Bioanalytical Portfolio Scientist — Immunogenicity & CRO Oversight

Amgen SA; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Retirement and savings plan

Job summary

Amgen is seeking a Bioanalytical Portfolio Scientist to act as the scientific and technical SME for outsourced immunogenicity methods, ensuring validation and optimal performance at CROs.

The role requires leadership in method development and troubleshooting, with strong communication skills and experience in working with external labs. This position emphasizes collaboration across teams and adherence to GLP/GCP principles, contributing to Amgen's mission to serve patients.

Qualifications

• Doctorate or equivalent in a relevant scientific field.
• Experience with immunogenicity assay development, validation, and troubleshooting.
• Experience coordinating with CROs and external labs.
• Strong communication and collaboration skills.
• Project and people management experience.

Responsibilities

• Provide scientific and technical oversight for immunogenicity assays transfer, validation, and execution at CROs.
• Lead transfer/validation of assays at external CROs.
• Collaborate with internal SBAEs to understand critical attributes of immunogenicity methods.
• Monitor assay performance and drive troubleshooting and improvements.
• Oversee method lifecycle management, including validation plans and reports.
• Review data, protocols, and QA documentation for GLP/GCP alignment.
• Coordinate with CROs to resolve issues within governance framework.
• Support regulatory activities.

Skills

Immunogenicity assays

ADA/NAb expertise

CRO supervision

Communication skills

Project management

Process management

Cross-functional collaboration

Quality/regulatory understanding

Troubleshooting

Education

Doctorate degree

Master’s degree + 2 yrs lab exp

Bachelor’s degree + 4 yrs lab exp

Job description

Amgen is seeking a Bioanalytical Portfolio Scientist to act as the scientific and technical SME for outsourced immunogenicity methods, ensuring validation and optimal performance at CROs.

The role requires leadership in method development and troubleshooting, with strong communication skills and experience in working with external labs. This position emphasizes collaboration across teams and adherence to GLP/GCP principles, contributing to Amgen's mission to serve patients.