Bioanalytical Scientist

Job Summary

Serving as the technical subject matter expert for outsourced methods, the full-time remote Bioanalytical Scientist will oversee method validation and performance at CROs, ensuring compliance with GLP/GCP principles and regulatory requirements while providing scientific oversight of bioanalytical activities.

Key Responsibilities:

• Provides scientific and technical oversight for the transfer, validation, and execution of pharmacokinetic (PK) assays
• Leads the transfer and validation of PK assays at external CROs using various methodologies, including ligand-binding and LC-MS/MS
• Monitors assay performance and contributes to troubleshooting and continuous improvement efforts

Required Qualifications:

• Doctorate degree or Master's degree with 2 years of relevant laboratory experience, or Bachelor's degree with 4 years of relevant laboratory experience
• Demonstrated expertise in PK assay development, validation, and troubleshooting
• Knowledge of current regulatory guidance and regulations (e.g., FDA, ICH, EMEA, NMPA)
• Experience working with contract research organizations (CROs)
• Strong project and process management skills