ProKidney is a healthcare technology company specializing in developing innovative solutions for kidney disease management. With a commitment to revolutionizing renal care, ProKidney leverages cutting-edge technology and medical expertise to provide advanced tools and services that enhance patient outcomes and streamline healthcare processes in the field of nephrology.

prokidney

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 requirements and company safety standards.
Key Responsibilities
Material Handling and Receiving
<ul>
<li>Execute material receiving functions, including receipt of packaging line parcels and reconciliation with purchase orders</li>
<li>Perform GMP-compliant receiving, visual inspections, labeling, and recording of inventory transactions in the Sage X3 ERP system</li>
<li>Execute proper stock put-away in compliance with SOPs and Material Delivery Specifications (MDS)</li>
<li>Issue materials following established First-Expired, First-Out (FEFO) procedures and work instructions</li>
<li>Label and identify materials with corresponding lot numbers, expiration dates, serial numbers, and part numbers</li>
</ul>
Inventory Maintenance and ERP Transactions
<ul>
<li>Input accurate inventory balances in the Sage X3 ERP system by following established inventory transaction procedure</li>
<li>Communicate material shortages, low inventory levels, or upcoming expirations to the appropriate supervisor or team following established procedures</li>
<li>Assist with executing outbound shipments and returns through FedEx, UPS, or other logistics providers under supervision</li>
</ul>
Warehouse Operations and Safety
<ul>
<li>Safely and efficiently operate warehouse equipment, including pallet jacks, following all safety guidelines</li>
<li>Maintain a clean and organized work area, dock, and receiving area in a state of perpetual audit readiness</li>
<li>Handle the disposal of receiving and shipping-related waste in accordance with company guidelines and safety standards</li>
<li>Comply with all company SOPs, policies, and safety standards to maintain a safe working environment</li>
<li>Demonstrate flexibility to assist with routine warehouse tasks across multiple campuses as needed</li>
</ul>
Communication, Teamwork, and Compliance
<ul>
<li>Follow detailed instructions on all assigned tasks; seek supervisor guidance on new or unfamiliar assignments</li>
<li>Report work-related issues or concerns to the immediate supervisor following established escalation procedures</li>
<li>Attend departmental meetings and complete all required training on time</li>
</ul>
Additional Duties
<ul>
<li>Perform other routine warehouse duties as assigned to support department and company goals</li>
</ul>
Qualifications
Education / Training
<ul>
<li>High School Diploma or equivalent required</li>
</ul>
Experience
<ul>
<li>No previous warehouse experience required</li>
<li>Prior exposure to pallet jack operation, GMP environments, or warehouse settings a plus</li>
</ul>
Knowledge
<ul>
<li>Basic awareness of warehouse operations and inventory management concepts</li>
<li>Basic familiarity with computer functions and data entry; prior exposure to ERP systems (Sage X3 or similar) is a plus</li>
<li>Basic awareness of GMP guidelines and safety requirements as applied to warehouse tasks</li>
</ul>
Skills
<ul>
<li>Ability to lift and move material containers weighing up to 50 pounds consistently</li>
<li>Attention to detail and ability to follow documented procedures and work instructions</li>
<li>Ability to handle biohazardous materials safely and in compliance with applicable regulations</li>
<li>Basic communication skills</li>
<li>Ability to work cooperatively and reliably within a team environment</li>
<li>Must wear appropriate warehouse attire and Personal Protective Equipment (PPE) daily</li>
</ul><div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Material Handler 1 Contractor

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 operational leadership for aseptic processing, contamination control, environmental monitoring, cleanroom operations, microbiological quality systems, and inspection readiness across centralized manufacturing activities associated with autologous renal cell therapy products.
The Director will ensure compliance with FDA, EMA, and global GMP expectations for sterile and aseptic manufacturing, with particular emphasis on the unique risks associated with patient-specific autologous manufacturing, open manipulations, short manufacturing timelines, cryopreservation, and chain-of-identity/chain-of-custody controls.
This individual will serve as a key technical and quality leader supporting BLA readiness, process validation, commercial launch preparation, and pre-approval inspection (PLI) activities.
