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 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 (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.

• Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.

• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.

• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.

• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.

• Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.

• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.

• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.

• Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.

• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.

• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.

• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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