Manager, QC Studies
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Posted Job Title
Manager, QC Studies
Job Profile Title
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.
Our Vector Core is a state-of-the-art facility which provides vector-related materials and services in support of basic and translational research worldwide, producing vectors in support of IND-enabling research, conduct GLP assays, oversee CMO's in vector production and is expanding to conduct state-of-the art process development.
Due to continued growth of our program, we are searching for a Manager of Quality Control Studies (MQCS) to lead drug product, stability, and biodistribution for IND-enabling studies.
As the Manager, you manage and direct the activities of the Quality Control Studies Sample management teams. You will partner with the Director of GLP QC and Associate Director of Assay Development to design and implementation of drug product, stability, and biodistribution studies for AAV vectors. You will design and implement training modules for biodistribution studies, providing training to GTP staff and maintain compliance tracking. You will manage the reagents used and partner with QA closely to effectively execute these studies as well as archiving samples.
As a successful candidate, you will have experience in drug product, stability, and biodistribution studies under GLP conditions for biologic therapies.
- Bachelor's Degree and 5 to 7 years of applicable experience preferably in the pharmaceutical industry, or an equivalent combination of education and experience is required.
- Supervisory experience preferred.
- Extensive knowledge of cell-based and molecular assays required.
- Understanding of GLP regulatory standards preferred.
- Self-starter but also a strong desire to contribute and work collaboratively to achieve goals.
- Success in roles requiring execution of multiple tasks while responding to multiple priorities.
- Highly functioning, detail-oriented, and analytical candidate.
- Excellent oral/written communication skills required.
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
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