Key Responsibilities
Sterility Assurance &amp; Contamination Control Strategy
<ul>
<li>Define, own, and govern the enterprise contamination control strategy (CCS) for autologous cell therapy manufacturing operations.</li>
<li>Serve as an SME for sterility assurance, aseptic processing, and contamination control in cell therapy manufacturing environments.</li>
<li>Establish risk-based microbial control strategies tailored to autologous manufacturing workflows and patient-specific processing.</li>
<li>Ensure alignment of sterility assurance programs with:</li>
</ul>
<ul>
<ul>
<li>FDA aseptic processing guidance</li>
<li>EU GMP Annex 1</li>
<li>ATMP expectations</li>
<li>applicable ICH guidance</li>
</ul>
</ul>
Autologous Cell Therapy Manufacturing Support
<ul>
<li>Provide oversight of aseptic manufacturing operations involving:</li>
</ul>
<ul>
<ul>
<li>patient-derived starting materials</li>
<li>open and semi-closed manipulations</li>
<li>biosafety cabinet operations</li>
<li>cryopreservation activities</li>
<li>final product handling and fill activities</li>
</ul>
</ul>
<ul>
<li>Define sterility-assurance requirements for manufacturing strategies that minimize operator intervention and contamination risk.</li>
<li>Review and approve aseptic process workflows, interventions, and operator practices.</li>
<li>Partner with Manufacturing and QC Micro to optimize contamination control during process scale-out and technology transfer.</li>
</ul>
Environmental Monitoring &amp; Cleanroom Oversight
<ul>
<li>Support the strategy for environmental monitoring (EM) programs across GMP cleanrooms and classified processing environments.</li>
<li>Ensure robust trending and investigation of:</li>
</ul>
<ul>
<ul>
<li>viable and non-viable EM excursions</li>
<li>personnel monitoring results</li>
<li>contamination events</li>
<li>aseptic process deviations</li>
</ul>
</ul>
<ul>
<li>Establish scientifically justified alert/action levels and escalation procedures.</li>
<li>Oversee cleanroom qualification and ongoing state-of-control assessments.</li>
</ul>
Aseptic Process Simulation &amp; Validation
<ul>
<li>Lead strategy for media fills / aseptic process simulations (APS) representative of autologous manufacturing operations.</li>
<li>Ensure APS programs appropriately model:</li>
</ul>
<ul>
<ul>
<li>extended manipulations</li>
<li>worst-case interventions</li>
<li>operator variability</li>
<li>low-volume processing</li>
<li>cryogenic handling steps</li>
</ul>
</ul>
<ul>
<li>Support qualification and validation activities for:</li>
</ul>
<ul>
<ul>
<li>biosafety cabinets</li>
<li>isolators (if applicable)</li>
<li>incubators</li>
<li>cryostorage systems</li>
<li>single-use manufacturing systems</li>
<li>sterilizing filtration processes</li>
</ul>
</ul>
Chain of Identity / Chain of Custody Risk Control
<ul>
<li>Collaborate cross-functionally to ensure contamination control strategies are integrated with:</li>
</ul>
<ul>
<ul>
<li>chain-of-identity systems</li>
<li>chain-of-custody controls</li>
<li>material segregation procedures</li>
<li>patient-specific manufacturing safeguards</li>
</ul>
</ul>
<ul>
<li>Assess operational risks associated with multi-product and multi-patient processing environments.</li>
</ul>
Regulatory Inspection Readiness
<ul>
<li>Serve as the sterility assurance SME during:</li>
</ul>
<ul>
<ul>
<li>FDA inspections</li>
<li>pre-license inspections (PLI)</li>
<li>partner audits</li>
<li>regulatory agency interactions</li>
</ul>
</ul>
<ul>
<li>Support preparation of regulatory filings and responses related to sterility assurance and aseptic manufacturing controls.</li>
<li>Lead inspection readiness activities related to:</li>
</ul>
<ul>
<ul>
<li>contamination control strategy</li>
<li>APS/media fills</li>
<li>environmental monitoring</li>
<li>microbial investigations</li>
<li>aseptic operator qualification</li>
</ul>
</ul>
Investigations, CAPA &amp; Quality Systems
<ul>
<li>Provide technical leadership for microbial and contamination investigations.</li>
<li>Ensure timely, science-based root cause analysis and effective CAPA implementation.</li>
<li>Review deviations, change controls, and risk assessments impacting sterile manufacturing operations.</li>
<li>Drive continuous improvement initiatives to strengthen contamination prevention and operational robustness.</li>
</ul>
Cross-Functional Leadership
<ul>
<li>Partner closely with:</li>
</ul>
<ul>
<ul>
<li>Manufacturing Operations</li>
<li>Quality Assurance</li>
<li>QC Microbiology</li>
<li>MSAT</li>
<li>Facilities &amp; Engineering</li>
<li>Supply Chain</li>
<li>Regulatory Affairs</li>
</ul>
</ul>
<ul>
<li>Support strategic planning for commercial manufacturing readiness and network expansion.</li>
</ul>
Team Leadership
<ul>
<li>Build and lead high-performing sterility assurance and contamination control teams.</li>
<li>Develop training programs focused on:</li>
</ul>
<ul>
<ul>
<li>aseptic behaviors</li>
<li>contamination prevention</li>
<li>Annex 1 expectations</li>
<li>GMP cleanroom practices</li>
</ul>
</ul>
<ul>
<li>Foster a strong quality culture emphasizing proactive risk identification and operational discipline.</li>
</ul>
Qualifications
Education
<ul>
<li>Bachelor’s degree in Microbiology, Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.</li>
<li>Advanced degree preferred.</li>
</ul>
Experience
<ul>
<li>12+ years of experience in sterile biologics, cell therapy, or aseptic pharmaceutical manufacturing.</li>
