Manufacturing Specialist II - Cell Therapy

Manufacturing Specialist III - Cell Processing

Location: Winston Salem NC

Contract Role
, 12 month long with potential to convert

Hourly Pay Rates
: $32-$35/ hour

Schedule
:
Monday-Friday 8am-5pm, with occasional overtime and weekend work required

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

• Lead and oversee cell processing activities, ensuring compliance with industry standards and best practices.

• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members.

• Set up, operate, and troubleshoot production equipment, ensuring optimal performance and preventive maintenance.

• Perform final freezing and storage of cell therapy products, ensuring adherence to procedures and maintaining quality standards.

• Revise, update, and ensure adherence to SOPs, batch records, and related forms, maintaining compliance with regulatory guidelines.

• Lead routine cycle counts and ensure accurate inventory tracking and control.

• Execute transactions within an ERP system, including material requisitions and production tracking.

• Ensure accuracy of documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).

• Lead investigations into deviations and Corrective and Preventive Action (CAPA) efforts, compiling data and information as needed.

• Provide mentorship and training to junior team members in cell processing techniques, procedures, and regulatory compliance.

• 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 controlled environment, ensuring compliance with sterile techniques and regulatory standards.

• Lead and perform cell processing activities in compliance with cGMP guidelines and internal manufacturing protocols.
• Interpret and implement Standard Operating Procedures (SOPs) and provide guidance and training to junior staff.
• Operate and maintain manufacturing equipment, including control rate freezers and orbital shakers.
• Execute final product freezing and storage in liquid nitrogen (LN2) systems while ensuring adherence to quality and safety standards.
• Review and revise GMP documentation such as SOPs, batch records, and forms to ensure compliance and accuracy.
• Oversee inventory control tasks including routine cycle counts and ERP system transactions (e.g., requisitions, production entries).
• Ensure thorough and accurate documentation of all activities in compliance with Good Documentation Practices (GDP).
• Lead or support investigations related to deviations and corrective/preventive actions (CAPAs).
• Provide mentorship, training, and technical support to less experienced personnel in the lab or cleanroom.
• Contribute to continuous improvement initiatives, including incident investigations and procedural enhancements.
• Perform aseptic processes in a cleanroom environment following sterile technique and regulatory standards.
• Assist with incoming material qualification testing and lot release evaluations.
• Support process development, validation activities, and data collection for process optimization and regulatory documentation.
• Maintain adherence to all safety protocols and promote a culture of workplace safety.

• Associate’s or Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field preferred. Significant relevant experience may be considered in lieu of formal education.
• 4–6 years of hands‑on experience in a biotechnology or cell therapy manufacturing setting, including at least 2–3 years in a…