ProKidney

The Director, CMC Project Management will be responsible for managing activities related to CMC Planning. In conjunction with internal subject matter experts and consultants, the Director will be responsible for identifying CMC Gaps and implementing cross functionally aligned CMC strategy to support

The Lead Facilities Technician is a highly skilled, hands-on role that provides day-to-day technical leadership for the safe, reliable, and efficient operation of building systems and infrastructure at the Winston-Salem site. The position serves as the primary technical resource for the Building Man

The Quality Assurance (QA) Specialist III provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP com

Position Summary The Sr. Manager of Validation will lead ProKidney's on-site Validation team, serving as both a people leader and a hands-on technical contributor. In this role, you'll establish operational objectives, drive cross-functional alignment, and lead the full lifecycle of validation docum

Position Summary The Senior Director, Quality Operations is responsible for providing strategic and operational leadership across all aspects of GMP Quality Assurance for the production of ProKidney drug products, both clinical and commercial, across all manufacturing sites. This role serves

Position Summary The Quality Assurance (QA) Specialist I Contractor is an entry-level role that supports quality assurance operations within classified manufacturing environments, including cleanrooms. Working under close supervision, the Specialist learns and applies foundational Good Manufacturing

Position Summary: The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-

Position Summary: The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-

Position Summary: ProKidney is seeking a Senior Director, Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining close to the work. The Senior Director

Position Summary: The QC Analyst Contractor supports Quality Control activities including routine environmental monitoring, operation of QC equipment, QC sample handling, protocol execution, GMP documentation, data collection, inventory support, and coordination with Quality Assurance. The role foll

Position Summary The Quality Assurance (QA) Specialist II supports routine quality assurance operations within classified manufacturing environments, including cleanrooms. Working with moderate supervision, the Specialist II applies Good Manufacturing Practices (cGMP) to perform defined QA activitie

The ProKidney Medical Monitor is a licensed US based physician, preferably internist with knowledge of cardio-metabolic-renal diseases or trained nephrologist who oversees the safety, integrity, and compliance of clinical trials, ensuring that research is c

Position Summary The Manager, Executive Operations provides executive administrative and operational support to the Chief Technical Officer (CTO) and members of the Manufacturing & Operations leadership team. This role may also support other members of the Executive Leadership Team as business n

Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells, potentially preventing or delaying the need for dialysis or transplant. Quality

Summary Provides strategic and operational leadership for global clinical development, guiding programs from IND through Phase III while ensuring scientific rigor, quality, GxP compliance, and effective collaboration with internal stakeholders, investigators, KOLs, CROs, and consultants. Lead and bu

The Manufacturing Supervisor is responsible for leading daily manufacturing operations within a cGMP-regulated biologics production environment. This role provides direct supervision of manufacturing personnel, ensures safe and compliant execution of production activities, and supports delivery of t

Position Summary: The Site Office Administrator provides day-to-day administrative and operational support for the Winston-Salem, NC sites. This role assists with office services, non-GMP vendor coordination, visitor management, meeting and event logistics, documentation, and facilities-related supp

The Sr Director of Quality Control will be responsible for leadership of the various functional responsibilities of the Quality Control department, including QC - Operations, QC - Incoming Raw Materials, QC - Systems & Services, and QC – Microbiology Sterility Assurance. The role will lead conti

ProKidney is seeking a Manager, Clinical Data Management. In this role, you will own data management study deliverables end-to-end — from data capture tool development through database lock — while partnering closely with CROs and third-party vendors to keep clinical data accurate, timely, and audit

The Manufacturing Specialist 2 plays a crucial role in supporting manufacturing operations with a focus on aseptic processing and adherence to cGMP guidelines. This position involves participating in the aseptic processing of in-house solutions and patient processes, ensuring compliance with Standar