cGMP Clinical Lab Specialist: Cell Therapy & Immuno Testing

The Rector & Visitors of the University of Virginia; Charlottesville (VA); On-site; USD 65,000 - 85,000; Full time

Job summary

The Rector & Visitors of the University of Virginia in Charlottesville seek a Clinical Lab Specialist to support cGMP clinical manufacturing. You will produce cell therapy and antibody products, perform QC tests with QA oversight, and maintain compliance with FDA guidelines under supervision.

This role emphasizes SOP and MBR familiarity and data entry into manufacturing databases. Experience in GLP/GMP and a strong biology background are required, with extensive attention to sterility and

Qualifications

• Bachelor's Degree in biological sciences, chemistry or related discipline; Master's preferred.
• At least 1 year of experience in laboratory research; 3+ years preferred.
• Experience in Good Laboratory Practice or Good Manufacturing Practice preferred.

Responsibilities

• Specialize in cGMP methods and equipment functions for projects.
• Work with manager to ensure sterility and composition of GMP products.
• Perform QC testing of cGMP products and samples with QA oversight.
• Assist the cGMP supervisor to maintain compliance with FDA guidelines.
• Produce cell therapy, antibody and other cGMP products with SOP/MBR proficiency.
• Compile immune testing results on patient samples for analysis by cGMP manager.
• Enter clinical manufacturing data into the clinical manufacturing database.
• Review qualification documents to keep processes in a validated state.

Skills

cGMP methods

sterility

SOP adherence

MBR knowledge

QA oversight

Education

Bachelor's Degree in biological sciences

Master's degree preferred

Tools

GLP/GMP experience

cGMP equipment

Job description

The Rector & Visitors of the University of Virginia in Charlottesville seek a Clinical Lab Specialist to support cGMP clinical manufacturing. You will produce cell therapy and antibody products, perform QC tests with QA oversight, and maintain compliance with FDA guidelines under supervision.

This role emphasizes SOP and MBR familiarity and data entry into manufacturing databases. Experience in GLP/GMP and a strong biology background are required, with extensive attention to sterility and