Senior Immunogenicity Scientist – ADA/NAb Expert

Biopharma Careers; Thousand Oaks (CA); On-site; USD 165,000 - 224,000; Full time

Job summary

Amgen is seeking a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development, validation, and transfer for ADA/NAb analyses across nonclinical and clinical programs in a collaborative, regulatory-focused environment.

The role demands deep immunogenicity expertise, strong communication, project management, and mentoring of laboratory staff while partnering with CROs and cross-functional teams to ensure compliance with GLP/GCP guidelines and timely study delivery.

Qualifications

• PhD with industry experience in immunogenicity assay development and validation.
• Master’s or Bachelor’s with substantial industry experience acceptable.
• Experience with GLP/GCP guidelines and regulatory expectations.

Responsibilities

• Provide scientific leadership for immunogenicity assay development, validation, transfer, and implementation.
• Serve as a senior SME for ADA, NAb, drug-tolerant, cell-based, and predictive approaches.
• Apply regulatory guidance and statistical validation principles to guide decisions.
• Lead data interpretation, troubleshooting, and risk assessment for program support.
• Oversee assay transfers to CROs and ensure quality, compliance, and timelines.
• Mentor scientists and contribute to capability building and best-practice development.

Skills

Immunogenicity assay development

Regulatory guidance

Mentoring / leadership

Education

Doctorate in Biochemistry / Molecular Biology / Immunology

Master’s degree in a related field

Bachelor’s degree in a related field

Tools

CRO transfers

Job description

Amgen is seeking a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development, validation, and transfer for ADA/NAb analyses across nonclinical and clinical programs in a collaborative, regulatory-focused environment.

The role demands deep immunogenicity expertise, strong communication, project management, and mentoring of laboratory staff while partnering with CROs and cross-functional teams to ensure compliance with GLP/GCP guidelines and timely study delivery.