Senior Immunogenicity Bioanalytical Scientist Lead

Amgen SA; Thousand Oaks (CA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development and validation for ADA/NAb detection across nonclinical and clinical programs. This role collaborates with cross-functional teams and CROs, contributing to regulatory submissions and strategic immunogenicity plans.

The candidate will oversee assay transfers, apply GLP/GCP standards, and mentor junior staff, driving innovation in immunogenicity methods for large molecule therapeutics.

Qualifications

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field (post-doc where applicable) with 3 years of industry experience.
• OR Master’s degree with 6 years of industry experience.
• OR Bachelor’s degree with 8 years of industry experience.
• Experience developing immunogenicity assays per current global regulatory guidelines.
• GLP/GCP experience and CRO assay transfers.

Responsibilities

• Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation across programs.
• Serve as senior SME for ADA/NAb, cell-based and predictive immunogenicity approaches.
• Apply regulatory guidance, GLP/GCP expectations, and statistical validation principles to guide decisions.
• Lead data interpretation, troubleshooting and risk assessment for immunogenicity strategies.
• Oversee assay transfers to CROs and ensure quality, compliance, and timelines.

Skills

Immunogenicity assay development

Regulatory guidance

GLP/GCP knowledge

Data interpretation

Mentoring

Cross-functional collaboration

Project management

Education

PhD in Biochemistry/Molecular Biology/Immunology

MS in related field

BS in related field

Tools

Statistical methods

Job description

Amgen is seeking a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development and validation for ADA/NAb detection across nonclinical and clinical programs. This role collaborates with cross-functional teams and CROs, contributing to regulatory submissions and strategic immunogenicity plans.

The candidate will oversee assay transfers, apply GLP/GCP standards, and mentor junior staff, driving innovation in immunogenicity methods for large molecule therapeutics.