cGMP Operations and Clinical Specialist

University of Pennsylvania; Philadelphia (Philadelphia County); On-site; USD 62,000 - 70,000; Full time

Job summary

The University of Pennsylvania in Philadelphia seeks a cGMP Operations Specialist to provide operational, administrative, and project support to the CVPF and HIC, handling scheduling, calendaring, billing, data management, and documentation in a highly regulated cGMP environment.

You will coordinate with Operations, Manufacturing, Quality, and Clinical Operations while maintaining confidentiality and accuracy, ensure regulatory compliance with HIPAA, FDA guidance, FACT accreditation, and

Qualifications

• BS degree and 3–5 years of related GMP/operations experience.
• Experience with data analysis in a regulated environment is preferred.
• Strong communication and cross-functional collaboration skills.
• Detail-oriented with excellent organization and time management.

Responsibilities

• Coordinate day-to-day cGMP manufacturing scheduling and VP project templates.
• Coordinate donor activities, regulatory requirements, and IRB communications.
• Provide grant and administrative support, including meeting logistics and reporting.
• Maintain Excel-based trackers for clinical trial status and manufacturing data.

Skills

Data analysis

Scheduling

Communication

Multitasking

Time management

Education

Bachelor of Science

Tools

Microsoft Word

Excel

PowerPoint

Job description

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.

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.

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 to thrive in a collaborative research environment is required. Effective verbal and written communication skills are required to serve as a liaison across multifunctional groups. A detailed oriented work ethic with strong organization and excellent time management skills are vital to excel in this position. The ability to multitask is critical. Superior computer skills with Microsoft Word, Excel, and PowerPoint are essential, as is a willingness and aptitude for learning new software systems.

This position is contingent upon grant funding.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$62,000.00 - $70,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (