cGMP Operations and Clinical Specialist

University of Pennsylvania; Pennsylvania; On-site; USD 62,000 - 70,000; Full time

Benefits offered by this job

Health, Life, and Flexible Spending

Tuition benefits

Retirement plans

Flexible work hours

Home ownership services

Job summary

University of Pennsylvania seeks a cGMP Operations and Clinical Specialist to support the CVPF and HIC in Philadelphia, PA. The role covers scheduling, data management, software administration, and cross‑functional coordination in a highly regulated environment.

Responsibilities include donor coordination, regulatory communications, grant administration, and reporting. Strong communication, detail orientation, and GMP familiarity are essential. Perelman School of Medicine department placement.

Qualifications

• Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience.
• College degree in the Biological Sciences with coursework or work experience in administration, business, or operations management.
• Two or more years of data analysis in quality, analytical, and operations in GMP environments.
• Familiarity with clinical manufacture and testing of cell and gene therapy products is advantageous.
• Strong communication, organization, and time-management skills.

Responsibilities

• Coordinate day-to-day administration for cGMP manufacturing and CVPF operations.
• Manage donor scheduling, consent, regulatory communications, and billing-related tasks.
• Provide grant and admin support, tracking timelines and deliverables.
• Prepare and submit progress reports and required grant documentation.
• Maintain Excel trackers for clinical trial updates and status information.
• Serve as liaison across investigators, staff, and external partners to ensure timely activity.

Skills

Communication skills

Time management

Multitasking

MS Word

MS Excel

PowerPoint

Education

Bachelor of Science

Biological Sciences degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

cGMP Operations and Clinical Specialist

University Overview

The University of Pennsylvania, the largest private employer inPhiladelphia, is a world-renowned leader in education, research,and innovation. This historic, Ivy League school consistently ranksamong the top 10 universities in the annual U.S. News & WorldReport survey. Penn has 12 highly-regarded schools that provideopportunities for undergraduate, graduate and continuing education,all influenced by Penn's distinctive interdisciplinary approach toscholarship and learning. As an employer Penn has been rankednationally on many occasions with the most recent award from Forbeswho 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 provideoperational, administrative, and project support to the ClinicalCell and Vaccine Production Facility (CVPF) and Human ImmunologyCore (HIC). Within the CVPF, the Specialist will support day-to-dayoperational activities including scheduling, calendaring, internalmeeting coordination, billing, data management, softwareadministration, documentation, and project tracking. The Specialistwill coordinate activities across Operations, Manufacturing,Quality, Clinical Operations, and other functional areas whilemaintaining a high level of confidentiality, accuracy, andattention to detail within a highly regulated cGMP environment. Forthe HIC, the Specialist will coordinate administrative andoperational activities related to research donors, includingscheduling and coordinating donor activities, processing andtracking payments, maintaining appropriate documentation andrecords, coordinating communications, and serving as a liaisonamong HIC, CVPF, CCI, and other stakeholders. The Specialist willsupport operational readiness and ensure activities are completedin accordance with applicable CVPF procedures, HIPAA requirements,cGMP standards, FDA regulations and guidance, FACT accreditationstandards, and University and CCI requirements.

In addition, the cGMP Operations and Clinical Projects Specialistwill provide administrative support and project management forgrant-related activities, serving as a central point ofcoordination for investigators and project personnel.Responsibilities will include coordinating grant-related schedulesand timelines, organizing and scheduling meetings, preparingagendas and meeting materials, coordinating presentations andspeakers, managing email correspondence and communications,maintaining project documentation and action-item tracking, andcoordinating reporting requirements and deadlines. This positionwill assist with the preparation, collection, organization, andsubmission of grant-related reports, progress updates, supportingdocumentation, and other required deliverables. The role will alsosupport 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, andadministrative tasks are completed accurately and on time

Job Responsibilities

• Lead day-to-day cGMP manufacturing schedule updates in VisualPlanning (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 orcreating 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 regulatoryrequirements, ensure study documents are up to date, andcommunicate 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 andproject management support for grant-related activities, includingcoordinating project timelines and deliverables, scheduling andcoordinating investigator and project meetings, preparing agendasand meeting materials, managing email correspondence and follow-up,maintaining project documentation and action-item tracking, andcoordinating reporting deadlines.
• Grant and Admin Support-Assist with preparation,collection, organization, and submission of progress reports,grant-related documentation, and other required deliverables. Serveas a central administrative liaison among investigators, researchpersonnel, administrative offices, and other stakeholders to ensuregrant activities, communications, and reporting requirements arecompleted accurately and on time.
• Data tracking for CVPF and HIC:Ensure up to datemaintenance of multiple Excel based dynamic trackers related toclinical trial updates including clinical trial information andstatus, patient infusion and survival status, manufacturingfailures and un-infused patients.
• Secondary liaison for alignment with both internal andexternal 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 atimely manner. Forward eligibility and consent confirmations toappropriate team members. Externally: Ensure alignment withexternal teams regarding schedule updates and final productinformation. Send out weekly clinical sample notifications to theTranslational and Correlative Studies Laboratory (TCSL) and alertthem in real time of any schedule changes throughout the week.Backup for handling resolutions for last-minute schedule changesand other major scheduling conflicts.
• Secondary support for EST and Billing-Support the cGMPOperations and Logistics Manager by providing edits and updates toproduct and patient fields in the Electronic Sample Tracker(EST).Backup for training users and troubleshooting issues. Supportthe cGMP Operations Director in billing: Review monthly invoicesand report on discrepancies and deviations. Serve as backup forbilling for CVPF services. May provide support in CVPF costanalysis activities.
• Other duties and responsibilities as assigned.

