Immunogenicity Bioanalysis Scientist

Amgen; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen in Thousand Oaks, CA, seeks a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement ADA and pre‑existing antibody assays in nonclinical and clinical studies within a regulated environment.

You will collaborate with project teams and external labs, review data, generate reports, and contribute to regulatory submissions. The role involves lab-based work and staying current with immunogenicity bioanalysis advances.

Qualifications

• PhD in a relevant field or a Master’s with significant immunogenicity bioanalysis experience.
• Experience in GLP/GCP regulated bioanalytical studies is preferred.
• Strong data interpretation, scientific writing, and independent problem solving.

Responsibilities

• Develop, validate, and implement ADA and pre-existing antibody assays for nonclinical and clinical studies.
• Ensure immunogenicity data and assays meet regulatory expectations and are fit for purpose.
• Collaborate with project teams and CRO/ labs to support risk assessment and regulatory submissions.
• Review scientific data, generate reports, and present results to teams.
• Support automation efforts and stay current with technology development.

Skills

Immunogenicity Bioanalytical

Bioanalytical assay execution

Regulatory guidance (GLP/GCP)

Project management

Collaboration with internal/external

Education

PhD

Master’s degree + 2 years exp

Bachelor’s degree + 4 years exp

Job description

Amgen in Thousand Oaks, CA, seeks a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement ADA and pre‑existing antibody assays in nonclinical and clinical studies within a regulated environment.

You will collaborate with project teams and external labs, review data, generate reports, and contribute to regulatory submissions. The role involves lab-based work and staying current with immunogenicity bioanalysis advances.