<li>Significant experience supporting autologous cell therapy or other patient-specific manufacturing operations strongly preferred.</li>
<li>Demonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation.</li>
<li>Prior regulatory inspection experience required.</li>
</ul>
Technical Expertise
Deep expertise in:
<ul>
<li>aseptic processing</li>
<li>contamination control strategy development</li>
<li>Annex 1 implementation</li>
<li>environmental monitoring</li>
<li>cleanroom operations</li>
<li>microbial investigations</li>
<li>media fill design and execution</li>
<li>quality risk management (ICH Q9)</li>
<li>GMP manufacturing for ATMPs/cell therapies</li>
</ul>
Preferred experience with:
<ul>
<li>autologous manufacturing workflows</li>
<li>cryopreservation operations</li>
<li>biosafety cabinet operations</li>
<li>rapid sterility methods</li>
<li>single-use systems</li>
<li>decentralized manufacturing models</li>
<li>chain-of-identity / chain-of-custody systems</li>
</ul>
Leadership Competencies
<ul>
<li>Strong executive communication and inspection interaction skills</li>
<li>Ability to influence across Quality, Manufacturing, and Technical Operations</li>
<li>Strategic systems-thinking capability</li>
<li>Strong operational judgment under high-pressure manufacturing conditions</li>
<li>Ability to build a proactive contamination-control culture</li>
<li>Excellent mentoring and organizational leadership skills</li>
<li>Exhibits TRAC Leadership values</li>
</ul><div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Director of Sterility Assurance

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, qualification standards, supplier technical requirements, and ongoing performance monitoring.
This individual will serve as a key technical leader supporting BLA readiness, process validation, commercial launch preparation, and pre-license inspection (PLI) activities.
Key Responsibilities
<ul>
<li>Develop and implement strategic frameworks for raw material knowledge transfer and lifecycle management</li>
<li>Lead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturability</li>
<li>Partner with Quality Assurance and Supply Chain to define the technical elements of supplier qualification, supplier monitoring, change notification assessment, and supplier corrective action plans.</li>
<li>Establish and manage the extractable/leachables program using risk based methodologies with external partners</li>
<li>Establish and govern the cGMP visual inspection program, including defect standards, sampling approaches, training requirements, escalation criteria, and trend review.</li>
<li>Define critical material attributes and their linkage to process performance and robustness</li>
<li>Act as the subject matter expert on raw material science within CMC technical teams</li>
<li>Conduct risk assessments, supplier evaluations, and manage post-approval changes related to raw materials</li>
<li>Collaborate on regulatory submissions and health authority interactions regarding material science topics</li>
<li>&nbsp;</li>
</ul>
Investigations, CAPA &amp; Quality Systems
<ul>
<li>Ensure timely, science-based root cause analysis and effective CAPA implementation for raw material related deviations and proactive initiatives</li>
<li>Review deviations, change controls, and risk assessments impacting raw material operations, including vendor notifications</li>
<li>Drive continuous improvement initiatives to strengthen robustness of raw material program.</li>
</ul>
Cross-Functional Leadership
<ul>
<li>Partner closely with:</li>
</ul>
<ul>
<ul>
<li>Manufacturing Operations</li>
<li>Quality Assurance</li>
<li>QC Microbiology</li>
<li>MSAT</li>
<li>Facilities &amp; Engineering</li>
<li>Supply Chain</li>
<li>Regulatory Affairs</li>
</ul>
</ul>
<ul>
<li>Support strategic planning for commercial manufacturing readiness and network expansion.</li>
</ul>
Team Leadership
<ul>
<li>Build and lead high-performing raw material team focused on risk mitigation strategies</li>
<li>Develop training programs focused on:</li>
</ul>
<ul>
<ul>
<li>Material Qualification</li>
<li>In-coming receipt, inspection and testing</li>
<li>cGMP cleanroom practices</li>
</ul>
</ul>
<ul>
<li>Foster a strong quality culture emphasizing proactive risk identification and operational discipline.</li>
</ul>
Qualifications
Education
<ul>
<li>Bachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.</li>
<li>Advanced degree preferred.</li>
</ul>
Experience
<ul>
<li>10+ years of experience in biologics or cell and gene therapy (CGT),</li>
<li>Significant experience supporting autologous cell therapy, CGT or other patient-specific manufacturing operations strongly preferred.</li>
<li>Demonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation.</li>
</ul>
<ul>
<li>Deep knowledge of CMC processes for biologics, CGT or Cell Therapy platforms, including technology transfer and lifecycle management</li>
<li>Proven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturing</li>
<li>Strong organizational, problem-solving, and communication skills with the ability to influence decisions across teams</li>
<li>Experience with commercial product lifecycle management including post-approval changes and supplier updates</li>
<li>Comprehensive understanding of cGMP requirements and regulatory expectations related to raw materials</li>
</ul>
Leadership Competencies
<ul>
