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Senior Scientist II (Project Leader/Principal Investigator) Immunoassay Bioanalysis (PK/ADA/PD)

Job Description - Senior Scientist II (Project Leader/Principal Investigator) Immunoassay Bioanalysis (PK/ADA/PD)

Role Overview


We are seeking a 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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