Director, Clinical Manufacturing Operations (Center for Cellular Immunotherapy)

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Director, Clinical Manufacturing Operations (Center for Cellular Immunotherapy)

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
Director, Clinical Manufacturing Operations (Center for Cellular Immunotherapy)

Job Profile Title
Director D

Job Description Summary
The focus of this role is to oversee clinical manufacturing activities and assume responsibility for the manufacturing operations of new studies, processes and new technology in a state-of- art Clinical Cell and Vaccine Production Facility.

Job Description

Lead implementation of startup operations for new trials through technical and organizational leadership, assuring the execution of validation runs for the implementation of cell manufacturing improvements and interpretation of validation run results. Provide technical guidance for devising production schemes at the required scale and review /approves process specific protocols, policies, and Standard Operating Procedures (SOPs). Oversees the integration of new process development with other functional groups within CVPF, including Facilities, Operations, Quality Control, Quality Systems and Quality Assurance. Drive technology transfer within the Penn community and industry partners. As a member of the CVPF Steering committee develops strategic plans to increase manufacturing capacity, increase adherence to quality standards and improve overall workflow. Provide strong in-house science and technical guidance to Associate Director for CVPF clinical trials and process improvement projects. Communicate with Principal Investigators and all members of clinical team. Additional responsibilities may apply.

Qualifications:

Advanced degree in Biology or related science required and a minimum of 7- 10 years prior demonstrated cell processing/cell culture expertise or an equivalent combination of education and experience required. Master's degree or higher preferred. Cell therapy experience is required. Ability to work effectively in a fast-paced environment and consistently meet deadlines is required. Flexibility, Dedication, Accountability and Team-oriented interpersonal skills are essential in this position. Position may require "off-standard hours" and "on-call" hours related to specific clinical trials, including some nighttime or weekend hours.

Additional requirements:
  • prior experience in academia preferred; prior experience in GMP facility management required
  • Experience in phase I/II clinical trial management in cell therapies, translational research, GMP manufacturing
  • Previous GMP lab experience required
  • Strong background and demonstrated experience in cell and gene therapies and ability to initiate cell and gene therapy trials
  • Previous experience in GLP, and GDP compliance. Highly functioning, detail-oriented, and analytical candidate who can think strategically and holistically about organizational expansion and across multiple departments/units
  • Strong planning, organizational and inter-personnel skills are essential
  • Self-starter but also a strong desire to contribute and work collaboratively to achieve goals
  • Proven excellence in successfully leading/working in interdisciplinary teams and projects
  • Demonstration of active contributions to cross-function teams, ability for long-range strategic thinking
  • Be recognized as a respected subject matter expert and have extensive experience with developing and directing the manufacturing of cellular therapy products
  • Ability to work with multifunctional groups and coordinate clinical manufacturing activities simultaneously under pressure
  • Exceptional communication and organizational skills and strong attention to detail


Position contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$90,860.00 - $142,844.66

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/Smilow-Center-for-Translational/Director--Clinical-Manufacturing--Operations--Center-for-Cellular-Immunotherapy-_JR00051827

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