CGMP Operations and Clinical Specialist

cGMP Operations and Clinical Specialist University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbeswho named Penn one of America's Best Large Employers in 2023.

cGMP Operations and Clinical Specialist

cGMP Operations Specialist

The cGMP Operations and Clinical Specialist will provide operational, administrative, and project support to the Clinical Cell and Vaccine Production Facility (CVPF) and Human Immunology Core (HIC). Within the CVPF, the Specialist will support day-to-day operational activities including scheduling, calendaring, internalmeeting coordination, billing, data management, software administration, documentation, and project tracking. The Specialist will coordinate activities across Operations, Manufacturing,Quality, Clinical Operations, and other functional areas while maintaining a high level of confidentiality, accuracy, and attention to detail within a highly regulated cGMP environment.

Forthe HIC, the Specialist will coordinate administrative and operational activities related to research donors, including scheduling and coordinating donor activities, processing and tracking payments, maintaining appropriate documentation and records, coordinating communications, and serving as a liaison among HIC, CVPF, CCI, and other stakeholders. The Specialist will support operational readiness and ensure activities are completed in accordance with applicable CVPF procedures, HIPAA requirements,cGMP standards, FDA regulations and guidance, FACT accreditation standards, and University and CCI requirements.

In addition, the cGMP Operations and Clinical Projects Specialist will provide administrative support and project management forgrant-related activities, serving as a central point of coordination for investigators and project personnel.

Responsibilities will include coordinating grant-related schedules and timelines, organizing and scheduling meetings, preparingagendas and meeting materials, coordinating presentations andspeakers, managing email correspondence and communications,maintaining project documentation and action-item tracking, and coordinating reporting requirements and deadlines. This position will assist with the preparation, collection, organization, and submission of grant-related reports, progress updates, supporting documentation, and other required deliverables. The role will also support communication and coordination among investigators,research staff, administrative teams, institutional offices, andother stakeholders to ensure grant activities remain organized,timelines are maintained, reporting requirements are met, and administrative tasks are completed accurately and on time

• Lead day-to-day cGMP manufacturing schedule updates in Visual Planning (VP) by applying clinical product templates, assigningprocessing rooms, and adjusting templates and culture lengths asneeded. Review upcoming cGMP production and clinical infusionschedules to ensure accuracy and efficiency. Support editing or creating clinical templates and tasks as the secondary VPadministrator. Update VP training materials, including screenshotsand PowerPoint documentation, for completeness and accuracy.
• Recruit and Consent donors for each study;
  Handle regulatory requirements, ensure study documents are up to date, and communicate with the IRB and OCR when necessary;
  Coordinate withlabs for collections;
  Complete research billing daily and ensuredonors are compensated if appropriate .
• Grant and Admin Support
  -Provide administrative and project management support for grant-related activities, including coordinating project timelines and deliverables, scheduling and coordinating investigator and project meetings, preparing agendasand meeting materials, managing email correspondence and follow-up,maintaining project documentation and action-item tracking, and coordinating reporting deadlines.
• Grant and Admin Support-Assist with preparation,collection,…