Production Regulatory Specialist (Department of Radiology)

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

Production Regulatory Specialist (Department of Radiology)

Job Profile Title

Research Specialist D

Job Description Summary

This position has several primary functions and/or responsibilities: 1) Responsible for developing and executing process validation protocol for aNDA product. 2) Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product. 3) Initiate investigation in problems associated with production. Identify and troubleshoot issues. Resolve the issues independently or within a group. 4) Develop, validate and produce other radiopharmaceuticals. 5) Author research report as part of manuscript preparation, grant application and other technical document

Job Description

Job Responsibilities

• This position has several primary functions and/or responsibilities:  1) Responsible for developing and executing process validation protocol for aNDA product. 2) Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product. 3) Initiate investigation in problems associated with production. Identify and troubleshoot issues. Resolve the issues independently or within a group. 4) Develop, validate and produce other radiopharmaceuticals. 5) Author research report as part of manuscript preparation, grant application and other technical document
• Other duties and responsibilities as assigned
• Position is contingent upon grant funding

Qualifications

• Master of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.