Senior Executive Director, Vector (Gene Therapy Program)
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.
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for the latest information. Posted Job Title
Senior Executive Director, Vector (Gene Therapy Program)Job Profile Title
Director FJob 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. GTP is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through Phase 1 proof-of-concept human trials.
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 Senior Executive Director, Vector Analytical & Manufacturing Sciences (SEDV) to direct 3 major functional areas of our organization (1) Manufacturing Sciences and Technology (2) Analytics Sciences and Technology and (3) CMC Project Management and External Manufacturing. Each functional area will be led by an Executive Director or Senior Director. In addition, the SEDV will work closely with the following Chief Officers and Executive Directors: Executive Director of GMP Quality Assurance, Chief Regulatory and Compliance Officer, Chief Business and Strategy Officer, Executive Director of Fiscal Operations and Executive Director of Scientific Administration to ensure quality, regulatory, fiscal and HR compliance across the functional units.
As part of a cross-functional team, the SEDV will support the establishment of strategies for current and future manufacturing initiatives to deliver high-quality viral vectors for gene therapy research, clinical trials and commercial products.
The SEDV will direct the teams listed above to develop advanced process and analytical technologies, execute manufacturing activities and analytical research, manage sponsored and contracted projects and interface with external organizations including Penn's industry partners, government agencies including the NIH/NHBLI, contracted development and manufacturing organizations (CDMOs) and contract research organizations (CROs) as well as US and exUS regulatory authorities as needed. The CTO will develop strategies, metrics and systems to support research, clinical and commercial programs, develop presentations and reports, write and submit grant and contract applications and contribute to regulatory submissions. Top candidates will have a strong background in biologics manufacturing operations within biotech or pharmaceutical industries, experience in managing large and diverse teams, an in-depth understanding of AAV vector biology and have high quality and efficiency standards.Qualifications
Job Location - City, State
- 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 possess 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.
Philadelphia, PennsylvaniaDepartment / School
Perelman School of MedicinePay Range
$126,841.00 - $202,945.66Affirmative 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.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Translational-Research-Laboratories/Senior-Executive-Director--Vector--Gene-Therapy-Program-_JR00045857-1
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