Philadelphia, Philadelphia County
Mar 19, 2014

Duties: Support phase I/II clinical trials in leukemia and other cancers in the Good Manufacturing Practice (GMP) laboratories of the Clinical Cell and Vaccine Production Facility (CVPF). Primary responsibilities include clinical scale cell processing including isolation, culture and formulation, tissue culture using sterile technique and universal precautions, and assays with T cells, and dendritic cells from study subjects in support of early phase cell and gene therapy clinical trials at the University of Pennsylvania and collaborating institutions. Prepare and qualify clinical reagents and perform small scale cultures for incoming GMP reagents that are critical for clinical culture growth. Perform equipment, reagent and supply validation for new and improved methods of cell processing. Additional responsibilities include conducting quality control assays according to Good Laboratory Practices as required by the FDA for the release of the final cell product for infusion into patients. Assays include flow cytometry, endotoxin by ELISA and gel clot, and mycoplasma detection. Work with senior staff to develop new QC assays as needed. Duties include recommend, implement and maintain improvements in cell processing, including isolation, growth, harvest and cryopreservation. These improvements may include 1) the generation of master cell and working cell banks of artificial antigen presenting cells, 2) implementing equipment, reagent and supply validation for new and improved methods of stem cell processing, 3) tissue culture, 4) gene transduction methods and 5) cell characterization studies

Qualifications: Bachelor's degree in Biology or related science and a minimum of 3 to 5 years of experience in tissue culture or immunology or equivalent combination of education and experience is required. Master's degree is a plus. Experience with tissue culture and stringent aseptic technique is required. Experience with flow cytometry or ELISA strongly preferred. Excellent verbal and written communication skills required. Sound knowledge of Good Manufacturing Practices (GMPs) required. Excellent organizational record keeping skills are necessary. Position contingent upon funding. Ability to work weekends is required.

Reference Number: 40-17121

Salary Grade: 026

Employment Type: Exempt

Org: PA-Pathology Bioresource

Special Requirements: Background Check Required

Job Family: I-Technical/Professional Research