<li>Strong executive communication and inspection interaction skills</li>
<li>Ability to influence across Quality, Manufacturing, and Technical Operations</li>
<li>Strategic systems-thinking capability</li>
<li>Strong operational judgment under high-pressure manufacturing conditions</li>
<li>Ability to build a proactive culture around continuous improvement</li>
<li>May lead a team of engineers/scientists</li>
<li>Excellent mentoring and organizational leadership skills</li>
<li>Exhibit TRAC Leadership values</li>
</ul><div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Associate Director, Raw Materials MSAT

The Senior Manager, HR Systems &amp; Operations leads the day-to-day administration and continuous improvement of ProKidney’s HR systems and core HR operations. Reporting to the Senior Director, Total Rewards and HR Operations, this role ensures that HR technology, data, and processes supporting payroll, benefits, talent management, compliance, and the employee lifecycle are accurate, efficient, secure, and reliable.
This hands-on role manages HRIS service delivery, operational workflows, reporting, and data integrity while leading a team focused on timely, high-quality execution. The Senior Manager partners closely with HR, IT, Finance, Payroll, Legal, and external vendors to resolve issues, streamline processes, strengthen controls, and deliver scalable HR operations, escalating strategic decisions to the Senior Director as appropriate.
Essential Duties &amp; Responsibilities: 
HRIS Platform Management and Data Operations
<ul>
<li>Manage day-to-day HR systems administration: Configure systems, troubleshoot issues, set up new users, deliver user training and support, and manage access and permissions; coordinate technical maintenance performed by designated administrator users.</li>
<li>Administer the HR systems portfolio: Provide operational support for Paylocity and successor HRIS platforms, Traliant, HireRight, Motivosity, TeamOhana, Greenhouse, and other assigned HR technologies.</li>
<li>Implement and maintain system integrations: Coordinate integration requirements, testing, implementation, monitoring, troubleshooting, and data-flow validation between HR systems and business applications.</li>
<li>Ensure data integrity and accuracy: Reconcile information across HRIS, payroll, benefits, and Finance systems; conduct recurring data audits, correct discrepancies, and document findings and remediation.</li>
<li>Maintain HR systems access controls: Manage user access, approval workflows, and security protocols; coordinate with IT and vendors on access issues, updates, and escalations.</li>
<li>Manage SharePoint and the HR intranet: Maintain site organization, content, permissions, and employee-facing HR resources; support HR users with updates, navigation, and troubleshooting as needed.</li>
<li>Monitor system performance: Track recurring issues, communicate system status, and work with internal partners and vendors to resolve operational problems.</li>
</ul>
HR Operations Process Management
<ul>
<li>Manage new hire onboarding: Complete and oversee new hire data entry, Form I-9 verification, welcome communications, and coordination with HR, hiring managers, IT, Finance, Payroll, and other stakeholders to ensure a timely and consistent onboarding experience.</li>
<li>Manage offboarding: Coordinate employee separations, including HRIS transactions, access and equipment notifications, final documentation, benefits and payroll coordination, and completion tracking across stakeholders.</li>
<li>Manage immigration and visa administration: Coordinate immigration and work authorization processes with employees, managers, external counsel, and vendors; track documentation, case milestones, renewals, and required deadlines.</li>
<li>Manage relocation administration: Coordinate employee relocations, vendor activity, approvals, communications, reimbursements, and supporting documentation in accordance with company policy.</li>
<li>Manage the Employee Action Form process: Review and process EAFs, enter employee changes in Paylocity and successor systems, complete day-to-day employee data updates, validate approvals, and confirm accurate downstream processing.</li>
<li>Administer required employee training: Manage anti-harassment and insider trading training for new hires, contractors, and consultants, as well as ongoing and annual training for the broader workforce; maintain assignments, completion records, reminders, and escalation reporting.</li>
<li>Maintain operational procedures: Document and communicate HR operations processes to promote consistent, compliant, and timely execution.</li>
<li>Drive operational improvements: Identify opportunities to streamline workflows, reduce manual work, and improve accuracy; implement practical process changes and measure results.</li>
<li>Manage escalations and employee requests: Research and resolve inquiries related to HR systems, policies, employee records, and HR processes; identify recurring issues that require correction or clarification.</li>
<li>Support benefits administration: Coordinate enrollment activities, benefits transitions for new and departing employees, reconciliations, communications, and issue resolution with benefit partners.</li>
</ul>
HR Data, Analytics, and Reporting
<ul>
<li>Collect, analyze, and report HR metrics: Produce recurring and ad hoc reporting on headcount, hiring, turnover, payroll, benefits, compensation, and other assigned workforce measures.</li>
