Cell Therapy Lead: GMP/IND Lab & Process Champion

Children's National Hospital; Washington (District of Columbia); On-site; USD 78,000 - 129,000; Full time

Job summary

Children’s National Hospital seeks a Cellular Therapy Laboratory Lead to oversee development, validation, and manufacturing of novel cell therapies for clinical trials and INDs. You will coordinate quality, regulatory documentation, and project management across GMP/GTP environments.

The role requires expertise in cell-based assays, data analysis, and staff supervision, with duties spanning process development, product release, and SOP maintenance in a clinical setting.

Qualifications

• Bachelor's degree in basic science or related field required.
• Ph.D. preferred for advanced translational work.
• Minimum 4 years of cell therapy or cell transplant experience with BS/MT.
• 2 years' experience with a PhD in translational research laboratory required.
• Supervisory experience desired.

Responsibilities

• Lead quality program activities and ensure regulatory compliance.
• Coordinate project schedules, testing, and data analysis for clinical trials.
• Oversee manufacture and release of cell therapy products for clinical use.
• Maintain SOPs, document controls, and participate in audits and inspections.
• Mentor junior staff and coordinate training within the team.

Skills

Cell therapy experience

Leadership

Data analysis

Education

Bachelor's degree in basic science or related field

Ph.D. preferred

Tools

Flow cytometry

Elispot

FlowJo

Prism

Job description

Children’s National Hospital seeks a Cellular Therapy Laboratory Lead to oversee development, validation, and manufacturing of novel cell therapies for clinical trials and INDs. You will coordinate quality, regulatory documentation, and project management across GMP/GTP environments.

The role requires expertise in cell-based assays, data analysis, and staff supervision, with duties spanning process development, product release, and SOP maintenance in a clinical setting.