Cell Cultures, Cleanroom, Clinical Information Systems, Clinical Trial, GMP (Good Manufacturing Practices), Housekeeping/Cleaning, ISO (International Organization for Standardization), Inventory Management, Manufacturing, Manufacturing Systems, Product Support, Standard Operating Procedures (SOP), System Validation
Location: Chapel Hill, NC
Duration: 12+ months
Schedule: 40 hours a week. 8am-5pm
Pay rate: $31.25/hr on w2
Job Description:- 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 (ClientBs) used in the production of clinical grade gamma retrovirus vector for use in CAR T clinical trials.
- Activities include cell culture work within an ISO 7 clean room environment.
- Working aseptically in a Biological Safet cabinet.
- Follow SOPs and execute cell counting, making manufacturing decisions as needed to support patient products being manufactured.
- Know when to ask questions and look for support in manufacturing when questions should arise.
- Helping to maintain inventory stock in clean rooms and release space.
- Supporting variety of other manufacturing duties as they come up as needed.
- Will be required to lead or support projects for validations of manufacturing systems.
Education:
Relevant bachelor s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.I
Integrated Resources, Inc