Director

Location
Pennsylvania, United States
Posted
29 Jan 2019
End of advertisement period
29 Mar 2019
Ref
40-30795
Contract Type
Permanent
Hours
Full Time

Org DM-Gene Therapy
Program Posted to the Web 01/28/2019
Posted Job/Salary Grade 029
Employment Type Exempt
Hours N/A
Position Type Full Time Position
Schedule 8am - 5pm
Months 12
Position Length Contingent Upon Funding

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.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with 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.

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 significant growth, the Vector Core is looking for a new Director of Downstream Manufacturing to lead upstream vector production, process optimization & development, and technology transfer in support of pre-clinical & IND-enabling research, early to late phase global clinical trials, and commercialization. 

As the Director, you will lead and drive current and future strategy as it pertains to downstream manufacturing science and technology. You will oversee the activities of and develop/mentor a high-performing team in downstream clinical vector manufacturing, process optimization & development, and tech transfer. You will use sound scientific and engineering criteria to design and develop manufacturing processes and oversee process optimization strategies to ensure successful execution of projects. Interface with external sponsors and CMO’s to support global initiatives, preparing presentations and other materials for external meetings, regulatory filings, publications, and grant applications. You will work closely with the Analytics Director to manage in-process testing and the development of analytics required for new downstream manufacturing processes. You will support regulatory interactions and contribute to the content of manufacturing-related sections of regulatory documents. 

The preferred candidate will have industry experience in overseeing manufacturing of biologics, developing manufacturing processes suitable for clinical translation and in managing production activities at CMOs.

Qualifications

  • A Master’s Degree in Bioengineering, Biology, Biochemistry and 7-10+ years of industry experience in process development required
  • Ph. D. strongly preferred
  • Minimum of 5 years of supervisory experience required
  • Extensive knowledge of biologics manufacturing, FDA regulations (GLP and GMP)
  • Experience in interactions with outside vendors, e.g. CMOs, CROs
  • Ability to think strategically and to translate strategy into actions. 
  • 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 who can think strategically
  • Excellent oral/written communication skills required

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.