Scientist, Bioanalytical Sciences

Role: Bioanalytical Scientist specializing in oversight of outsourced bioanalytical assays for pharmacokinetic (PK) and toxicokinetic (TK) studies at a biopharma focused on Oncology, Inflammation, and Rare Diseases. Objectives: ensure assay transfer, validation, and performance adherence to GLP/GCP standards, supporting regulatory compliance and scientific integrity. Responsibilities: oversee PK/TK method transfer and validation using ligand-binding assays and LC-MS; collaborate with CROs and internal teams to monitor assay performance, troubleshoot issues, and manage the assay lifecycle; review validation plans, reports, and study documentation; support regulatory submissions and audits. Requirements: Doctorate or Master’s with relevant experience, or Bachelor’s with extensive regulated lab experience; strong background in PK assay development, validation, and troubleshooting; expertise in ligand-binding assays, LC-MS bioanalysis, and regulatory guidance (FDA, ICH, EMEA, NMPA); experience working with CROs, project management, and excellent communication skills. Preferred: demonstrated PK assay expertise, knowledge of regulatory standards, project/people management, and cross-functional collaboration skills. High-Value: focus on bioanalytical sciences within clinical or preclinical phases, supporting GLP/GCP compliance, working with external CROs, and contributing to regulatory activities in a collaborative, innovative environment. Work Setup: not specified; emphasis on cross-functional teamwork and external oversight.