Scientist, Immunogenicity Bioanalytical
Amgen · Thousand Oaks, CA
ResearchFull-timeCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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