GMP Cell Processing Specialist

Actalent•Greensboro, NC

36d•$28 - $31•Onsite

About The Position

The Manufacturing Specialist plays a key role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment such as control rate freezers and orbital shakers, 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.

Requirements

Aseptic technique
Cleanroom sterile processing
Cell culture and cell biology
Molecular biology and DNA extraction
GMP compliance
Troubleshooting and batch record management
Microbiology expertise

Nice To Haves

AS/BS in Biotechnology, Biology, Chemistry, or related field preferred.
2-4 years of relevant experience in cell processing or biotechnology manufacturing, with 1-2 years in a cGMP-regulated environment.
Ability to exercise independent judgment and lead teams.
Strong computer skills, including Microsoft Office and ERP systems.
Advanced organizational, record-keeping, and time management skills.

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.
Conduct 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.