ProKidney Corp.

• Lead validation projects, including the planning, execution, and documentation of computer system validation deliverables. • Lead qualification, validation, and periodic review activities for laboratory and manufacturing instrument software and systems. • Ensure continued GxP compliance of QC laboratory computer systems and software. • Coordinate with IT Operations team to ensure data backup and disaster recovery strategies for critical laboratory systems are setup. • Collaborate with QA teams to ensure alignment of priorities and delivery of outcomes (policies, procedures and documents). • Provide guidance and oversight to ensure computerized systems are deployed and maintained following the full system lifecycle (SDLC), IT change control, and applicable SOPs. • Review and approve validation deliverables authored by internal teams and external vendors. • Manage multiple validation and compliance projects simultaneously, balancing priorities across manufacturing, clinical, and corporate systems. • Ensure audit and inspection readiness by maintaining documentation quality, traceability, and regulatory alignment. • Lead the creation, revision, and implementation of IT governance SOPs and quality documentation, ensuring alignment with FDA Computer Software Assurance (CSA) principles and risk-based validation strategies. • Conduct audits of IT systems, vendors, and validation documentation. • Partner with QA and business stakeholders to maintain validated system compliance through release management, change control, incident management, CAPA, periodic reviews, and audit trail reviews. • Conduct impact and risk assessments for changes affecting validated systems and ensure appropriate mitigation actions. • Maintain the inventory of all GxP computerized systems, ensuring re-qualification/revalidation schedules are current and properly documented. • Perform system risk assessments to determine GxP classification and validation requirements. • Manage vendor qualification activities, including the distribution and evaluation of IT vendor questionnaires and supporting audits or assessments. • Be onsite to provide vendor oversight, when needed.

• Program and validate tables, listings, figures, and derived datasets using SAS. • Develop SDTM and ADaM datasets and supporting documentation. • Prepare and review mapping specifications and annotated case report forms (CRFs). • Perform quality control and validation activities for programming deliverables. • Collaborate with study team members to identify, investigate, and resolve data and output issues. • Review study documents and provide input to improve programming quality, efficiency, and consistency. • Maintain complete, accurate, and audit-/inspection-ready programming documentation. • Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

• Develop and execute innovative sourcing strategies, utilizing market intelligence to meet complex, high-priority hiring demands. • Serve as a strategic partner to business unit leaders, translating complex business needs into actionable hiring plans and workforce strategies. • Partner extensively with hiring managers, HR Business Partners, and functional leaders as a strategic talent advisor providing market and talent insights • Ensure a smooth and professional candidate journey by managing communications, resolving issues, and providing timely updates throughout the hiring process. • Collaborate with the business and HR Business Partners to continue to embed structured, candidate-centered selection practices that ensure consistent, high-quality hiring decisions and positive experience • Schedule interviews using Greenhouse Applicant Tracking system, manage candidate on site visits and ensure all necessary details are communicated to candidates and interviews in a timely manner. Work with Corporate Traveler to coordinate candidate travel and logistics. Maintain candidate records in Greenhouse, ensuring accuracy, confidentiality and compliance. • Collaborate with Total Rewards Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. • Act as an SME for Greenhouse Applicant Tracking System, troubleshooting issues, managing templates, and escalating system concerns as needed. • Participate in projects related to TA processes, systems/tools, procedures, and compliance. • Participate and assist with ProKidney’s employment branding initiatives and university recruiting efforts.

• Provide support to develop and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the focus on manufacturing and quality domains. • Analyze business needs and requirements for data and analytics to support regulatory filings. • Identify, classify, and map data sources. • Build data lineage diagram from data source to analytics ready datasets • Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases. • Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing. • Develop data governance standards to comply with company and industry best practices. • Lead development of key project documents such as user requirements, design specifications, and configuration specifications. • Lead development of test scenarios and scripts in partnership with business, technical, and validation team members. • Lead test execution according to test protocols. • Provide support for development of standard operating procedures and other documentation required to go-Live. • Monitor execution of testing and relay results to technical team to address issues. • Provide support for training business teams for Go-Live • Development of training materials as needed • Provide regular updates to project team

Position Summary: Provide support to develop and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the focus on manufacturing and quality domains. Essential Duties & Responsibilities: - Analyze business needs and requirements for data and analytics to support regulatory filings. - Identify, classify, and map data sources. - Build data lineage diagram from data source to analytics ready datasets - Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases. - Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing. - Develop data governance standards to comply with company and industry best practices. - Lead development of key project documents such as user requirements, design specifications, and configuration specifications. - Lead development of test scenarios and scripts in partnership with business, technical, and validation team members. - Lead test execution according to test protocols. - Provide support for development of standard operating procedures and other documentation required to go-Live. - Monitor execution of testing and relay results to technical team to address issues. - Provide support for training business teams for Go-Live - Development of training materials as needed - Provide regular updates to project team Qualifications: - Education/Training: Bachelor’s Degree. - Experience: - Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects - Experience working in Biotech/Pharma (Regulated Industry) - Experience with developing requirements, design, and testing documents. - Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment. - Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools. - Experience with design and development and usage of data repository and analytics platforms - Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments. - Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation) - Experience with system administration responsibilities - Experience with helping lead data analysis and engineering projects - Ability to work under tight timelines - Ability to communicate and work across teams in collaborative manner - Ability to work independently with minimal supervision - Knowledge: - GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting - Understanding of data modeling tools - Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries) - Experience with database (SQL) and ETL development - Experience with cloud environments (AWS, Azure) - Experience with usage of process analytic software is a plus (Aveva, Seeq). - Skills: - System Support/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation. - Certifications/Licenses: None 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.

• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, and amendments. • Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions. • Maintain and track regulatory submission timelines and deliverables. • Support responses to health authority information requests related to CMC topics. • Review and assess change controls to determine potential regulatory impact and filing requirements. • Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies. • Help ensure documentation and submissions meet current regulatory standards and internal quality requirements. • Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs. • Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff. • Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities. • Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation.

• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials. • Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents. • Provide scientific input for trial endpoints, patient populations, and statistical analyses. • Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements. • Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review. • Review and interpret clinical trial data, ensuring consistency and alignment with study objectives. • Address protocol-related questions from investigators and site staff. • Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings. • Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards. • Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness. • Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications. • Partner with cross functional team members to develop and execute clinical development strategies. • Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.