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
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