Director, QC Testing (Gene Therapy Program)

Director, QC Testing (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, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Director, QC Testing (Gene Therapy Program)

Job Profile Title
Director C

Job 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

The GTP Vector Core is starting-up 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 GMP 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 seeking to a add a Director, QC Testing to oversee the institution of a GMP compliant testing lab supporting the manufacturing and stability of advanced gene therapy programs.

As the Director, QC Testing you will partner closely with Manufacturing, Process Development, and Analytical Development to support GTP programs to ensure we meet project timelines. You will assemble, review, and generate reports as necessary to
support regulatory filings. Analytical method support will include, but not limited to, continuous monitoring of method performance (e.g., control charting, invalid rates, etc.), investigation management, data integrity reviews and authoring and/or review of relevant regulatory documents, Standard Operating Procedures and Protocols (i.e., method qualification, implementation and validation, specifications, batch analysis and reference standards). You will work with Vector leadership to implement IT solutions for compliance purposes and become a Subject Matter Expert for QC/Analytical. You will need a team of scientists with diverse responsibilities to support QC Operations.

Qualified candidates will have a strong background in biologics analytics and quality control testing and experience working under GLP or GMP standards. Experience with supporting Gene therapy programs would be highly desirable.

Qualifications:

● Master's Degree in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences or other relevant discipline and 5 to 7 years of experience or equivalent combination of education and experience required. PhD preferred.
● Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
● Proven leadership, organizational and management skills to coordinate cross functional decision making with executive leadership.
● Understanding and familiarity with FDA, EMA, MHRA, ICH and other international regulatory requirements, guidelines, and recommendations for quality system implementation.
● Understanding and experience with oversight of the pharmaceutical quality system including good manufacturing, laboratory, and data integrity practices.
● Experience with using or implementing GMP compliant laboratory software systems.
● Experience validating methods and monitoring commercial method performance.
● Experience drafting protocols and technical reports and QC policies and procedures required.
● Experience with statistical analysis of analytical data and stability studies preferred.
● Cross-functional, hands-on experience at a small biotech/biopharma company.

Job Location - City, State
King of Prussia, Pennsylvania

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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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/Discovery-Labs---Building-27A/Director--QC-Testing--Gene-Therapy-Program-_JR00064796-1



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