Bioanalytical Scientist
virtual vocationsNew York, NY
Bioanalytical Scientist
virtual vocationsNew York, NYSenior L5
Research and Development in Biotechnology (except Nanobiotechnology)In-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
APPLY NOWServing 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 lifecycleRequired 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
Matching similar jobs
Level
Senior L5
Location
New York, NY
Occupation
Biological Scientists, All Other
Industry
Research and Development in Biotechnology (except Nanobiotechnology)
Posted
yesterday