Bioanalytical Scientist

Job Summary

Serving as a technical subject matter expert for outsourced methods, the full-time remote Bioanalytical Portfolio Scientist will ensure method validation and optimal performance of immunogenicity assays at contract research organizations (CROs), focusing on anti-drug antibody and neutralizing antibody assays.

Key Responsibilities:

• Provides scientific and technical oversight for the transfer, validation, and execution of immunogenicity assays, ensuring adherence to regulatory expectations and industry best practices
• Leads the transfer and validation of assays at external CROs and collaborates with internal experts to ensure successful assay execution
• Monitors assay performance and contributes to troubleshooting and continuous improvement efforts while managing the method lifecycle

Required Qualifications:

• Doctorate degree, or Master's degree with 2 years of regulated scientific laboratory experience, or Bachelor's degree with 4 years of regulated scientific laboratory experience
• Demonstrated expertise in immunoassay development, validation, and troubleshooting for ADA and NAb assays
• Knowledge of current regulatory expectations and industry best practices
• Experience working with contract research organizations (CROs)
• Strong project and people management skills