Immunogenicity Bioanalysis Lead

Amgen Inc. (IR); Northern (KY); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Job summary

Amgen Inc. (IR) is seeking a Bioanalytical Portfolio Scientist to provide scientific and technical oversight of outsourced immunogenicity methods, including ADA and NAb assays.

You will manage transfer and validation at CROs, ensuring adherence to validated methods and regulatory expectations, while collaborating with internal experts for successful assay lifecycle management. The role emphasizes strong communication, project leadership, and experience with regulated bioanalytical work in

Qualifications

• Doctorate or Master/Bachelor with required regulated lab experience per basic qualifications.
• Expertise in immunogenicity assay development and validation.
• Ability to troubleshoot ADA and NAb assays and work with CROs.

Responsibilities

• Provides scientific and technical oversight for transfer, validation, and execution of immunogenicity assays (ADA and NAb).
• Leads transfer and validation of assays at external CROs and ensures GLP/GCP compliance.
• Collaborates with internal bioscience SMEs to understand assay attributes and ensure successful transfer.
• Monitors assay performance over time and contributes to troubleshooting and improvements.
• Oversees method lifecycle, validation plans, protocols, and reagent qualification.
• Reviews data, protocols, and reports for scientific accuracy and GLP/GCP consistency.
• Works with CROs to resolve issues and escalate within governance structures.
• Provides SME input during supplier evaluation and monitoring activities.

Skills

Immunoassay development

Validation

Troubleshooting ADA/NAb assays

CRO management

Project management

Written and verbal communication

Education

Doctorate degree

Master's degree with 2 years of regulated scientific laboratory experience

Bachelor's degree with 4 years of regulated scientific laboratory experience

Job description

Amgen Inc. (IR) is seeking a Bioanalytical Portfolio Scientist to provide scientific and technical oversight of outsourced immunogenicity methods, including ADA and NAb assays.

You will manage transfer and validation at CROs, ensuring adherence to validated methods and regulatory expectations, while collaborating with internal experts for successful assay lifecycle management. The role emphasizes strong communication, project leadership, and experience with regulated bioanalytical work in