<li>Generate reports and dashboards: Build and maintain clear, accurate dashboards and summaries that provide actionable insights to support operational and business decision-making.</li>
<li>Conduct regular data audits: Review HR data for completeness, consistency, and accuracy; investigate discrepancies, implement corrections, and document audit results.</li>
<li>Maintain reporting standards: Apply consistent data definitions, reporting schedules, and quality checks so HR leadership and business partners can rely on the information provided.</li>
<li>Support ad hoc analysis: Respond to data requests from HR leadership, Finance, Legal, and other stakeholders with timely and accurate findings.</li>
<li>Validate compensation and benefits data: Partner with Total Rewards, Finance, Payroll, and benefits teams to confirm that compensation, bonus, equity, benefits, and deduction data is current and accurately reflected in HR systems.</li>
</ul>
Policies, Compliance, and Regulatory Administration
<ul>
<li>Manage the HR compliance dashboard: Maintain compliance requirements, owners, due dates, completion status, and supporting documentation; follow up on open items and escalate risks or missed deadlines.</li>
<li>Monitor employment compliance requirements: Track applicable federal, state, and local HR regulations and coordinate operational updates to processes, systems, records, and communications.</li>
<li>Manage labor law posters: Maintain current federal, state, and local workplace postings for applicable work locations and communicate updates to relevant stakeholders.</li>
<li>Coordinate audits and required submissions: Compile, validate, and submit HR data and documentation for internal and external audits and surveys, including IT SOX controls and EEO-1 reporting, in partnership with HR, IT, Finance, and Legal.</li>
<li>Maintain compliance records: Organize supporting documentation, evidence of completion, and audit trails to demonstrate timely and accurate fulfillment of HR compliance obligations.</li>
</ul>
Cross-Functional Coordination
<ul>
<li>Partner with Finance and Payroll: Coordinate on payroll submissions, compensation data integrity, benefits spending, and financial reconciliation; respond to data requests and ensure alignment on HRIS data across systems.</li>
<li>Collaborate with Legal: Support Legal with employment documentation, policy compliance reviews, and separation procedures; escalate compliance questions.</li>
<li>Represent HR Operations: Communicate HR operations capabilities, timelines, and constraints to HR leadership and other departments; escalate issues that require senior leadership attention.</li>
</ul>
&nbsp;
Qualifications:
<ul>
<li>Education/Training: Bachelor’s degree in Human Resources, Business Administration, or related field; plus 8+ years of progressive HR operations experience demonstrating Senior Manager-level impact and scope.</li>
<li>Experience:
<ul>
<li>HRIS Platform Expertise: 8+ years managing HRIS platforms (UKG, ADP, Workday, or similar); strong hands-on experience with user administration, data management, reporting, and system troubleshooting.</li>
<li>HR Operations Management: 8+ years managing HR operations functions, including process execution, compliance, and team coordination; demonstrated ability to run operational functions at scale.</li>
<li>Process Management: Experience designing, implementing, and optimizing HR operations processes; ability to measure effectiveness and drive continuous improvement.</li>
<li>Payroll and Benefits Administration: Solid working knowledge of payroll coordination, benefits administration, and compensation data management; experience ensuring accuracy and timeliness.</li>
<li>Data and Reporting: Ability to create accurate HR reports, dashboards, and analytics; comfort with data analysis and interpreting trends; experience with HR reporting tools or data systems.</li>
<li>Demonstrated experience managing and leading HR operations or similar teams; ability to set clear expectations, provide feedback, and hold team members accountable.</li>
<li>Experience working in a matrixed or cross-functional environment; ability to coordinate effectively across multiple stakeholders and priorities.</li>
</ul>
</li>
</ul>
<ul>
<li>Knowledge and Skills:
<ul>
<li>Strong working knowledge of HR operations, benefits administration, payroll coordination, and employment law.</li>
<li>Technical proficiency: HRIS platforms, data systems, and reporting tools; comfort with Excel and ability to work with data.</li>
<li>Problem-solving skills: Ability to diagnose operational issues, identify root causes, and implement solutions.</li>
<li>Communication skills: Clear written and verbal communication; ability to explain complex HR/systems topics to non-specialists.</li>
<li>Organizational and project management skills: Ability to manage multiple priorities, track details, and meet deadlines.</li>
<li>Attention to detail and commitment to accuracy: HR operations requires precision; data errors can cascade through payroll and benefits.</li>
<li>Ability to work collaboratively across functions; build relationships and influence outcomes through partnership.</li>
<li>Discretion and confidentiality: Handle sensitive employee and compensation information appropriately.</li>
</ul>
</li>
</ul>
<ul>
