Executive Director, Manufacturing
Job location: Translational Research Laboratories
Employment Type: Full-time
Posted data: 2020-09-10
University OverviewThe 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 TitleExecutive Director, ManufacturingJob Profile TitleDirector EJob Description SummaryThe 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.Job Description
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 continued growth of our program, we are searching for a new Executive Director, Manufacturing Operations to establish a world-class manufacturing organization, both by optimizing our current research/preclinical capabilities and build-out a Contract Development and Manufacturing Organization to support early/late phase clincal trials of gene therapy products.
As the Executive Director, you will establish the strategies for current and future sites for the manufacturing team to deliver high-quality viral vectors for gene therapy research and clinical trials. You will set up site goals and objectives, ensuring those are aligned cross functionally with other CMC functions. You will optimize existing and implement new policies and systems to ensure high quality GMP manufacturing, working closely with Regulatory and Compliance teams. You will oversee the development of robust continuous training and onboarding programs for new and existing staff members. You will work cross-functionally with Process and Analytical development leaders and teams to ensure a robust technology transfer strategy aligned with current industry best-practices. You will model behaviors and cultivate a culture of continuous improvement and driving product/process improvements to improve reliability, quality, productivity and efficiency. You will create an open, “speak-up” environment to ensure that the best innovative solutions are identified and implemented.
Top candidates will have a strong background in biologics manufacturing operations leadership within the biotech or pharmaceutical industries and have high quality and efficiency standards.
- BS degree in life sciences, engineering or related field; advanced degree in life science, e.g. MS, MBA and/or PhD preferred, with at least 10+ years of experience managing manufacturing operational teams in the biotech or pharmaceutical industries required.
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products.
- Extensive experience in clean room manufacturing, aseptic processing and fill/finish is required.
- Knowledge of cell and gene therapy manufacturing is strongly preferred
- You will have a broad understanding of the business model, science, facilities, engineering, process development, supply chain, quality, compliance, regulatory, and information technology expectations for biologics manufacturing.
- You have been a Change Agent and posses influencing skills. Adaptive, agile, flexible, open minded. Consistent record to build cross-functional commitment, lead, simplify and scale complex dynamic organizations through transformational change.
- A high energy level with a positive “can do” attitude, ability to adapt and think “out of the box” and rapidly turn ideas into action in a nascent, evolving, innovative industry. Manage ambiguity with aplomb and calmness. Creative, innovative and risk-taking.
- Ability to give and earn trust. High level of emotional intelligence, exceptional listening, verbal and written communication skills.
- Ability to adopt other people’s point of view - especially if different than one’s own.
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.