Cell Processing Specialist III

Manufacturing Cell Processing Specialist III

The Manufacturing Specialist plays a crucial role in supporting advanced manufacturing operations, focusing on cell processing activities while ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment, performing final product freezing and storage, and driving continuous improvement. The Manufacturing Specialist is responsible for mentoring team members, leading investigations, and ensuring high levels of quality and compliance.

Responsibilities:

• Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and manufacturing standards.
• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.
• Set up, operate, and troubleshoot production equipment such as control rate freezers and orbital shakers, ensuring optimal performance and preventive maintenance.
• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards.
• Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance.
• Lead routine cycle counts and ensure accurate inventory tracking and control.
• Execute transactions within the ERP system, including material requisitions and production tracking.
• Ensure accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices.
• Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as required.
• Drive continuous process improvement, incident investigations, and deviation resolutions.
• Ensure all activities comply with safety policies, rules, and regulations, promoting a safe working environment.
• Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.

Essential Skills:

• Aseptic technique
• Cleanroom experience
• Sterile processing
• Cell culture
• Cell biology
• Molecular biology
• GMP compliance
• Troubleshooting
• Batch record management

Additional Skills & Qualifications:

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field preferred. Relevant experience may substitute for formal education.
• Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with 2-3 years of proven expertise in a cGMP-regulated environment.
• Ability to exercise independent judgment and lead teams.
• Strong computer skills, including Microsoft Office, and expertise in ERP systems.
• Advanced organizational, record-keeping, and time management skills.

Work Environment:

The role involves working in both lab and office settings, specifically in a cleanroom environment with level 10k and 100k cleanroom certifications. The position requires sterile gowning, and the ability to maintain certification for sterile gowning.

Job Type & Location:

This is a Contract to Hire position based out of Winston Salem, NC.

Pay and Benefits:

The pay range for this position is $35.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Winston Salem, NC.

Application Deadline:

This position is anticipated to close on Jan 16, 2026.