Qualifications

• Bachelor of Science and 3 to 5 years of experience orequivalent combination of education and experience is required.College degree in the Biological Sciences in combination withcoursework or work experience in administration, business, oroperations management preferred. Two or more years of data analysisin quality, analytical, and operations in a Good ManufacturingPractice (GMP) guided environment preferred. Working knowledge ofthe requirements for the clinical manufacture and testing of celland gene therapy products is desired. Familiarity with medicalterminology, knowledge of 21CFR Part 11, and work or internshipexperience in a research laboratory setting are also advantageous.Demonstrated ability to interact professionally with individuals ofvarying levels of education, experience, and job duties and tothrive in a collaborative research environment is required.Effective verbal and written communication skills are required toserve as a liaison across multifunctional groups. A detailedoriented work ethic with strong organization and excellent timemanagement skills are vital to excel in this position. The abilityto multitask is critical. Superior computer skills with MicrosoftWord, Excel, and PowerPoint are essential, as is a willingness andaptitude 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 therequirements of the position, and in alignment with salary rangesbased on external market data for the job's level. Internalorganization 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state or local law.

Special Requirements

Background checks may be required after a conditional job offer ismade. Consideration of the background check will be tailored to therequirements of the job.

University Benefits

• Health, Life, and Flexible Spending Accounts: Pennoffers comprehensive medical, prescription, behavioral health,dental, vision, and life insurance benefits to protect you and yourfamily's health and welfare. You can also use flexible spendingaccounts to pay for eligible health care and dependent careexpenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuitionbenefits. You, your spouse, and your dependent children can gettuition assistance here at Penn. Your dependent children are alsoeligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans tohelp you save for your future. Penn's Basic, Matching, andSupplemental retirement plans allow you to save for retirement on apre-tax or Roth basis. Choose from a wide variety of investmentoptions through TIAA and Vanguard.
• Time Away from Work: Penn provides you with asubstantial amount of time away from work during the course of theyear. This allows you to relax, take vacations, attend to personalaffairs, recover from illness or injury, spend time withfamily-whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with GenworthFinancial, Penn offers faculty and staff (and your eligible familymembers) long-term care insurance to help you cover some of thecosts of long-term care services received at home, in the communityor in a nursing facility. If you apply when you're newly hired, youwon't have to provide proof of good health or be subject tounderwriting requirements. Eligible family members must alwaysprovide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed tosupporting our faculty and staff as they balance the competingdemands of work and personal life. That's why we offer a widevariety of programs and resources to help you care for your health,your family, and your work-life balance.
• Professional and Personal Development: Penn provides anarray of resources to help you advance yourself personally andprofessionally.
• University Resources: As a member of the Penn community,you have access to a wide range of University resources as well ascultural and recreational activities. Take advantage of theUniversity's libraries and athletic facilities, or visit ourarboretum and art galleries. There's always something going on atPenn, whether it's a new exhibit at the Penn Museum, the latestmusic or theater presentation at the Annenberg Center, or the PennRelays at Franklin Field to name just a few examples. As a memberof the Penn community, you're right in the middle of theexcitement-and you and your family can enjoy many of theseactivities for free.
• Discounts and Special Services: From arts andentertainment to transportation and mortgages, you'll find greatdeals for University faculty and staff. Not only do Penn arts andcultural centers and museums offer free and discounted admissionand memberships to faculty and staff. You can also enjoysubstantial savings on other goods and services such as new carsfrom Ford and General Motors, cellular phone service plans, movietickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offercreative approaches for completing work while promoting balancebetween work and personal commitments. These approaches involve useof non-traditional work hours, locations, and/or jobstructures.
• Penn Home Ownership Services: Penn offers a forgivableloan for eligible employees interested in buying a home orcurrently residing in West Philadelphia, which can be used forclosing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligibleemployees on qualified expenses in connection with the legaladoption of an eligible child, such as travel or court fees, for upto two adoptions in your household.

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

Equal Employment 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), citizenshipstatus, age, disability, veteran status or any class protectedunder applicable federal, state or local law.