Job Details

A company is looking for a Bioanalytical Portfolio Scientist to oversee outsourced bioanalytical methods and ensure optimal method performance.Key ResponsibilitiesProvide scientific and technical oversight for the transfer, validation, and execution of pharmacokinetic (PK) assaysLead the transfer and validation of PK assays at external CROs using various methodologiesMonitor assay performance and contribute to troubleshooting and continuous improvement effortsRequired QualificationsDoctorate degree OR a Master's degree with 2 years of regulated commercial scientific laboratory experience OR a Bachelor's degree with 4 years of experience OR an Associate's degree with 8 years of experience OR a high school diploma/GED with 10 years of experienceDemonstrated expertise in PK assay development, validation, and troubleshootingKnowledge of current relevant regulatory guidance and regulations (e.g., FDA, ICH, EMEA, NMPA)Experience working with contract research organizations (CROs)Strong project management experience