Job description

Duties: This position will support cellular manufacturing 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) and Center for Advanced Cellular Therapies (CACT) at the University of Pennsylvania. This position reports to the Manufacturing Operations Manager with primary responsibilities that include clinical scale cell processing including isolation, culture and formulation, tissue culture using sterile technique and universal precautions, and assays with primary human cells from study subjects in support of cell and gene therapy clinical trials at the University of Pennsylvania and collaborating institutions. Additional responsibilities include equipment, reagent and supply validation for new and improved methods of cell processing, as well as recommend, implement and maintain improvements in cell processing, including isolation, growth, harvest and cryopreservation. Additional responsibilities may apply. Routine interaction with additional 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.

Position is contingent on continued funding.

Qualifications: A Bachelor's Degree in Biology and 3 years to 5 years of experience or equivalent combination of education and experience is required, Master's degree strongly preferred. A minimum of 18 months in tissue culture or immunology or equivalent combination of education and experience is preferred. 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 Clinical (Research) Practices (GCP) is desired. Demonstrated experience with large scale expansion cultures and operating in a regulated clean room laboratory environment, according to good laboratory practices (GLP) and good tissue practices (GTP) is strongly preferred. Experience with flow cytometry or ELISA strongly preferred. Excellent verbal and written communication skills required. Exceptional organizational skills, strong attention to detail, and demonstrated expertise in tissue culture are required. Previous demonstrated experience working with clinical trials, and in particular, and cellular manufacturing 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 to complete activities for several different clinical trial studies at a given time are essential. Excellent organizational record keeping skills are necessary. Flexibility to work weekends is required.

Reference Number: 40-25379

Salary Grade: 026

Employment Type: Exempt

Org: PA-Pathology Bioresource

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: I-Technical/Professional Research




Diversity Profile: University



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Job No:
Posted: 4/24/2017
Application Due: 4/24/2018
Work Type: