Job Description
We are seeking a Senior Scientist II (Project Leader/Principal Investigator) – Immunoassay Bioanalysis (PK/ADA/PD)/Responsible Scientist to lead immunoassay-based bioanalytical 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