Associate Director, GMP Manufacturing - Downstream (Gene Therapy Program)

Associate Director, GMP Manufacturing - Downstream (Gene Therapy Program)

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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.

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.

COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Associate Director, GMP Manufacturing - Downstream (Gene Therapy Program)

Job Profile Title
Associate Director E

Job Description Summary
The Gene Therapy Program (GTP), at the University of Pennsylvania, is entering a new era of unprecedented opportunity with great potential to reshape the face of medicine. Our discoveries have set the stage for successful treatments for devastating genetic and infectious diseases.

The laboratory of Dr. James Wilson, in the Gene Therapy Program, has been a leader in the development of innovative vector technology for close to three decades. As a result, GTP has emerged as the "go-to" organization for public and private partners, who want to participate in the gene therapy space including in the development of therapies for both rare and non-rare diseases. We are currently positioned to lead another round of vector innovation to support discovery research through IND-enabling studies and human clinical trials.

Continuation of all GTP positions is contingent upon funding.

Job Description

Our Vector Program group, including Manufacturing Sciences and Technology (MS&T), Analytical Sciences and Technology (AS&T) and External Manufacturing (EM) teams, provides Chemistry, Manufacturing and Controls (CMC) support for basic, translational and clinical research for adeno-associated virus (AAV) vector-based therapeutic products. The MS&T team is composed of scientists and engineers that conduct process development and optimization, scaled research vector manufacturing and technology transfer to GMP. To support the enormous growth of GTP, the MS&T team will be adding functional units that will conduct GMP manufacturing activities in a dedicated GMP space using GTP's platform manufacturing technologies.

We are currently recruiting an Associate Director of GMP Manufacturing-Downstream, who will be part of a high performing downstream GMP team. The role will require working with MS&T to execute technology transfer practices as well as working with Quality Assurance (QA) and other support teams to ensure compliant drug substance GMP production The manufacturing platforms developed by GTP include, but are not limited to, transient transfection and virus-coinfection systems for the production of AAV vectors. The successful candidate will oversee a high performing team of downstream manufacturing process scientists and/or engineers with a robust understanding of the process science and equipment to execute GMP compliant manufacturing to generate life saving therapies. The close proximity and collaborative work environment between MS&T and GMP teams is anticipated to promote efficient technical transfer and implementation of new or optimized manufactured methods from PD to Manufacturing. Candidates will have experience in the generation of complete and accurate process flow diagrams, process descriptions, batch records, technical reports and technical transfer documents as well as have participated in the authoring and/or review of regulatory submissions. Candidates will participate in technical advancement including the implementation of new methods and in the establishment of new technologies. Candidates will be dedicated to building a culture of operational excellence.

Successful candidates will have an advanced degree in Chemical Engineering or related discipline and a thorough understanding of good manufacturing practices (GMP) and regulatory requirements to the extent needed to execute processes for clinical and commercial manufacturing. Candidates will have experience executing best practices, managing staff as well as experience managing multiple projects and projects simultaneously. Candidates will be part of a team of biopharmaceutical manufacturing experts.

  • BS or higher degree chemical engineering or related disciplines with 7-10 years of experience required in the biopharmaceutical industry or similar.
  • A good understanding of GxP and regulatory guidelines for the manufacturing and testing of gene therapy products is preferred.
  • Must have expertise in process development and manufacturing of biologics.
  • Must be highly motivated, have excellent organizational, communication (written and oral) and interpersonal skills.
  • Must be able to work independently and as part of a multi-disciplinary team.

Job Location - City, State
King of Prussia, PennsylvaniaAssociate Director E

Department / School
Perelman School of Medicine

Pay Range
$74,476.00 - $117,086.00
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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.

University Benefits
  • Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  • Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  • Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  • Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
  • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  • Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  • Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  • University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free.
  • Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  • Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  • Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  • Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.

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