ProKidney
13 open jobs
Associate Director, IT GxP & Quality Systems
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
Applyto Associate Director, IT GxP & Quality Systems at ProKidney seen live 16h ago posted 5 days agoMaterial Handler 1 Contractor
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
Director of Sterility Assurance
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
Associate Director, Raw Materials MSAT
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
Director, CMC Project Management
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
Lead Facilities Technician
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
Quality Assurance Specialist 3, Floor Support
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
Applyto Quality Assurance Specialist 3, Floor Support at ProKidney seen live 16h ago posted 30 days agoSenior Manager, Validation
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
Statistical Programming Contractor
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
Sr. Director, Biostatistics
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
Manufacturing Cell Processing Team Lead
The Team Lead, Cell Processing at ProKidney plays a critical role in leading advanced manufacturing operations, focusing on cell processing, aseptic processing, and ensuring compliance with cGMP guidelines. This role involves overseeing day-to-day operations of the manufacturing
Associate Director, Validation
Position Summary The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee
Sr. Director, Quality Operations
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.