Immunogenicity Bioanalytical Scientist — ADA Methods
Amgen SA
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Benefits offered by this job
Job summary
Amgen is seeking a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement sensitive assays for anti-drug antibodies and pre-existing antibodies in nonclinical and clinical studies. You will work in a lab-based role, ensuring data quality and regulatory alignment, and collaborating across teams.
You will review complex data, report findings, and support automation and technology development while advancing immunogenicity risk assessment and candidate selection early in
Qualifications
- Doctorate degree (PhD) in a relevant field or Master’s with immunogenicity bioanalytical experience or Bachelor’s with immunogenicity bioanalytical experience.
- Experience with regulated bioanalytical assays and method transfer to CROs preferred.
- Strong understanding of immunology, antibody biology, or related field and ability to work in fast-paced environment.
Responsibilities
- Develop, validate, and implement bioanalytical methods for ADA and pre-existing antibodies.
- Review and interpret scientific data, prepare reports, and present results.
- Contribute to immunogenicity risk assessment and regulatory submissions.
- Coordinate with project teams and external CROs for assay development and transfer.
- Maintain awareness of evolving regulatory expectations and provide scientific oversight.
Skills
Education
Tools
Job description
Amgen is seeking a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement sensitive assays for anti-drug antibodies and pre-existing antibodies in nonclinical and clinical studies. You will work in a lab-based role, ensuring data quality and regulatory alignment, and collaborating across teams.
You will review complex data, report findings, and support automation and technology development while advancing immunogenicity risk assessment and candidate selection early in
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