Principal Scientist, Project Toxicologist

Scorpion Therapeutics; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Amgen is seeking a Senior Principal Scientist to lead immunogenicity bioanalytical assay development for large molecule therapeutics, supporting GLP preclinical and regulated clinical studies.

You will design, validate, transfer, and implement ADA/NAb assays; provide scientific leadership; oversee assay transfer to CROs and contribute to regulatory documentation.

Qualifications

• PhD in Biochemistry, Immunology, or related field. 3+ years industry experience preferred.
• Strong knowledge of GLP/GCP, global regulatory guidelines, and statistical validation.
• Experience with cell-based and drug-tolerant immunogenicity assays.
• Supervisory skills preferred.

Responsibilities

• Design, develop, validate, transfer, and implement ADA and NAb assays.
• Provide scientific leadership in assay strategy, troubleshooting, and data interpretation.
• Oversee assay transfer to CROs; ensure regulatory compliance and contribute to regulatory documentation.

Skills

GLP/GCP knowledge

Immunogenicity assays

Regulatory guidelines

Supervisory skills

Data interpretation

Education

PhD in Biochemistry/Immunology

Job description

Senior Principal Scientist

leading immunogenicity bioanalytical assay development for large molecule therapeutics at Amgen, supporting GLP preclinical and regulated clinical studies.

Responsibilities

• design, develop, validate, transfer, and implement assays for anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)
• provide scientific leadership in assay strategy, troubleshooting, and data interpretation
• oversee assay transfer to CROs, ensure compliance with regulatory standards, and contribute to regulatory documentation

Requirements

• PhD in Biochemistry, Immunology, or related field with 3+ years industry experience, or equivalent with relevant expertise in immunogenicity assays
• strong knowledge of GLP/GCP, global regulatory guidelines, and statistical validation
• experience with cell-based and drug-tolerant immunogenicity assays
• supervisory skills preferred

HighValue

• expertise in ADA/NAb assay development, validation, and transfer per global standards
• familiarity with predictive immunogenicity methods
• experience in a matrixed environment supporting preclinical and clinical stages
• ability to lead cross-functional teams and mentor staff

WorkSetup

not specified, but implies collaboration across research, development, and CROs.