Bioanalysis Scientist I

Role: Bioanalytical scientist specializing in large molecule biotherapeutics, supporting preclinical and clinical drug development through method development, validation, and sample analysis. Responsibilities: develop and validate assays (e.g., immunoassays, genomics platforms) for biomarkers, proteins, peptides, monoclonal antibodies, and oligonucleotides; ensure compliance with GxP and regulatory standards; troubleshoot and optimize complex bioanalytical methods; collaborate with internal teams and clients; author technical documents; mentor junior staff; and contribute to scientific presentations and publications. Requirements: Ph.D. or MSc in immunology, cell biology, molecular biology, biochemistry, or related field; 3-5 years bioanalytical experience in CRO environment; expertise with biologics, biomarkers, cell and gene therapy, PK, ADA, NAb assays; proficiency with genomics and ligand binding platforms; knowledge of GxP/GLP/GCP/GMP; strong communication, project management, and collaboration skills; proficiency with LIMS and data analysis tools. High-Value: focus on large molecules, cell and gene therapy, biomarker development, GxP compliance, and regulatory audits. WorkSetup: not specified, but laboratory environment emphasized.