About this role

Amgen is seeking a Scientist, Bioanalytical Sciences to provide technical expertise for outsourced bioanalytical methods, ensuring method validation and performance at CROs. This role involves overseeing outsourced bioanalytical phases under GLP/GCP, ensuring adherence to validated methods, data integrity, and regulatory requirements.

What we are looking for

6

Serve as technical subject matter expert for outsourced methods
Ensure adequate method validation and optimal method performance at CROs
Provide scientific and technical oversight of bioanalytical activities at CROs
Ensure adherence to validated methods, data integrity, and regulatory requirements
Lead transfer and validation of PK assays at external CROs
Review analytical data and study documentation for scientific accuracy

Skills mentioned

1

GCP