Senior Scientist II - Immunoassay Bioanalysis

Synexa Life Sciences; Macclesfield; On-site; GBP 50,000 - 70,000; Full time

Job summary

Synexa Life Sciences (Pty) Ltd. is looking for a Senior Scientist II (Project Leader/Principal Investigator) to lead immunoassay bioanalysis studies in Macclesfield, UK. The ideal candidate will have a MSc or PhD in Immunology or Biochemistry, along with 5-10 years of experience in immunoassay bioanalysis. Responsibilities include overseeing assay development and ensuring regulatory compliance, making this a vital role in maintaining the scientific rigor of studies.

Qualifications

• 5 to 10 or more years of immunoassay bioanalysis experience.
• Experience leading regulated studies in a GLP/GCP environment.

Responsibilities

• Act as scientific lead for PK, ADA, and PD immunoassay studies.
• Oversee assay development, validation, and sample analysis.
• Ensure assays meet regulatory requirements.

Skills

Immunoassay expertise

Regulatory compliance

Assay development

Client communication

Education

MSc or PhD in Immunology, Biochemistry, or related field

Job description

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