Immunogenicity Bioanalytical Portfolio Scientist

Amgen; United States; Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits

Stock-based incentives

Generous time-off

Flexible work model

Job summary

Amgen is seeking a Bioanalytical Portfolio Scientist to serve as the technical SME for outsourced bioanalytical methods and ensure robust method validation and performance at CROs.

The role oversees immunogenicity assays (ADA and NAb) and ensures adherence to validated methods, data integrity, and GLP/GCP standards. It requires experience with method development, validation, and troubleshooting, plus strong communication and collaboration skills.

Qualifications

• Doctorate (PhD) required.
• Master’s degree with 2+ years regulated lab experience or Bachelor’s with 4+ years regulated lab experience.
• Experience with immunogenicity assays (ADA and NAb) and regulatory guidance is preferred.

Responsibilities

• Provide scientific and technical oversight for transfer, validation, and execution of immunogenicity assays at CROs.
• Lead transfer and validation of assays at external CROs.
• Collaborate with internal SMEs to ensure robust assay transfer and validation.
• Monitor assay performance and drive continuous improvement efforts.
• Review method validation plans, protocols, reports, and reagents qualification in GLP/GCP context.
• Navigate CRO interactions and governance for issue resolution.
• Support regulatory activities and supplier evaluations.

Skills

Immunoassay development

CROs experience

Project management

Communication skills

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Job description

Amgen is seeking a Bioanalytical Portfolio Scientist to serve as the technical SME for outsourced bioanalytical methods and ensure robust method validation and performance at CROs.

The role oversees immunogenicity assays (ADA and NAb) and ensures adherence to validated methods, data integrity, and GLP/GCP standards. It requires experience with method development, validation, and troubleshooting, plus strong communication and collaboration skills.