Process Development & Efficacy (PDE) Manager

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.