Job description

Duties: This position will support Quality Control clinical testing activities for cell and gene therapy clinical trials to treat patients with cancer and HIV supported by the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania. This position reports to the Quality Control Team lead with primary responsibilities that include demonstrating proficiency to perform clinical release testing on cell therapy products, including but not limited to, immunophenotyping (Flow Cytometry), sterility, mycoplasma, viability, residual bead counting, and ex vivo culture assays. Use of sterile technique and universal precautions as well as capabilities to perform immunoassays with primary human cells from study subjects in support of cell and gene therapy clinical trials at the University of Pennsylvania and collaborating institutions, is required. Proven subject matter expertise and ability to lead validation projects to improve and/or optimize current processes is required. Additional responsibilities include equipment, reagent and supply validation for new and improved testing methods. Additional responsibilities may apply. Routine interaction with manufacturing technicians, quality control scientists, quality assurance personnel, and additional support staff is necessary. This position is an essential University employee and is required to report to work in times of inclement weather and University closure.

Qualifications: Bachelor's degree in Biology or related science and 3yrs to 5yrs experience or a combination of experience and education required. Master's degree preferred. A minimum of 18 months in tissue culture or immunology or equivalent required. Experience with tissue culture and stringent aseptic technique is required. Previous experience with human primary cell cultures is required. Direct experience culturing T cells and/or dendritic cells is strongly preferred. Working knowledge of HIPAA requirements, and experience with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Laboratory (Research) Practices (GCP) is desired. Experience with testing samples from large scale expansion cultures manufactured in a regulated clean room laboratory environment, according to good laboratory practices (GLP) and good tissue practices (GTP) is strongly desired. Demonstrated proficiency to perform assays in at least one specialized Quality Control functional area (ie. Flow Cytometry, microbiology, viability, ex vivo cell culture) is required. Ability to be cross-trained to perform QC assays across specialized functions is desired. Excellent verbal and written communication skills are required. Previous demonstrated experience working with clinical trials, and in particular, and clinical product release testing is preferred. Knowledge of medical terminology and intellectual capacity to use judgement and critical thinking skills to ensure that the data are accurate, logical, and consistent with institutional and regulatory reporting requirements are required. Efficient time management and ability to multi-task at a given time are essential. Excellent organizational record keeping skills are necessary. Flexibility to work weekends is required. Position is contingent upon funding.

Reference Number: 40-28081

Salary Grade: 026

Employment Type: Exempt

Org: CI-Center for Cellular Immunotherapy

Special Requirements:

Job Family: I-Technical/Professional Research




Diversity Profile: University



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Job No:
Posted: 2/28/2018
Application Due: 4/30/2018
Work Type: