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Senior Scientist II – Immunoassay Bioanalysis
synexalifesciences
MacclesfieldOn-site2mo ago
- Employment
- Full-time
- Seniority
- Senior
About the role
Role Overview
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
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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