Bioanalytical Portfolio Scientist, CRO Oversight (Flexible)

amgen; United States; On-site; USD 109,000 - 147,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Retirement plan

Medical/dental/vision coverage

Job summary

Amgen seeks a Bioanalytical Portfolio Scientist to provide scientific oversight of outsourced immunogenicity assays, including ADA and NAb, ensuring transfer, validation, and performance at CROs in alignment with GLP/GCP standards.

The role emphasizes collaboration with internal experts, method lifecycle management, data integrity, and regulatory support to deliver high-quality bioanalytical work for oncology, inflammation, and rare diseases programs.

Qualifications

• Doctorate degree
• OR Master’s degree and 2 years of regulated scientific laboratory experience
• OR Bachelor’s degree and 4 years of regulated scientific laboratory experience
• Demonstrated expertise in Immunoassay development, validation, and troubleshooting for ADA and NAb (cell based or non-cell based) assays
• Knowledgeable on current regulatory expectations, industry best practices, and applicable scientific guidance
• Experienced in working with CROs
• Project and people management
• Process management and planning skills
• Excellent written and verbal communication skills
• Collaborates, negotiates and persuades others, both internally and externally
• Openly promotes cooperation across the organization
• Project and issue management skills
• Drives for results; delivers processes and outcomes of the highest quality
• Consistently communicates in a manner that is appropriate to the situation

Responsibilities

• Provides scientific and technical oversight for the transfer, validation, and execution of immunogenicity assays, including anti-drug antibody (ADA) and cell based or non-cell based neutralizing antibody (NAb) assays, ensuring adherence to sponsor requirements and current regulatory expectations, industry best practices, and applicable scientific guidance.
• Leads the transfer and validation of assays at external CROs
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the immunogenicity methods to ensure successful assay transfer and validation
• Monitors assay performance over time and provides input for troubleshooting and continuous improvement efforts
• Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification of reagents and reference material
• Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and current regulatory guidance
• Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure
• Provides subject matter expertise during supplier evaluation and monitoring activities
• Follows and contributes to guidance documents and SOPs
• Supports regulatory activities

Skills

Immunoassay development

Validation

Troubleshooting

CRO collaboration

Project management

Verbal communication

Written communication

Cross-functional collaboration

Education

Doctorate degree

Master's degree + 2 years in regulated lab

Bachelor's degree + 4 years in regulated lab

Job description

Amgen seeks a Bioanalytical Portfolio Scientist to provide scientific oversight of outsourced immunogenicity assays, including ADA and NAb, ensuring transfer, validation, and performance at CROs in alignment with GLP/GCP standards.

The role emphasizes collaboration with internal experts, method lifecycle management, data integrity, and regulatory support to deliver high-quality bioanalytical work for oncology, inflammation, and rare diseases programs.