Immunogenicity Bioanalysis Portfolio Scientist

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 109,000 - 147,000; Full time

Job summary

Amgen Inc. (IR) seeks a Bioanalytical Portfolio Scientist to oversee outsourced immunogenicity assay methods, ensuring validation, performance, and regulatory compliance.

You will guide transfer, validation, and ongoing monitoring of ADA and NAb assays via CRO partners, while collaborating with internal experts to maintain data integrity and study quality. The role requires advanced degrees and experience in immunoassay development and CRO management, with strong communication skills and a

Qualifications

• Doctorate degree OR Master’s degree and 2 years of regulated scientific laboratory experience OR Bachelor’s degree and 4 years of regulated scientific laboratory experience.

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.
• Collaborates with internal experts to ensure successful assay transfer and validation.
• Monitors assay performance and supports troubleshooting and continuous improvement.
• Oversees method lifecycle management including validation plans and reports.
• Reviews analytical data and ensures GLP/GCP compliance.

Skills

Immunoassay development

Validation & troubleshooting

Regulatory knowledge

CROs experience

Project management

Communication skills

Cross-functional collaboration

Negotiation

Influencing others

results oriented

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Job description

Amgen Inc. (IR) seeks a Bioanalytical Portfolio Scientist to oversee outsourced immunogenicity assay methods, ensuring validation, performance, and regulatory compliance.

You will guide transfer, validation, and ongoing monitoring of ADA and NAb assays via CRO partners, while collaborating with internal experts to maintain data integrity and study quality. The role requires advanced degrees and experience in immunoassay development and CRO management, with strong communication skills and a