<li>Key Success Metrics: Success in this role will be measured across five areas:
<ul>
<li>Systems and Data: HRIS accuracy, audit results, reporting quality, and data security;</li>
<li>Operational Delivery: Timely onboarding, offboarding, payroll submissions, benefits administration, and employee support</li>
<li>Compliance and Controls: Completion of required activities, documentation, and regulatory deadlines</li>
<li>Process Improvement: Measurable reductions in manual work, processing time, and errors; and</li>
<li>Team and Service Performance: Reliable delivery, quality, responsiveness, and stakeholder satisfaction.</li>
</ul>
</li>
</ul>
&nbsp;<div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Sr Manager, HR Systems & Operations

Lead Facilities Technician

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 late stage and commercial CMC regulatory submissions, coordinating the planning and on-time completion of CMC activities through BLA filing, PLI and approval. The successful candidate must possess a technical understanding of the inter-disciplinary nature of cell therapy development, demonstrated with previous experience. The position requires timeline and deliverable management with close collaboration with Operation, Quality and Regulatory, and requires collaboration with program management to provide sufficient details into the Integrated Project Plan (IPP).
The position reports to the Vice President, Technical Operations Strategy, with a dotted line to Program Management (PMO).
Key Responsibilities:
<ul>
<li>In support of the CMC strategy, translate the strategy into project plans with defined deliverables and deadlines, and drive the cross-functional teams and manage inter-dependencies across Technical Operations functions to complete them.</li>
<li>Develop, drive and maintain detailed CMC Plan and Major Milestones activities across Technical Operations, plan and track content draft, review and delivery dates against identified timelines, proactively identify and prioritize program risks and develop and monitor risk mitigation-contingency plans</li>
<li>Facilitating CMC GAP Assessment, Risk Analysis, strategy discussions and other meetings and operational mechanisms to drive cross-functional decision making, and successful execution of program plans for facilitating CMC Planning activities.</li>
<li>Lead data-driven decision-making to facilitate timely, objective recommendations for continuation, acceleration, re-prioritization, redesign or termination of projects, along with necessary change management recommendations.</li>
<li>Provide periodic status reports and coordinate documentation of project deliverables and escalate timeline slips, emerging risks and unresolved dependencies, with the schedule and inspection consequence stated.</li>
<li>Escalate timeline slips, emerging risks and unresolved dependencies promptly, with the schedule and filing/inspection consequence stated.</li>
<li>Serve as the primary CMC point of contact for internal stakeholders, representing CMC at project team meetings.</li>
<li>Lead and prioritize the project managers supporting CMC projects.</li>
<li>Own the standards, templates and cadence for CMC Planning, so CMC plans, milestones and risk records are produced and maintained consistently across the group.</li>
<li>Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of sight to key issues and accomplishments.</li>
</ul>
Secondary Responsibilities
<ul>
<li>Collaborate with Operations, QA, RA and other members of the CMC team to plan, sequence and track technology transfer, comparability, process scale-up and validation activities and their deliverables, in support of routine/non-routine development and CMC cGMP activities</li>
<li>Contribute to the development of CMC Planning within the context of an Integrated Development plan (IDP), to identify risks and potential risk mitigation strategy with the overall IDP. Identify risks within the CMC strategic development plan.</li>
<li>Dotted line to the VP, Program Leadership &amp; Management (PMO): report on a defined cadence, providing sufficient information on the CMC plan to feed the Integrated Project Plan (IPP).</li>
</ul>
Qualifications:
<ul>
<li>Education/Training:
<ul>
<li>Bachelor's degree in sciences or related field. Advanced degree (MS, PhD) preferred.</li>
</ul>
</li>
<li>Experience:
<ul>
<li>12+ years of relevant biopharmaceutical industry experience with 6+ years of cell therapy experience</li>
<li>Prior background in CMC project management at a biotech/pharma company focused on biologics/cell &amp; gene therapy.</li>
<li>Experience leading project managers or a project management team.</li>
</ul>
</li>
<li>Skills/Abilities:
<ul>
<li>Must be a “hands-on” and active contributor in all aspects</li>
<li>Must have sufficient CMC depth to identify dependencies, risks and gaps across manufacturing, quality, analytical and regulatory activities working with SME’s.</li>
<li>Must have a proven track record of effective collaboration with cross functional CMC teams.</li>
<li>Must have demonstrated ability to multi-task across product pipelines and support short and long-term corporate goals.</li>
</ul>
</li>
</ul>
Must have high ethical standards and be compliance focused.<div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Director, CMC Project Management

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 compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations.
