Immunogenicity Bioanalytical Portfolio Scientist

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Bioanalytical Portfolio Scientist to act as the technical SME for outsourced immunogenicity assays, ensuring validation and optimal performance at CROs.

The ideal candidate has strong experience with ADA and NAb assays and a proven track record in method development and troubleshooting. The role requires collaboration with internal experts and adherence to GLP/GCP standards.

Qualifications

• Doctorate or equivalent with regulated lab experience.
• Experience with immunogenicity assays (ADA/NAb) preferred.
• Experience working with CROs and regulatory expectations.

Responsibilities

• Provide scientific and technical oversight for transfer, validation, and execution of immunogenicity assays at CROs.
• Lead transfer and validation of assays at external CROs.
• Monitor assay performance and drive continuous improvement.

Skills

Immunoassay expertise

CRO collaboration

Project management

Communication skills

Regulatory knowledge

Education

Doctorate degree

Masters degree with 2 years regulated lab experience

Bachelor's degree with 4 years regulated lab experience

Job description

Amgen seeks a Bioanalytical Portfolio Scientist to act as the technical SME for outsourced immunogenicity assays, ensuring validation and optimal performance at CROs.

The ideal candidate has strong experience with ADA and NAb assays and a proven track record in method development and troubleshooting. The role requires collaboration with internal experts and adherence to GLP/GCP standards.