UTS-GMP Manufacturing Technician at UNC Chapel Hill

UNC-Chapel Hill • Chapel Hill, NC

3d • Onsite

About The Position

The primary purpose of this position includes: The Advanced Cellular Therapeutics ( ACT ) Facility is a Good Manufacturing Practices ( GMP ) facility focused on expansion and manipulation of human cells for clinical phase 1 applications, specifically including applications involving chimeric antigen receptor ( CAR ) T cells. The ACT Facility also manufactures Master Cell Banks (MCBs) used in the production of clinical grade gamma retrovirus vector for use in CAR T clinical trials.

Requirements

• Perform cell culture activities within an ISO 7 clean room environment in compliance with Good Manufacturing Practices ( GMP ).
• Work aseptically in a Biological Safety Cabinet ( BSC ) to ensure product integrity and prevent contamination.
• Execute cell counting, assess cell viability, and perform related in-process testing to support the manufacturing of patient-specific cellular therapy products.
• Follow established Standard Operating Procedures (SOPs) and batch records accurately, documenting all activities in accordance with GMP requirements.
• Make routine manufacturing decisions within defined procedures to support timely and compliant production of patient products.
• Demonstrate sound judgment by recognizing when to seek guidance, escalate issues, or request support from manufacturing leadership or quality personnel when questions or deviations arise.
• Collaborate effectively with cross-functional teams to ensure safe, consistent, and high-quality manufacturing operations.

Nice To Haves

• Assist with maintaining appropriate inventory levels of materials and supplies within clean rooms and controlled release spaces, ensuring proper storage, labeling, and documentation in accordance with GMP requirements.
• Support a variety of manufacturing-related tasks as needed to meet operational demands, including preparation, cleanup, and coordination of materials and equipment.
• Lead or support validation projects for manufacturing systems, equipment, and processes, including documentation, execution, and data review activities.
• Participate in continuous improvement initiatives to enhance manufacturing efficiency, compliance, and product quality.
• Collaborate with manufacturing, quality, and facilities teams to ensure validated systems remain in a state of control.

Responsibilities

• Perform cell culture activities within an ISO 7 clean room environment in compliance with Good Manufacturing Practices ( GMP ).
• Work aseptically in a Biological Safety Cabinet ( BSC ) to ensure product integrity and prevent contamination.
• Execute cell counting, assess cell viability, and perform related in-process testing to support the manufacturing of patient-specific cellular therapy products.
• Follow established Standard Operating Procedures (SOPs) and batch records accurately, documenting all activities in accordance with GMP requirements.
• Make routine manufacturing decisions within defined procedures to support timely and compliant production of patient products.
• Demonstrate sound judgment by recognizing when to seek guidance, escalate issues, or request support from manufacturing leadership or quality personnel when questions or deviations arise.
• Collaborate effectively with cross-functional teams to ensure safe, consistent, and high-quality manufacturing operations.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 11-50 employees