Principal Immunogenicity Bioanalytical Scientist

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Total Rewards Plan

Competitive benefits package

Flexible work models

Job summary

Amgen in Thousand Oaks is seeking a Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development for ADA and NAb detection. You will collaborate across drug development, research, and compliance to ensure assay suitability and regulatory readiness.

The role involves supervising lab staff, mentoring junior scientists, and coordinating with external CROs to transfer assays, validate methods, and support GLP preclinical and clinical studies.

Qualifications

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field and 2 years of experience.
• OR Masters degree with 5 years of experience in a scientific/technical role.
• OR Bachelors degree with 7 years of experience in a scientific/technical role.
• Experience developing, validating, and overseeing immunogenicity assays per global guidelines.
• Experience transferring assays to bioanalytical CROs and knowledge of GLP/GCP.

Responsibilities

• Support design, development, validation, and implementation of immunogenicity assays for ADA/NAb detection.
• Collaborate with drug development teams, CROs, and regulatory groups; contribute to regulatory filings.
• Supervise or mentor laboratory staff and manage multiple projects concurrently.

Skills

Verbal and written communication

Multi-tasking

Project management

Collaboration

Data interpretation

Education

Doctorate in Biochemistry/Molecular Biology/Cell Biology/Immunology

Masters degree

Bachelors degree

Job description

Amgen in Thousand Oaks is seeking a Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development for ADA and NAb detection. You will collaborate across drug development, research, and compliance to ensure assay suitability and regulatory readiness.

The role involves supervising lab staff, mentoring junior scientists, and coordinating with external CROs to transfer assays, validate methods, and support GLP preclinical and clinical studies.