ProKidney

The Quality Assurance Specialist II, Batch Release (contractor) supports Quality Operations by conducting detailed reviews of executed manufacturing, packaging, labeling, and laboratory records used in material and product disposition. The role verifies that documentation is complete, accurate, trac

Position Summary The Quality Assurance Specialist I, Batch Release performs routine review and administrative activities that support material and product disposition. Working under established procedures and regular guidance, the role reviews executed manufacturing and laboratory documentation for

Position Summary: The Manufacturing Specialist 1, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating producti

The Associate Director, IT GxP & Quality Systems, leads strategic programs within the Company's regulated technology landscape and serves as the primary technology partner for Quality Systems. This role is accountable for the delivery, governance, optimization, compliance, and lifecycle management o

The Material Handler 1 supports warehouse and manufacturing operations by performing routine, well-defined material handling tasks across multiple campuses. This role assists with receiving, storing, and moving materials to support packaging and manufacturing operations in compliance with GMP requir

The Director of Sterility Assurance is accountable for defining, implementing, and sustaining the sterility assurance and contamination control strategy for autologous cell therapy manufacturing operations supporting clinical and commercial programs at ProKidney. This role provides strategic and ope

The Associate Director, Raw Materials Lead is accountable for establishing and leading the technical strategy, governance framework, and lifecycle management program for raw materials used in GMP manufacturing. The role translates CMC and manufacturing strategy into risk-based material control plans

The Director, CMC Project Management owns the integrated Technical Operations plan that carries ProKidney's late-stage autologous cell therapy program through BLA submission, Pre-License Inspection (PLI) and approval, and will establish the CMC program and portfolio management framework (governance,

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

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 as a ke

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