Senior Scientist II - Immunoassay Bioanalysis

Role Overview

We are seeking a Senior Scientist II (Project Leader/Principal Investigator) - Immunoassay Bioanalysis (PK/ADA/PD)/Responsible Scientist to lead immunoanalytical studies, ensuring scientific robustness and regulatory compliance.

Key Responsibilities

• Act as scientific lead for PK, ADA, and PD immunoassay studies
• Oversee assay development, validation, and sample analysis
• Evaluate assay performance and investigate variability or interference issues
• Ensure assays are fit for purpose and meet regulatory requirements
• Act as primary scientific contact for clients
• Prepare, review, and approve study documentation

Technical Expertise

• Strong experience with immunoassay platforms and assay formats
• Experience in assay development, validation, and troubleshooting
• Understanding of drug interference, variability, and assay performance

Qualifications and Experience

• MSc or PhD in Immunology, Biochemistry, or related field
• 5 to 10 or more years of immunoassay bioanalysis experience
• Experience leading regulated studies in a GLP/GCP environment