"Process Development & Efficacy (PDE) Manager"

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.

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