Position Summary. Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensure that all team members comply with safety rules and regulations. The Technical Investigator is responsible for the initiation, invest...
Position Summary. ProKidney is seeking an experienced Research Associate for our Cell Therapy Process Development team. The ideal candidate will have a strong background in cell therapy or biopharmaceutical development, process optimization, and technology transfer. In this role, you will lead or support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a gr...
POSITION SUMMARY. The Validation Engineer will support equipment, process, and cleaning validation activities. This role will help develop, author, review and execute all validation protocols and reports with guidance from senior level staff. The Validation Engineer will help coordinate all validation activities and projects with departmental manager. RESPONSIBILITIES. Lead validation projects to include planning, scheduling execution and reports...
Position Summary. As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies,...
Position Summary. This on-site Quality Assurance On the Floor (OTF) Specialist 2 reports directly to the Manager, QA Floor Support. This position will be based at our cGMP Manufacturing site and will directly support the CMC clinical manufacturing program. The main responsibility for this position is to provide real-time on the floor quality oversight of all Manufacturing activities, with a focus on adherence to aseptic technique, GMP principles ...
