Bioanalytical Scientist

Posted 9 days ago

virtual vocationsNew York (NY)

Biological Scientists, All Other Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

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About the role

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

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