Incumbent supports these goals by advancing translational research to clinical cell therapies through their work within the Good Manufacturing Practice (GMP) Facility. The incumbent must have excellent tissue culture skills (human cell line and stem cell culture preferred) in order to be trained in GMP grade culture of continuous human cell lines, multipotent stem cells such as mesenchymal stromal cells (MSC) and pluripotent stem cells such as human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs). Some cell lines will be used as producer cells for gene therapy vector manufacturing, such as lentiviral, retroviral and adeno-associated viral (AAV) vector. The incumbent will be manufacturing and purifying such vectors under GMP conditions.
The incumbent must be willing to work variable shifts, rotating weekends with other staff. and take call as needed on nights, weekends and holidays to ensure the Good Manufacturing Practice Facility is compliant with Federal law (21 CFR 210 and 211 ), and to work overtime within Policy and Procedure. The incumbent needs to be able to adjust to a flexible work schedule as work in the GMP facility can vary greatly and to be able to work in a full body suit and with face mask and gloves for hours in a controlled environment, such as a clean room (GMP) facility. They need to be able to work under constant supervision and in a strictly regulated environment under Standard Operating Procedures (SOPs). The incumbent must adhere to no smoking, dress code, tardiness, telephone and safety policies and protocols and work independently occasionally as the only employee (e.g.: equipment and facility monitoring on weekends holidays, etc.). All work is performed in a sterile tissue culture work environment.