Immunogenicity Bioanalytical Scientist – ADA Antibody Profile

BioSpace

Thousand Oaks (CA)

On-site

USD 130,000 - 170,000

Full time

3 days ago

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Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Annual bonus program

Stock-based incentives

Flexible work options

Job summary

Amgen in Thousand Oaks is seeking a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement ADA and pre-existing antibody assays in nonclinical and clinical studies, ensuring immunogenicity data are robust and regulatory-ready.

You will collaborate across project teams and external labs, review data, generate reports, support automation, and contribute to risk assessment and candidate selection early in development.

Qualifications

PhD or equivalent in biology, pharmacology, or related field.
Experience in immunogenicity bioanalysis is required or strongly preferred.
Knowledge of regulatory expectations in GLP/GCP.

Responsibilities

Develop and validate ADA and pre-existing antibody assays.
Validate ADA methods per regulatory guidance.
Conduct sample analysis under GLP and GCP.
Prepare and review bioanalytical reports and study reports.
Oversee external CRO bioanalytical work.
Support regulatory submissions and immunogenicity risk assessment.

Skills

Immunogenicity Bioanalysis

GLP/GCP knowledge

Bioanalytical assay execution

Project management

Cross-functional collaboration

Education

PhD in a related field

Master's degree with Immunogenicity Bioanalytical experience

Bachelor's degree with Immunogenicity Bioanalytical experience

Job description

You will collaborate across project teams and external labs, review data, generate reports, support automation, and contribute to risk assessment and candidate selection early in development.

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