Scientist, Immunogenicity Bioanalytical
Amgen Inc
Amgen seeks a scientist to develop and validate bioanalytical methods for detecting anti-drug antibodies in drug development programs. The role involves method development, regulatory compliance, data interpretation, and collaboration across functional areas to support immunogenicity assessment throughout the drug lifecycle.
Responsibilities
- Develop and optimize anti-drug antibody and pre-existing antibody assays using platforms such as electrochemiluminescence
- Design and execute method validations following regulatory guidance and internal standards
- Conduct sample analysis and author bioanalytical documents including validation and study reports
- Develop mitigation strategies for complex assay challenges including high drug concentrations and matrix effects
- Provide scientific oversight of bioanalytical work at internal and external laboratories
Requirements
- PhD in relevant field, or Master's degree with 2+ years immunogenicity bioanalytical experience, or Bachelor's degree with 4+ years experience
- Prior pharma or biotech experience strongly desired
- GLP and GCP compliance experience
- Bioanalytical assay execution and method transfer to CRO labs
- Knowledge of immunology, antibody biology, or immunogenicity
- Ability to manage multiple projects in fast-paced environment
- Strong scientific problem-solving and project management skills
Vacancy posted 23 days ago
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