Immunogenicity Bioanalytical Scientist

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

Job summary

Amgen Inc. is seeking a Scientist in Immunogenicity Bioanalytical on-site in Thousand Oaks, CA. You will develop, validate, and implement ADA and pre-existing antibody assays to support nonclinical and clinical studies, ensuring data quality and regulatory alignment.

You will collaborate with project teams, CROs, and other functions, while advancing immunogenicity risk assessments and contributing to regulatory submissions and study reports.

Qualifications

• Doctorate or master's with immunogenicity bioanalytical experience required.
• Experience in GLP/GCP and regulated bioanalysis preferred.
• Ability to work across multiple projects and teams.

Responsibilities

• Develop, validate, and implement ADA and pre-existing antibody assays.
• Design validation studies in line with regulatory guidance and internal standards.
• Analyze samples under GLP/GCP; generate study reports.
• Mitigate assay challenges: high drug conc., interference, matrix effects.
• Collaborate with internal teams and external CROs; oversee bioanalytical work.

Skills

Immunogenicity Bioanalysis

Regulatory knowledge

Cross-functional collaboration

Education

PhD

Master's + 2 years immunogenicity experience

Bachelor's + 4 years immunogenicity experience

Job description

Amgen Inc. is seeking a Scientist in Immunogenicity Bioanalytical on-site in Thousand Oaks, CA. You will develop, validate, and implement ADA and pre-existing antibody assays to support nonclinical and clinical studies, ensuring data quality and regulatory alignment.

You will collaborate with project teams, CROs, and other functions, while advancing immunogenicity risk assessments and contributing to regulatory submissions and study reports.