Associate Director, External Manufacturing

Pennsylvania, United States
17 Jun 2020
End of advertisement period
17 Aug 2020
Contract Type
Full Time

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.

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

Associate Director, External Manufacturing

Job Profile Title

Associate Director E

Job Description Summary

Associate Director E

Job Description

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.

Vector technology lies at the heart of GTP due to the contributions of the Wilson Lab. GTP has a long track record of success in developing novel vector technologies, manufacturing platforms and analytics as well as distributing vectors for research purposes. Once successful in the research environment, the vectors must be transferred to the clinic which requires expertise both regarding vector manufacturing and characterization. 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, produces vectors in support of IND-enabling research, develops and conducts GLP assays, oversees CMO's in vector production and is expanding to perform state-of-the-art process development.

Due to significant growth, the Vector Core is looking for a new Associate Director, External Manufacturing (ADEM) to lead the development of external CMC project plans for GTP programs. 

As the ADEM, you will develop the external manufacturing plans and lead the interaction of the CMC cross-functional projects among GTP personnel, and between GTP and the Contract Manufacturing Organizations (CMOs). You will travel to CMOs during campaign launches and throughout the campaign, as needed to monitor and manage CMC process transfer, supply chain, budgets,  and ensure project milestones and timelines are being met from early to late-stage production at CMO. You will create and maintain comprehensive risk management plans for product production to minimize the impact of obstacles to overall campaign goals. 

Top candidates in this role will have a strong background in biopharmaceutical manufacturing, process and analytical development, and process transfer as well as have experience in planning and managing CMC aspects of biopharmaceutical development.  

This posting describes the responsibilities and requirements for an Associate Director, External Manufacturing role. If you meet the qualifications outlined and have an interest in being considered for new positions that become available, please apply to this posting. Your information will be reviewed and you will be contacted directly if we would like to learn more about your background, in consideration for the current and/or future openings.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

Affirmative Action Statement 

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements 

Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

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