| 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 Pennâ™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 Manager, Process Systems MS&TJob Profile Title Manager Research Project CJob 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 âœgo-toâ 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 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 new Manager, Process Systems MS&T to support the production of viral vectors for pre-clinical & IND-enabling research, early to late phase global clinical trials, and commercialization.   As the Manager, you will become a hands on expert of the vector platform manufacturing process and use this knowledge to collaborate with subject matter experts in process development, manufacturing operations, analytics and quality assurance. You will revise and review internal and external technical documents including standard procedures, investigations, and batch records. You will aid in writing development, investigation reports and contribute to regulatory CMC sections. You will evaluate and help implement process changes and continuous improvement to support manufacturing operations to ensure quick, flawless, compliant, and cost-effective delivery of quality viral vectors. Qualified candidates will have hands-on experience in biologics manufacturing and/or process development and a solid foundational knowledge of cGMP and biopharmaceutical regulations. 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 new Manager, Process Systems MS&T to support the production of viral vectors for pre-clinical & IND-enabling research, early to late phase global clinical trials, and commercialization.   As the Manager, you will become a hands on expert of the vector platform manufacturing process and use this knowledge to collaborate with subject matter experts in process development, manufacturing operations, analytics and quality assurance. You will revise and review internal and external technical documents including standard procedures, investigations, and batch records. You will aid in writing development, investigation reports and contribute to regulatory CMC sections. You will evaluate and help implement process changes and continuous improvement to support manufacturing operations to ensure quick, flawless, compliant, and cost-effective delivery of quality viral vectors. Qualified candidates will have hands-on experience in biologics manufacturing and/or process development and a solid foundational knowledge of cGMP and biopharmaceutical regulations. Qualifications: - Bachelor's Degree in Engineering or related discipline required.
- 7+ years of experience in biologics manufacturing support, tech transfer, and/or validations.
- Expert knowledge of cGMP and biopharmaceutical and/or gene therapy regulations required.
- Must have hands on experience with biologics manufacturing or process development.
- Experience working with external parties and with cross-functional teams strongly preferred.
- Possess strong verbal/written communication skills and the ability to influence at all levels.
Job Location - City, State Philadelphia, PennsylvaniaDepartment / School Perelman School of MedicinePay Range $72,837.00 - $138,391.00Affirmative 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. |
