Bioanalytical Portfolio Scientist Job at Amgen, Remote

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  • Amgen
  • Remote

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Job Tags

Contract work

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