Senior Scientist – Bioanalysis
Position SummaryWe are seeking a highly motivated Bioanalytical and Biomarker Scientist to support discovery and development programs through the design, development, qualification, troubleshooting, and implementation of bioanalytical and biomarker assays using LC-MS/MS and high-resolution mass spectrometry platforms. The successful candidate will play a critical role in evaluating novel analytical technologies, developing robust methodologies, interpreting complex datasets, and collaborating with cross-functional teams to advance therapeutic candidates from early discovery through development.The ideal candidate possesses deep expertise in mass spectrometry-based bioanalysis, sample preparation, chromatography, assay development, biomarker analysis, and regulated/non-regulated bioanalytical workflows. Experience supporting small molecules, biologics, peptides, oligonucleotides, antibody-drug conjugates (ADCs), or other emerging modalities is highly desirable.Key Responsibilities (Detailed)Bioanalytical & Biomarker Method DevelopmentDesign, optimize, validate, and troubleshoot LC-MS/MS and HRMS-based bioanalytical assays for quantitative and qualitative analysis.Develop biomarker assays supporting translational and preclinical/clinical studies.Establish robust sample preparation strategies including:Protein precipitationSolid phase extraction (SPE)Liquid-liquid extraction (LLE)Immunoaffinity enrichmentHybrid workflowsOptimize chromatographic methods using UHPLC/HPLC systems.Perform method qualification/validation according to regulatory expectations.Mass Spectrometry ExpertiseOperate and maintain tandem quadrupole and high-resolution mass spectrometers such as:SciexThermo Fisher OrbitrapQ-TOFTriple Quad systemsWaters XevoOptimize:Ionization conditionsMRM transitionsSensitivity/selectivityMatrix effect mitigationStability assessmentsInvestigate assay performance issues and implement corrective actions.Study Support & Sample AnalysisConduct bioanalytical sample analysis for discovery, preclinical, and clinical studies.Interpret PK/PD and biomarker data.Review analytical datasets and ensure data integrity.Prepare technical reports, summaries, SOPs, and study documentation.Support regulated and exploratory studies.Scientific Leadership & InnovationEvaluate emerging technologies and novel analytical platforms.Introduce innovative workflows to improve assay sensitivity, throughput, and robustness.Serve as subject matter expert (SME) for bioanalytical sciences.Mentor junior scientists and contribute to scientific strategy.Cross-functional CollaborationCollaborate with:DMPKToxicologyClinical PharmacologyTranslational SciencesBiomarker teamsDiscovery BiologyParticipate in project team meetings and provide scientific guidance.Act as BA/Biomarker lead on multidisciplinary study teams.CRO & External CollaborationManage external CRO activities.Review protocols, reports, and method transfer documentation.Ensure successful technology transfer and assay reproducibility.Troubleshoot external study challenges.Communication & ReportingPresent scientific findings to leadership and project teams.Maintain accurate documentation and compliance standards.Monitor industry trends and emerging technologies.Required QualificationsEducationOne of the following:Bachelor's degree in Life Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 6+ years experienceMaster's degree with 4+ years experiencePhD with relevant postdoctoral or industry experienceRequired Technical SkillsCore SkillsLC-MS/MSHigh Resolution Mass Spectrometry (HRMS)Biomarker assay developmentBioanalytical method developmentSample preparation techniquesHPLC/UHPLCPK/PD analysisAssay troubleshootingMethod validationQuantitative bioanalysisPreferred SkillsGLP/GCP/GCLP familiarityExperience with biologics and emerging modalitiesOligonucleotide bioanalysisProteomics/metabolomicsImmunoassaysData analysis software:AnalystXcaliburMassHunterSkylineWatson LIMSStatistical/data visualization tools