cGMP Operations & Clinical Projects 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

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.