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Bioanalytical Portfolio Scientist at Amgen - ApplyBlast

Bioanalytical Portfolio Scientist

Amgen

1 month ago

3.6 on Glassdoor

Remote

Full Time

Medior

2 applicants

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About this role

The Bioanalytical Portfolio Scientist serves as a technical subject matter expert for outsourced bioanalytical methods, ensuring method validation and optimal performance at contract research organizations (CROs). This role provides scientific oversight of immunogenicity bioanalytical activities, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, while ensuring adherence to GLP/GCP principles and regulatory expectations. The position involves collaborating with internal experts and CROs to manage assay transfers, validate methods, and support continuous improvement efforts.

Responsibilities

Provide scientific oversight for outsourced immunogenicity bioanalytical activities
Lead transfer and validation of ADA and NAb assays at external CROs
Review analytical data and documentation for regulatory compliance and accuracy

Skills

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.