Cell Therapy Manufacturing Specialist I (GMP)

Biopharma Careers; Frederick (MD); On-site; USD 60,000 - 78,000; Full time

Benefits offered by this job

Discretionary annual bonus

Discretionary stock-based LTIs

Paid time off

Benefits package

Medical/dental/vision/life insurance

Job summary

Kite Pharma in Frederick, Maryland seeks a Cell Therapy Specialist I to join our state-of-the-art manufacturing team. You will perform and verify GMP manufacturing activities for commercial and clinical cell therapy products, working with cross-functional groups to ensure quality and compliance.

The role requires an associate degree (or a high school diploma with experience) and readiness to operate automated cell-processing equipment in Grade B/C cleanrooms, with training and safety in mind.

Qualifications

• Minimum an associate degree with 1 year of relevant experience, or a high school diploma with 2 years of relevant experience.
• Experience in GMP-regulated manufacturing or aseptic processing is preferred.
• Prior involvement in investigations, deviations, and change control is a plus.

Responsibilities

• Perform and verify manufacturing activities for commercial and clinical cell therapy products in accordance with batch records and SOPs.
• Troubleshoot processing and equipment issues and report findings promptly to management.
• Operate, monitor, clean, and prepare automated cell processing equipment in Grade B and C cleanrooms.
• Maintain strict adherence to cGMP, safety, gowning, and PPE requirements in classified areas.
• Complete required training to maintain proficiency and compliance.
• Identify opportunities to improve manufacturing efficiency and compliance.
• Support investigations, deviations, and change controls as needed.
• Wear respirators when handling hazardous disinfectants as required.

Skills

GMP manufacturing

Cross-functional teamwork

Equipment troubleshooting

Regulatory compliance

Education

Associate degree (1+ year experience)

High School Diploma/GED (2+ years)

Tools

Automated cell processing equipment

cGMP documentation tools

Job description

Kite Pharma in Frederick, Maryland seeks a Cell Therapy Specialist I to join our state-of-the-art manufacturing team. You will perform and verify GMP manufacturing activities for commercial and clinical cell therapy products, working with cross-functional groups to ensure quality and compliance.

The role requires an associate degree (or a high school diploma with experience) and readiness to operate automated cell-processing equipment in Grade B/C cleanrooms, with training and safety in mind.