Senior Director - Physical/Chemical Characterization (Gene Therapy Program)

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Senior Director - Physical/Chemical Characterization (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.

Posted Job Title
Senior Director - Physical/Chemical Characterization (Gene Therapy Program)

Job Profile Title
Director D

Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with 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 to support discovery research through IND-enabling studies and phase I/II human clinical trials.

Continuation of all GTP positions is contingent upon funding.

Job Description

Our Vector Operations group, comprised of Manufacturing Sciences and Technology (MS&T), Analytical Sciences and Technology (AS&T) and External Manufacturing (EM) teams, provides manufacturing and analytical support of basic, translational and clinical research. The MS&T team is composed of teams that conduct platform development, process development and optimization, vector manufacturing and process technical transfer. The AS&T team conducts analytical development, quality control and assay technical transfer. The AS&T organization includes a molecular team, biochemical team, bioassay team and physical/chemical team. The AS&T organization also includes supporting functions including analytical operations, out-sourced testing and plasmid DNA source material testing and procurement.

The Senior Director of the AS&T Physical/Chemical team will oversee the development, conduct and qualification of physical and chemical assays in the Physical/Chemical team as well as provide oversight to the Bioassay team. Analytical testing may be conducted as research testing or as GLP/GMP testing with Quality Assurance oversight. As Senior Director, you will need to demonstrate proficiency in the Core Assays (e.g. MS, SEC) in order to train, troubleshoot and conduct assays when needed as well as to ensure appropriate training and documentation (technical reports, test records) is complete. You will also develop robust training programs with criteria to ensure operators are trained and/or qualified. You will participate in technical advancement including the implementation of new methods and establishment of new technologies. You will be expected to demonstrate a thorough understanding GxP including good documentation practices (GDP), good laboratory practices (GLP) and good manufacturing practices (GMP) as well as an understanding of regulatory guidelines and requirements. You will participate in authoring and reviewing development and technical reports, SOPs and test records, study reports, qualification reports, and relevant sections of regulatory submissions.

You will work both independently and as part of a team to accomplish project goals within specified timelines, workplans and budgets. Successful candidates will have experience in physical/chemical characterization of biologics and expertise in relevant technologies (e.g. MS, SEC, HPLC, AUC, DLS, ceSDS). Candidates will have prior experience managing staff as well as managing multiple projects simultaneously. Importantly, successful candidates will have a strong understanding of GxP and regulatory guidelines as well as excellent written and oral communication skills.

Qualifications:

  • MS in chemistry, biology, chemical engineering or related disciplines with 7-10 years of experience required in the biopharmaceutical industry or similar.
  • PhD preferred.
  • Must have a thorough understanding of GxP and regulatory guidelines for the manufacturing and testing of gene therapy products.
  • Must have expertise in physical/chemical characterization of biologics (including MS, AUC).
  • 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
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$88,861.00 - $168,837.00

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.




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-Director---Physical-Chemical-Characterization--Gene-Therapy-Program-_JR00039958-1

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