CGMP Operations & Clinical Projects Specialist

Opportunity for Health; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 62,000 - 70,000; Full time

Benefits offered by this job

Health benefits

Tuition benefits

Flexible hours

Retirement plans

Job summary

The cGMP Operations and Clinical Specialist at the University of Pennsylvania's Perelman School of Medicine will provide operational, administrative, and project support to the CVPF and HIC. The role coordinates schedules, billing, data management, documentation, and cross‑functional communication in a regulated GMP setting.

The position requires a Bachelor of Science in Biological Sciences with 3–5 years GMP experience, strong organizational and communication skills, and the ability to

Qualifications

• Bachelor of Science in Biological Sciences with coursework or experience in administration/operations.
• 2+ years data analysis in GMP/regulated environments.
• Familiarity with 21 CFR Part 11 and clinical manufacturing terminology.

Responsibilities

• Lead day-to-day cGMP manufacturing schedule updates and manage templates and tasks.
• Recruit, consent, and coordinate donor activities; ensure IRB/OCR communications are up to date.
• Provide grant and admin support, coordinate reporting deadlines and meeting materials.
• Maintain Excel-based trackers for CVPF and HIC; liaise with investigators and departments.

Skills

Data analysis

Communication

Multitasking

Microsoft Office

Education

Bachelor of Science in Biological Sciences

Tools

Excel

PowerPoint

Word

Job description

The cGMP Operations and Clinical Specialist at the University of Pennsylvania's Perelman School of Medicine will provide operational, administrative, and project support to the CVPF and HIC. The role coordinates schedules, billing, data management, documentation, and cross‑functional communication in a regulated GMP setting.

The position requires a Bachelor of Science in Biological Sciences with 3–5 years GMP experience, strong organizational and communication skills, and the ability to