Preclinical Systems Coordinator, Gene Therapy Department
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Posted Job Title
Preclinical Systems Coordinator (Gene Therapy Dept.)
Job Profile Title
Manager Research Project A
Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Continuation of all GTP positions is contingent upon funding.
The Preclinical Systems Coordinator is a team member of the Program for Comparative Medicine (PCM) within the Gene Therapy Program (GTP) at the University of Pennsylvania and reports directly to the Core Program Manager under the Supervision of the Senior Director, Program for Comparative Medicine. Responsibilities for this position include coordinating, scheduling and protocol input of both non-GLP and GLP regulated studies, assisting with process development during implementation, overseeing the internal preclinical software (ie: Xybion) ticketing system (KACE) and addressing or assigning tickets as appropriate, maintaining communications with customer service, staying up to date on the latest software version releases, and providing technical support across PCM as it relates to electronic documentation & retrieving/reviewing data reports in accordance with Good Laboratory Practices (GLP) regulations. This may include providing technical support outside of normal GTP business hours. The Preclinical Systems Coordinator will be instrumental in the implementation and ongoing use of preclinical software including providing feedback to the Core Program Manager for process improvement. Additional responsibilities include maintenance of the Production Environment (including ongoing Performance Qualification testing as needed), creation of GTP protocol templates, updating SOPs to reflect business/system processes and changes as it relates to electronic data capture and software updates, leading Change Control processes & documentation as needed, as well as assisting with creating training resources for the onboarding of new users to the system and executing classroom and hands on training. As the GTP moves from a primarily paper based system to 21 CFR Part 11 compliant electronic data capture in-life and post-life system, this position will be the primary PCM contact for questions related to the system as it relates to troubleshooting issues that arise during the conduct of the studies, ensuring appropriate documentation is maintained and up-to-date and can be retrieved in an expedited manner.
This position will have an Administrator role in the electronic data capture system. Privileges associated with this role may evolve as business needs are identified or expanded. This position will work in a team along side the GLP Study Coordinator and Core Program Coordinator.
- Bachelor's degree in Chemistry, Biology, Biochemistry, Animal Science or related discipline and at least 3-5 years of pharmaceutical/biotechnology experience in the area of Laboratory Inventory Management Systems administration, Quality Assurance documentation, and/or related.
- The successful candidate should have strong experience with the management of GLP animal studies and have strong technical lab experience.
- The candidate should be a highly motivated individual with good communication skills, record keeping skills, computer skills with the ability to analyze and solve problems.
- Knowledge and experience working with LIMS or LIMS-like platforms; Microsoft Excel, Word, PowerPoint, Exchange
- An ability to be productive and successful in an intense work environment.
- Highly organized and result-oriented.
- Problem solving and critical thinking skills.
- Excellent interpersonal skills.
Job Location - City, State
Department / School
Perelman School of Medicine
$50,684.00 - $91,232.00
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