Associate Scientific Director, Analytical Development

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 patients with 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:This position will serve as a subject matter expert and analytical liaison for research and early-stage development projects, with a focus on mass spectrometry characterization of antibodies, conjugates, and other large molecules. Evaluate the developability of development candidates by performing structure elucidation, chemical stability assessments, and forced degradation studies. Accumulate product and process understanding to guide lead-optimization, process development, and formulation development. Serve as Analytical Development Lead and support and oversee all the analytical activities related to drug substance and drug product development from preclinical through commercial phases, including method development, validation/qualification, specification establishment, and control strategy development. Contribute to biomarker discovery via proteomics analysis and targeted quantification across modalities and functional areas. Responsible for keeping work in compliance with GxP, safety, and regulatory requirements. Contribute to analysis and evaluation of material and products at all stages of development process. Supervise junior scientists through coaching and evaluating completion of tasks and projects._Your Contributions (include, but are not limited to):Establish collaborative and productive working relationships with key partner organizations to build cross-project analytical alignment and consistent developability criteria through a matrix, cross-functional analytical characterization strategy aligned with broader business objectivesDefine discovery-stage critical quality attributes (CQAs) aligned with target product profiles (TPPs) to guide molecule engineering and optimization, support risk-based developability assessment, and establish early product and process understandingEvaluate development candidate developability by performing structure elucidation, chemical stability and forced degradation studies. Collect developability and characterization data to guide lead-optimization within Research, process and formulation development within Technical OperationsServe an Analytical Lead in leading analytical development activities for the characterization of antibodies and other large molecules utilizing LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis, HPLC, and modern glycoprotein & carbohydrate characterization techniquesLead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercializationRepresent Analytical Development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projectsDirect laboratory work and/or lab personnel within the company and at external vendorsEnsure safe laboratory practicesProvide input into CMC regulatory documentation and supporting workLeverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategiesContribute to development of policies and department strategiesBuild and enhance internal and external professional relationshipsPartner cross-functionally with Biologics Research, Pharmacology, Translational Sciences, DMPK, Toxicology, Clinical Development, Project Leadership, and Business Development to advance programs and inform strategic decision-makingSupport career development and technical growth of team membersPresent finding at varying levels across the companyOther duties as assignedRequirements:BS/BA and 15+ years of experience, ORMS/MA and 13+ years of experience, ORPhD or equivalent and 10+ years of relevant experienceDeep expertise in MS-based primary and higher-order structure characterization, physicochemical and biophysical analysis, spectroscopy, and thermodynamic/hydrodynamic characterization, with demonstrated ability to link molecular attributes to stability, efficacy, and biological functionExperience and expertise with antibody, conjugates, and/or peptides compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterizationExcellent interpersonal skills with strong oral and written communication abilitiesExcellent laboratory and productivity skillsProficient in characterization of antibody and/or peptides compounds using various modern technologies. They may include but not limited to various Mass Spectrometry technologies, LC-MS, HPLC, Capillary Electrophoresis, peptide mapping, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization cell-based potency assaysMethod development, validation, and transfer experience in Analytical DevelopmentComprehensive understanding of cGMP requirements in API and drug productExpert knowledge of cross-functional understanding related to drug developmentKnowledge of FDA, EMA, WHO, and ICH regulatory requirementsApplies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areasMaintains substantial knowledge of principles and theories and acts as a technical lead on various projectsLeads the development of intellectual propertyMay utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problemsAbility to work as part of and lead multiple teamsGood leadership, mentoring skills and abilities typically leads lower levels and/or indirect teamsExcellent communications, problem-solving, analytical thinking skillsSees broader picture and longer-term impact on division/companyAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management, strong project leadership skills#LI-DM1Neurocrine 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 $173,600.00-$237,000.00. 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. #J-18808-Ljbffr Neurocrine Biosciences