- Clinical Trials
- Medical Terminology
- Tissue Culture
- Regulatory Reporting
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. Working knowledge of HIPAA requirements and cGMP practices is essential. 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, cellular manufacturing is preferred. 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. 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. 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. 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; Recommend, implement and maintain improvements in cell processing, including isolation, growth, harvest and cryopreservation. Additional responsibilities may apply.
Bachelor’s degree in Biology or related science required and 3 years to 5 years of experience or an equivalent combination of experience and education required. . Minimum of 18 months in tissue culture or immunology or equivalent combination of education and experience. Experience with tissue culture and stringent aseptic technique is required. Experience with flow cytometry preferred. Excellent verbal and written communication skills required. Sound knowledge of Good Manufacturing Practices (GMPs) preferred. Excellent organizational record keeping skills are necessary. Position contingent upon funding. Flexibility to work weekends is required. It is possible that this position may include a 5-day 8-hour work week including one weekend day.
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