Senior Scientist – Bioanalysis

Position Summary We 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 Development • Design, 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 precipitation • Solid phase extraction (SPE) • Liquid-liquid extraction (LLE) • Immunoaffinity enrichment • Hybrid workflows • Optimize chromatographic methods using UHPLC/HPLC systems. • Perform method qualification/validation according to regulatory expectations. Mass Spectrometry Expertise • Operate and maintain tandem quadrupole and high-resolution mass spectrometers such as: • Sciex • Thermo Fisher Orbitrap • Q-TOF • Triple Quad systems • Waters Xevo • Optimize: • Ionization conditions • MRM transitions • Sensitivity/selectivity • Matrix effect mitigation • Stability assessments • Investigate assay performance issues and implement corrective actions. Study Support & Sample Analysis • Conduct 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 & Innovation • Evaluate 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 Collaboration • Collaborate with: • DMPK • Toxicology • Clinical Pharmacology • Translational Sciences • Biomarker teams • Discovery Biology • Participate in project team meetings and provide scientific guidance. • Act as BA/Biomarker lead on multidisciplinary study teams. CRO & External Collaboration • Manage external CRO activities. • Review protocols, reports, and method transfer documentation. • Ensure successful technology transfer and assay reproducibility. • Troubleshoot external study challenges. Communication & Reporting • Present scientific findings to leadership and project teams. • Maintain accurate documentation and compliance standards. • Monitor industry trends and emerging technologies. Required Qualifications Education One of the following: • Bachelor’s degree in Life Sciences, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 6+ years experience • Master’s degree with 4+ years experience • PhD with relevant postdoctoral or industry experience Required Technical Skills Core Skills • LC-MS/MS • High Resolution Mass Spectrometry (HRMS) • Biomarker assay development • Bioanalytical method development • Sample preparation techniques • HPLC/UHPLC • PK/PD analysis • Assay troubleshooting • Method validation • Quantitative bioanalysis Preferred Skills • GLP/GCP/GCLP familiarity • Experience with biologics and emerging modalities • Oligonucleotide bioanalysis • Proteomics/metabolomics • Immunoassays • Data analysis software: • Analyst • Xcalibur • MassHunter • Skyline • Watson LIMS • Statistical/data visualization tools