💼 About This Role

You'll lead a cell therapy manufacturing team in a cGMP facility, overseeing production of autologous and allogeneic products. You'll drive cross-functional collaboration to ensure safe, compliant, and timely delivery to patients.

🎯 What You'll Do

• Lead and develop a manufacturing team for cell therapy production.
• Oversee manufacturing processes including engineering runs and PPQ.
• Ensure compliance with cGMP and aseptic techniques on the floor.
• Initiate and close deviations, CAPAs, and change controls.

📋 Requirements

• Bachelor's degree in science or engineering.
• 6+ years cGMP operations experience in biotech/pharma.
• 3+ years leadership experience in a GMP environment.
• Cell/Gene Therapy experience required.

✨ Nice to Have

• CDMO experience preferred.
• Lean Six Sigma certification preferred.
• Experience with FDA interactions and regulatory audits.