Scientist/Sr. Scientist, Analytical Development

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 Biosciencesis 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, , and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)About the Role:An Analytical Scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. Responsible for performing analytical laboratory activities to support manufacturing of drug products intended for use in clinical studies (all phases). Develops, establishes, and validates testing methodology used to control final drug 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):Responsible for in-house analytical development laboratory activities to support manufacturing of drug products intended for use in clinical studiesResponsible for conducting in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability, etc.)Work closely with Pharmaceutical Development counterpartsDevelops and validates test methods at NBI for solid oral drug productsSupports formulation developmentIdentification of degradants in drug productAnalytical 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 and3+ years of similar experience noted above ORPhD or equivalent in chemistry or closely related field and some relevant experience; may include postdoc experienceEffective report writing and oral presentations skills are requiredExcellent written and verbal communication skills are requiredMust 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 of the following scientific disciplines: HPLC analytical development and/or dissolution developmentStrong knowledge of scientific principles, methods, and techniquesStrong knowledge and demonstrated ability working with a variety of laboratory equipment/tools, primarily HPLC/UHPLC, Karl Fischer, and dissolution apparatus (manual and automated)Strong laboratory documentation, in line with cGMP practicesAbility to work as part of a teamAbility to lead teamsExcellent computer skillsStrong communication, problem-solving, and 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 skillsLI-OB1Neurocrine 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 $108,600.00-$157,350.00. 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. #J-18808-Ljbffr

Created: 2025-09-17