cGMP Operations and Clinical Projects Associate

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Posted Job Title

cGMP Operations and Clinical Projects Associate

Job Profile Title

Research Coordinator Senior

Job Description Summary

The Clinical Operations Associate will support the Clinical Cell and Vaccine Production Facility (CVPF) at the University of Pennsylvania in the coordination of development, manufacture, and testing of cell and gene therapy products for novel, first-in-human early phase I/II clinical trials in HIV and cancer under Good Manufacturing Practice (GMP) guidance and Good Laboratory Practice (GLP) compliance. The cGMP Operations and Clinical Projects Associate will serve as a liaison across multiple functional groups within the CVPF, including Operations, Manufacturing, Quality Control, Quality Systems, Quality Assurance, and Facilities. The individual will report to the cGMP Operations and Logistics Manager and provide support in the areas of: scheduling, billing, website maintenance, and software systems maintenance/administration. In addition, the cGMP Operations and Clinical Projects Associate will provide support to the HIC within CCI. HIC activities will fall under the direction of the CVPF cGMP Operations Director in conjunction with Dr. James Riley.

Job Description

Job Responsibilities

Lead for cGMP Manufacturing Scheduling

• In real time, lead the day-to-day CVPF clinical production schedule updates in the Visual Planning (VP) software:
  • Apply appropriate clinical product templates and assign cGMP processing rooms.
  • Adjust applied clinical templates and cGMP culture lengths as appropriate.
• Consistently review the upcoming cGMP production and clinical infusion product schedules to ensure accuracy and efficiency.
• Provide support in editing existing and/or creating new clinical templates and tasks as the secondary administrator of Visual Planning.
• Update VP training documentation, e.g. take screenshots and update existing PowerPoint presentations for completeness a