Cell Therapy Manufacturing Specialist (GMP | CAR-T)

Immediate need for a talented Cell Therapy Manufacturing Specialist (GMP | CAR-T). This is a 06 months contract opportunity with long-term potential and is located in Frederick, Maryland (Onsite). Please review the job description below and contact me ASAP if you are interested.
 
Job Diva ID: 25-94404
 
Pay Range: $30 - $33 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities:

• Location: Remote (25% travel to Foster City, CA)
• Duration: Contract / Full-Time (Specify)
• Day Shift: 6:00 AM–4:30 PM (Sun–Wed or Wed–Sat)
• Swing Shift: 3:00 PM–1:30 AM (Sun–Wed or Wed–Sat)
• Complete all required New Hire Orientation Technical Manufacturing Training (first 6–8 weeks, Mon–Fri, 07:30–16:00)
• Perform and/or verify all GMP manufacturing steps according to batch records and SOPs
• Routinely operate, clean, prepare, and monitor automated cell processing, cell expansion, and filling systems within Grade B/C cleanrooms
• After training, transition into a 4/10 shift as assigned:
• Troubleshoot equipment and process issues; communicate promptly to leadership
• Author, revise, and follow GMP-compliant SOPs to support safe and efficient operations
• Support investigations, deviations, change controls, and CAPA activities
• Maintain aseptic technique, full gowning/PPE compliance, and contamination-control readiness.
• Identify opportunities to improve manufacturing efficiency, safety, and compliance.
• Wear a respirator when required during cleaning procedures involving select chemicals.

Key Requirements and Technology Experience:

• Key skills; Cell Therapy, Cell Manufacturing, cGMP, Quality Validation Experience.
• cGMP manufacturing experience in biologics, cell therapy, or pharmaceutical operations
• Aseptic technique & ability to perform sterile gowning for Grade B/C cleanrooms
• Experience operating or supporting automated cell processing, cell expansion, or filling equipment
• Strong GMP documentation discipline (batch records, SOPs, deviations, change controls)
• Ability to troubleshoot process and equipment issues and escalate appropriately
• Ability to stand for extended periods and wear full PPE/respirator when required
• Strong adherence to compliance, safety, and contamination-control standards

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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