Cell Therapy QC Specialist (cGMP)

University of Southern California; Glendale (CA); On-site; USD 87,576 - 92,000; Full time

Job summary

The University of Southern California's Keck School of Medicine, Department of Medicine, seeks a QC Specialist to oversee quality control testing for cell and gene therapy products in a cGMP facility.

You will design and implement QC testing, review batch records, and support technology transfer from pre-clinical to cGMP. Candidates should have a biotechnology degree, leadership experience, and familiarity with FDA regulations and clinical trials.

Qualifications

• Bachelor’s degree or higher in biotechnology or closely related field.
• Demonstrated knowledge of all aspects of biotechnology and cell therapy.
• Experience with FDA regulations and clinical trials.
• Extensive leadership experience.

Responsibilities

• Supports cGMP manufacturing operations with responsibility for quality control.
• Performs cGMP batch release testing to ensure quality before patient use.
• Writes and reviews qualifications, SOPs, and batch records as required.
• Operates instrumentation for cell and gene therapy manufacturing and assists in tech transfer.

Skills

Excellent written and oral comms

Leadership experience

cGMP knowledge

Education

Bachelor’s degree in biotechnology or closely related field

Master’s degree (preferred)

Job description

The University of Southern California's Keck School of Medicine, Department of Medicine, seeks a QC Specialist to oversee quality control testing for cell and gene therapy products in a cGMP facility.

You will design and implement QC testing, review batch records, and support technology transfer from pre-clinical to cGMP. Candidates should have a biotechnology degree, leadership experience, and familiarity with FDA regulations and clinical trials.