UTS - Temporary GMP Manufacturing Technician at UNC Chapel Hill

About the role

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.

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.

Qualifications

Relevant bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.

Preferred Years Experience, Skills, Training, Education

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.

Benefits

Health Insurance for Temporary Employees Enhance your career with LEAD courses Attend non-revenue generating sporting events for free. Attain Work-life balance with our Childcare discounts, Wellness & Recreation Membership, and Wellness Programs that aim to build a thriving wolfpack community.