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

Confidential

Macclesfield, Cheshire permanent

Posted: April 2, 2026

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Quick Summary

We are seeking a Responsible Scientist to lead immunoassay-based bioanalytical studies, ensuring scientific robustness and regulatory compliance.

Required Skills

Assay Development Assay Validation Error Troubleshooting Regulatory Compliance Drug Target Identification Assay Robustness Study Documentation Client Communication Immunoassay Platforms

Job Description

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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