Process Development & Efficacy (PDE) Manager

Process Development & Efficacy (PDE) Manager

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 Large Employers in 2023.

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

Process Development & Efficacy (PDE) Manager

Job Profile Title

Technical Operations Manager - Clinical Cell and Vaccine Production Facility

Job Description Summary

The Clinical Cell and Vaccine Production Facility (CVPF) and Center for Advanced Cellular Therapies (CACT) of the University of Pennsylvania manufacture advanced cell and gene therapy products in support of pioneering investigational new drug (IND) protocols, with all products undergoing rigorous quality testing prior to release. The vision of the CVPF is to produce high-quality, innovative therapies that advance the field and improve patient lives. Building on Penn's legacy of breakthrough immunotherapy approvals, this role plays a critical part in advancing novel technologies, automation strategies, and efficient processes to maintain Penn's leadership in the field.

Job Description

The Process Development & Efficacy (PDE) Manager serves as a bridge between process development and manufacturing operations within the CVPF Manufacturing group. The role provides leadership and expertise in process improvement and innovation, technology transfer and scaling up, automation, troubleshooting, and advanced training to ensure alignment with CVPF's projects and manufacturing priorities. The PDE Manager will manage projects that target the transition of research concepts into robust, compliant, and scalable GMP operations while participating in GMP manufacturing operations. The PDE Manager drives continuous improvement, process optimization, and transparent communication of project scope, milestones, and deliverables across CVPF. The role will also require an accurate, complex-level documentation for internal and regulatory reporting following Good Documentation Practices. Demonstrated expertise as an operator and knowledge on GMP cell processing equipment, laboratory techniques, and manufacturing processes required. Strong critical thinking skills are essential to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements.

The PDE Manager, with minimal direction, is expected to resolve problems that occur in the cleanroom, oversee cell processing activity, provide strategic directions for the implementation of novel processing methods and new trials, implement contingency plans for unexpected processing events, and lead new trial initiation activity; collaborate in the design of processing methods and validation of new equipment and manufacturing processes to support tech transfer into the cell processing facility.

Efficient time management and the ability to multitask to complete activities for multiple clinical studies at a given time are essential. This position requires great communication skills to manage internal and external collaborations with vendors and regulatory personnel to assure regulatory compliance of manufacturing processes; assist supervisors with compliance audits performed by regulatory bodies and collaborators.

Routine interaction with senior management, cell processing technologists, quality control scientists, quality assurance personnel, and additional support staff is necessary. This is an Essential University employee position and is required to report to work in times of inclement weather and University closure. Flexibility to work off-shift, additional hours, or on-call hours may be required.

Position is contingent upon funding.

Qualifications

Bachelor's degree in Biology or related science required, Master's degree preferred. A minimum of 5 years of prior demonstrated cell processing / cell culture GMP expertise is required. 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.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,500.00 - $100,000.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements

Background checks may be 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

Equal Employment Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state, or local law.

To apply, visit https : / / wd1.myworkdaysite.com / en-US / recruiting / upenn / careers-at-penn / job / Smilow-Center-for-Translational / Process-Development Efficacy PDE Manager_JR00113552-2

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