Bioanalytical Portfolio Scientist

Job Summary

A company is looking for a Bioanalytical Portfolio Scientist to oversee outsourced bioanalytical methods and ensure optimal method performance.

Key Responsibilities

• Provide scientific and technical oversight for the transfer, validation, and execution of pharmacokinetic (PK) assays
• Lead the transfer and validation of PK assays at external CROs using various methodologies
• Monitor assay performance and contribute to troubleshooting and continuous improvement efforts

Required Qualifications

• Doctorate 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 experience
• Demonstrated expertise in PK assay development, validation, and troubleshooting
• Knowledge of current relevant regulatory guidance and regulations (e.g., FDA, ICH, EMEA, NMPA)
• Experience working with contract research organizations (CROs)
• Strong project management experience