Quality Control Manager - Analytical (Cell & Gene Therapy)

Job Description:

Insight Global is seeking a Quality Control Manager – Analytical for a leading Cell and Gene Therapy client supporting late-stage clinical and commercial readiness programs. This individual will provide technical and operational leadership for advanced analytical testing platforms including flow cytometry, molecular assays, and ELISA. The role blends hands-on laboratory expertise with people leadership, regulatory compliance, and method lifecycle management. The ideal candidate thrives in a fast-paced GMP environment, brings deep CGT analytical experience, and plays a critical role in transitioning innovative therapies toward commercialization.

Qualifications:

• 9+ years of GMP QC laboratory experience in Cell & Gene Therapy or biologics manufacturing
• Advanced hands-on expertise in flow cytometry (panel design, gating strategies, multicolor analysis, CAR detection)
• Strong experience with molecular assays (qPCR/ddPCR, vector copy number, gene expression)
• Proven experience with analytical method qualification and/or validation under GMP

Day-to-Day

• Provide daily supervision and technical leadership to QC analytical staff
• Oversee and perform flow cytometry, molecular testing, and ELISA-based assays
• Ensure testing supports Phase I/II, pivotal, and commercial programs
• Review, trend, and technically evaluate analytical data for compliance and integrity
• Lead and support method qualification, validation, and transfer from Development to QC