Senior QC Scientist, Cell & Gene Therapy Lab

University of Pittsburgh; Pittsburgh (Allegheny County); On-site; USD 90,000 - 120,000; Full time

Job summary

The University of Pittsburgh's IMCPL Laboratory seeks a Senior QC Specialist to develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products. This on-campus role requires a strong molecular biology background and hands-on assay work in a regulated environment.

The position involves PCR/qPCR and DNA/RNA analyses, troubleshooting and documentation, training of staff, and collaboration with QA, Manufacturing, and product development to ensure product safety,

Qualifications

• Strong foundation in molecular biology and hands-on experience with analytical and cell-based methods used to assess safety, identity, purity, impurities, potency, and biological activity.
• Experience with analytical development, troubleshooting, documentation, investigation, training, and quality-system responsibilities.
• Ability to develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products.

Responsibilities

• Develop, optimize, qualify, validate, execute, and maintain analytical procedures for cell and gene therapy products.
• Perform molecular biology assays including PCR, qPCR, DNA- and RNA-based analyses and related procedures.
• Collaborate with Quality Control, Quality Assurance, Manufacturing, and product development teams to support regulatory activities and lifecycle management.

Skills

Molecular biology

Analytical methods

Cell-based assays

Troubleshooting

Documentation

Training

Quality systems

Education

Bachelor's Degree

Tools

PCR

qPCR

Job description

The University of Pittsburgh's IMCPL Laboratory seeks a Senior QC Specialist to develop, qualify, validate, and maintain analytical procedures for cell and gene therapy products. This on-campus role requires a strong molecular biology background and hands-on assay work in a regulated environment.

The position involves PCR/qPCR and DNA/RNA analyses, troubleshooting and documentation, training of staff, and collaboration with QA, Manufacturing, and product development to ensure product safety,