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 Forbes who named Penn one of America’s Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

cGMP Operations and Clinical Specialist

Job Profile Title

cGMP Operations Specialist

Job Description Summary

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, internal meeting 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. For the 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 for grant-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, preparing agendas and meeting materials, coordinating presentations and speakers, 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, and other stakeholders to ensure grant activities remain organized, timelines are maintained, reporting requirements are met, and administrative tasks are completed accurately and on time

Job Description

Job Responsibilities

Lead day-to-day cGMP manufacturing schedule updates in Visual Planning (VP) by applying clinical product templates, assigning processing rooms, and adjusting templates and culture lengths as needed. Review upcoming cGMP production and clinical infusion schedules to ensure accuracy and efficiency. Support editing or creating clinical templates and tasks as the secondary VP administrator. Update VP training materials, including screenshots and 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 with labs for collections; Complete research billing daily and ensure donors 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 agendas and 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, organization, and submission of progress reports, grant-related documentation, and other required deliverables. Serve as a central administrative liaison among investigators, research personnel, administrative offices, and other stakeholders to ensure grant activities, communications, and reporting requirements are completed accurately and on time.

Data tracking for CVPF and HIC: Ensure up to date maintenance of multiple Excel based dynamic trackers related to clinical trial updates including clinical trial information and status, patient infusion and survival status, manufacturing failures and un-infused patients.

Secondary liaison for alignment with both internal and external groups -Internally: Prepare and send out weekly “internal events” meeting minutes for internal staff alignment. Alert internal teams of critical changes in the schedule in a timely manner. Forward eligibility and consent confirmations to appropriate team members. Externally: Ensure alignment with external teams regarding schedule updates and final product information. Send out weekly clinical sample notifications to the Translational and Correlative Studies Laboratory (TCSL) and alert them in real time of any schedule changes throughout the week. Backup for handling resolutions for last-minute schedule changes and other major scheduling conflicts.

Secondary support for EST and Billing- Support the cGMP Operations and Logistics Manager by providing edits and updates to product and patient fields in the Electronic Sample Tracker (EST). Backup for training users and troubleshooting issues. Support the cGMP Operations Director in billing: Review monthly invoices and report on discrepancies and deviations. Serve as backup for billing for CVPF services. May provide support in CVPF cost analysis activities.

Other duties and responsibilities as assigned.

Qualifications

Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required. College degree in the Biological Sciences in combination with coursework or work experience in administration, business, or operations management preferred. Two or more years of data analysis in quality, analytical, and operations in a Good Manufacturing Practice (GMP) guided environment preferred. Working knowledge of the requirements for the clinical manufacture and testing of cell and gene therapy products is desired. Familiarity with medical terminology, knowledge of 21CFR Part 11, and work or internship experience in a research laboratory setting are also advantageous. Demonstrated ability to interact professionally with individuals of varying levels of education, experience, and job duties and