Senior Immunogenicity Bioanalytical Scientist

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 166,000 - 224,000; Full time

Job summary

Amgen Inc. invites applications for a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences. You will lead immunogenicity assay development, validation, and transfer, collaborating with cross-functional teams and CRO partners to ensure regulatory compliance and robust data generation.

The role requires a PhD with extensive experience in ADA/NAb assay strategies, GLP/GCP, and regulatory interactions, along with strong leadership and communication skills for matrixed project work.

Qualifications

• PhD in Biochemistry, Molecular Biology, Cell Biology, Immunology or related field with relevant post-doc experience
• Strong experience in development, validation, and oversight of immunogenicity assays
• Familiarity with GLP/GCP and regulatory guidelines in immunogenicity

Responsibilities

• Provide scientific leadership for immunogenicity assay development and validation.
• Oversee assay transfers to CROs and ensure quality and timelines.
• Interpret complex data and troubleshoot to support regulatory submissions.
• Mentor scientists and contribute to capability-building in the team.

Skills

Immunogenicity assays

Regulatory guidance

Data interpretation

Team mentoring

Education

PhD in Biochemistry/Molecular Biology/Immunology

Tools

CRO transfer

Job description

Amgen Inc. invites applications for a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences. You will lead immunogenicity assay development, validation, and transfer, collaborating with cross-functional teams and CRO partners to ensure regulatory compliance and robust data generation.

The role requires a PhD with extensive experience in ADA/NAb assay strategies, GLP/GCP, and regulatory interactions, along with strong leadership and communication skills for matrixed project work.