsA working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issuesMust have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTDDemonstrates solid level of understanding project / group goals and methodsConsistently recognizes anomalous and inconsistent results and interprets experimental outcomesAble to explain the process behind the data and implications of the resultsStrong knowledge of one or more scientific disciplines, becoming expert in one disciplineStrong knowledge of scientific principles, methods and techniquesStrong knowledge and demonstrated ability working with a variety of laboratory equipment/toolsAbility to work as part of a team; may train lower levelsAbility to leading teamsExcellent computer skillsStrong communications, problem-solving, analytical thinking skillsDetail oriented yet can see broader picture of scientific impact on teamAbility to meet multiple deadlines, with a high degree of accuracy and efficiencyStrong project management skillsEffective report writing and oral presentations skills are requiredExcellent written and verbal communication skills are required#LI-LS1Neurocrine 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._The annual base salary we reasonably expect to pay is $110,800.00-$151,000.00. 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 20% 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.