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Department: 480502 - UHR UTS/UNC Partnership

Essential Job Duties:

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.

Other Work/Responsibilities:

Other duties as needed

Required Qualifications:

+ 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.

Preferred Qualifications:

+ 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.

Required license or certification:

N/A

Position Number: 48SM26

AA/EEO Statement:

NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity.

If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or [email protected].

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.

NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.