&nbsp;
This role is an onsite position requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.
&nbsp;
Essential Duties &amp; Responsibilities
<ul>
<li>Provide QA review of moderate‑complexity manufacturing operations in classified environments.</li>
<li>Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.</li>
<li>Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.</li>
<li>Review manufacturing records, environmental monitoring data, and related documentation.</li>
<li>Perform and verify line clearance activities for assigned processes.</li>
<li>Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required.</li>
<li>Support and contribute to deviation investigations, CAPAS, and remediation activities.</li>
<li>Review and approve facility alarms, work orders, and return‑to‑service documentation.</li>
<li>Participate in internal audits, inspections, and cross‑functional quality initiatives.</li>
<li>Follow all gowning, safety, and cleanroom behavior requirements.</li>
</ul>
&nbsp;
Education &amp; Experience Requirements
<ul>
<li>Bachelor’s degree in an applied science field or equivalent experience.</li>
<li>5 years of QA experience in a GMP‑regulated manufacturing or quality environment</li>
<li>Aseptic manufacturing experience preferred.</li>
</ul>
Knowledge &amp; Skills
<ul>
<li>Solid professional knowledge of cGMP regulations and quality systems.</li>
<li>Ability to apply judgement to moderately complex quality issues.</li>
<li>Strong documentation, analytical and problem-solving skills.</li>
<li>Effective cross-functional communication and collaboration.</li>
<li>Ability to manage multiple priorities with limited supervision.</li>
</ul>
&nbsp;
Working Conditions
<ul>
<li>This position requires full‑time onsite work in a GMP manufacturing environment.</li>
<li>Not eligible for remote or hybrid work.</li>
<li>Requires full gowning and extended time in cleanroom and classified areas.</li>
<li>Ability to stand for extended periods and perform physical tasks as required.</li>
</ul>
&nbsp;<div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Quality Assurance Specialist 3, Floor Support

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 documentation — including System Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Test Scripts, and RTMs — in accordance with GAMP 5, 21 CFR Part 11, and FDA's Computer Software Assurance guidance.
