This position assists the CCI Director for Translational Sciences Operations with managing quality assurance aspects related to the initiation, conduct, oversight, and data analysis of cell and gene therapy clinical trials. These trials include first in humans through Phase II clinical development in collaboration with industry partners or otherwise. The Translational Science Quality Assurance Manager will work in a highly cross-functional environment to provide guidance, training, and review as it relates to GLP and GMP compliance in the CCI Translational Science and Correlative Studies Lab (TCSL) and the CCI Clinical Cell and Vaccine Production Facility (CVPF). This position will be tasked with evaluating quality assurance needs for those facilities in support of IND development. The Translational Science Quality Assurance Manager will assist in development and review of SOPs governing the Clinical Cell and Vaccine Production Facility and oversee fit-for purpose vendor qualification for the Center for Cellular Immunotherapies. This position will function in a key role in assuring accuracy of reports and data provided to safety boards, accreditors and federal agencies. This position will also be responsible for the development and maintenance of Drug Master Files for the Clinical Cell and Vaccine Production Facility, and all related FDA correspondence.
Internal Number: 45809
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.