Senior Immunogenicity Bioanalysis Leader
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Job summary
Amgen in Thousand Oaks, CA seeks a Senior Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development, validation, and CRO transfers for ADA/NAb detection in biologics. You will collaborate across drug development, regulatory teams, and CRO partners to ensure robust immunogenicity data and timely program progression.
The role emphasizes scientific leadership, data interpretation, and mentorship of staff, with broad exposure to nonclinical and clinical programs and
Qualifications
- PhD or equivalent with relevant post-doc in immunogenicity or biotherapeutics.
- Minimum years of experience aligned to degree for nonclinical/clinical programs.
- Strong publication-record and regulatory-inflected mindset
Responsibilities
- Lead immunogenicity assay development, validation, and implementation across programs.
- Oversee transfer of assays to CROs and troubleshoot transfers.
- Ensure GLP/GCP compliance and regulatory readiness.
- Interpret complex data and inform strategy for immunogenicity programs.
- Mentor laboratory staff and collaborate with cross-functional teams.
Skills
Education
Job description
Amgen in Thousand Oaks, CA seeks a Senior Principal Scientist in Immunogenicity Bioanalytical Sciences to lead assay development, validation, and CRO transfers for ADA/NAb detection in biologics. You will collaborate across drug development, regulatory teams, and CRO partners to ensure robust immunogenicity data and timely program progression.
The role emphasizes scientific leadership, data interpretation, and mentorship of staff, with broad exposure to nonclinical and clinical programs and
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