UTS-GMP Manufacturing Technician at UNC Chapel Hill
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Job Location:
Chapel Hill, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Summary
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.
Required Qualifications Competencies And Experience
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 Competencies And Experience
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.
Work Schedule
MondayFriday 8:00 AM5:00 PM
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.
Required Qualifications Competencies And Experience
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 Competencies And Experience
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.
Work Schedule
MondayFriday 8:00 AM5:00 PM
Required Experience:
Staff IC
Key Skills
- Lean Manufacturing
- Hand Tools
- Basic Math
- Math
- Mechanical Knowledge
- Assembly Experience
- Computer Literacy
- Schematics
- cGMP
- Clamp Truck
- Programmable Logic Controllers
- Manufacturing
About Company
The University of North Carolina at Chapel Hill, the nation’s first public university, is a global higher education leader known for innovative teaching, research and public service. A member of the prestigious Association of American Universities, Carolina regularly ranks as the best ... View more