Responsibilities
<ul>
<li>Provide leadership and direction to Validation team members, driving performance and value creation aligned with site operational and strategic goals</li>
<li>Ensure adequate resourcing (capacity and capability) to accomplish site objectives; identify and recommend solutions to alleviate constraints in partnership with the Director of Validation</li>
<li>Regularly interacts with cross-functional department leaders on multi-department projects and challenges; supports change initiatives led by senior leadership</li>
<li>Actively contribute to and continuously improve the culture of the Validation team and the broader site</li>
<li>Supports Validation representation during GMP and other regulatory agency inspections (FDA, CDC, OSHA, etc.) under the direction of the Director of Validation</li>
<li>Identify areas to improve project delivery efficiency and reduce operational costs; bring forward recommendations and support implementation of approved investment strategies</li>
<li>Hands-on troubleshooting and problem solving at the Gemba in support of Validation team members and operations</li>
<li>Develop and lead small to medium-sized continuous improvement projects; remain actively involved in projects led by staff members</li>
<li>Effectively delegate work and build confidence and competence within direct reports through coaching and mentorship</li>
<li>Drive engagement in the technical and personal development of Validation team members</li>
<li>Develop strong cross-functional relationships with partners (QA, Manufacturing, Engineering, etc.) and model collaborative behaviors for all team members</li>
<li>Provide effective cross-functional leadership to support delivery of site objectives in alignment with the site validation strategy</li>
</ul>
Qualifications
<ul>
<li>Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering</li>
<li>A minimum of 7 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role</li>
<li>Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)</li>
<li>Strong understanding of Validation Lifecycle (GAMP 5) principles</li>
<li>Experience with calibration and maintenance management software</li>
<li>Knowledge of electronic document management systems</li>
<li>Experience with data integrity practices and compliance</li>
<li>Strong technical writing skills for qualification documents, SOPs, and work instructions</li>
<li>Ability to manage multiple projects simultaneously with minimal supervision</li>
<li>Detail-oriented with excellent verbal and written communication abilities</li>
<li>Ability to adapt to changing priorities in a deadline-oriented environment</li>
<li>Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.</li>
<li>Knowledge of pharmaceutical equipment, such as centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.</li>
<li>Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.</li>
<li>Experience in writing computer system test scripts, validation protocols and summary reports</li>
</ul>
&nbsp;<div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Senior Manager, Validation

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 Practices (cGMP) while assisting senior QA staff with routine daily activities. The role requires full gowning, continuous on-floor presence, and a strong focus on accuracy, documentation, and adherence to established procedures to support manufacturing operations.
&nbsp;
This role is an onsite position requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work. The shift is Monday - Friday 10am-630pm with over time and flexibility needed based on the needs of the business. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.&nbsp;
&nbsp;
Essential Duties &amp; Responsibilities
<ul>
<li>Support senior QA personnel during real‑time manufacturing and facility activities in classified environments.</li>
<li>Maintain continuous on‑floor presence to support compliance and production activities.</li>
<li>Assist with basic in‑process batch record reviews by performing completeness and accuracy checks under supervision.</li>
<li>Review routine documentation such as logbooks, equipment use records, and cleaning logs for completeness and adherence to SOPs.</li>
<li>Assist with routine line clearance activities following established checklists and procedures.</li>
<li>Recognize and report quality observations or documentation discrepancies to senior QA staff.</li>
<li>Support deviation documentation, investigations, and remediation activities under supervision.</li>
<li>Participate in required GMP, safety, and compliance training programs.</li>
<li>Follow all gowning, safety, and cleanroom behavior requirements.</li>
</ul>
&nbsp;
Education &amp; Experience Requirements
<ul>
<li>Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field; or equivalent combination of education and experience.</li>
<li>0-1 year of experience in a GMP‑regulated, manufacturing, laboratory, or quality environment</li>
<li>Exposure to aseptic manufacturing preferred but not required.</li>
</ul>
&nbsp;
Knowledge &amp; Skills
<ul>
<li>Foundational understanding of GMP concepts or willingness to learn.</li>
<li>Strong attention to detail and commitment to documentation accuracy.</li>
<li>Basic organizational, communication, and collaboration skills.</li>
<li>Ability to perform physical tasks and work in gowning-required environments.</li>
</ul>
&nbsp;
Working Conditions
<ul>
<li>This position requires full‑time onsite work in a GMP manufacturing environment.</li>
<li>Not eligible for remote or hybrid work.</li>
<li>Requires full gowning and extended time in cleanroom and classified areas.</li>
</ul><div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

Quality Assurance Specialist 1 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 members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.
Responsibilities:
<ul>
<li>Program and validate tables, listings, figures, and derived datasets using SAS.</li>
<li>Develop SDTM and ADaM specs, datasets, and supporting documentation.</li>
<li>Prepare and review mapping specifications, annotated case report forms (aCRF), define, SDRG, ADRG and other files needed in the submission.</li>
<li>Perform quality control and validation activities for all programming deliverables.</li>
<li>Collaborate with study team members to identify, investigate, and resolve data and output issues.</li>
<li>Review study documents and provide input to improve programming quality, efficiency, and consistency.</li>
<li>Maintain complete, accurate, and audit-/inspection-ready programming documentation.</li>
<li>Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.</li>
<li>Other as assigned.</li>
</ul>
&nbsp;Qualifications:
<ul>
<li>Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.</li>
<li>Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.</li>
<li>Phase 3 and regulatory submission experience preferred.</li>
<li>Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.</li>
<li>Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.</li>
<li>High attention to detail, with strong analytical, problem-solving, and communication skills.</li>
<li>Ability to work independently and manage multiple priorities in a deadline-driven environment.</li>
</ul>
&nbsp;
&nbsp;<div class="content-conclusion">ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.</div>

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