Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences
Core
Design, develop, validate, and implement assays for detecting binding and neutralizing anti-drug antibodies (ADAs & NAbs) for large molecule/protein therapeutics to support GLP preclinical and regulated clinical studies.
Role type
Sr. Principal Scientist (Immunogenicity Bioanalytical Sciences)
Builds
Immunogenicity assays for Amgen's large molecule/protein therapeutics
Domain
Biotechnology / Immunogenicity / Drug Development
Required skills
Immunogenicity assay development, assay validation, regulatory guidance (GLP/GCP), statistical assay validation, data interpretation, risk assessment, CRO transfer management, mentoring
Preferred skills
Drug-tolerant assay formats, cell-based assay formats, predictive immunogenicity methods, project management, matrixed environment experience
Technologies
None explicitly listed
Responsibilities
Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation; Serve as senior subject-matter expert for ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches; Lead complex data interpretation, troubleshooting, and risk assessment; Provide scientific oversight of assay transfers to CROs; Mentor scientists and lead efforts to contribute to functional capability building
Seniority
Sr. Principal, hands-on IC with mentorship
