Bioanalytical Portfolio Scientist
Amgen · Remote
ResearchRemoteFull-timeCompany career page
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Role summary
Amgen seeks a Bioanalytical Portfolio Scientist to provide technical oversight of outsourced immunogenicity assays at contract research organizations. The role involves method validation, performance monitoring, and regulatory compliance for anti-drug antibody and neutralizing antibody studies.
What they're looking for
- Doctorate degree, or Master's degree with 2+ years regulated laboratory experience, or Bachelor's degree with 4+ years regulated laboratory experience
- Demonstrated expertise in immunoassay development, validation, and troubleshooting for ADA and NAb assays
- Knowledge of current regulatory expectations, industry best practices, and scientific guidance
- Experience working with contract research organizations
- Project and people management capabilities
- Excellent written and verbal communication skills
- Strong collaboration and issue resolution abilities
What you'll be doing
- Provide scientific and technical oversight for immunogenicity assay transfer, validation, and execution at external CROs
- Lead assay transfer and validation efforts while monitoring performance over time and troubleshooting issues
- Review analytical data, protocols, validation reports, and study documentation for accuracy and regulatory compliance
- Manage method lifecycle including validation plans, reagent qualification, and continuous improvement initiatives
- Collaborate with internal experts and cross-functional CRO partners for issue resolution and supplier evaluation
Privacy & handoff
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