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 Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.This position offers an excellent opportunity to grow in regulatory affairs within an innovative, fast-paced biotechnology environment focused on advanced therapies. Responsibilities:Regulatory Documentation &amp; Submissions:• &nbsp; &nbsp;Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, and amendments.• &nbsp; &nbsp;Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions.• &nbsp; &nbsp;Maintain and track regulatory submission timelines and deliverables.• &nbsp; &nbsp;Support responses to health authority information requests related to CMC topics.Change Control &amp; Compliance Support:• &nbsp; &nbsp;Review and assess change controls to determine potential regulatory impact and filing requirements.• &nbsp; &nbsp;Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies.• &nbsp; &nbsp;Help ensure documentation and submissions meet current regulatory standards and internal quality requirements.Cross-functional Collaboration:• &nbsp; &nbsp;Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs.• &nbsp; &nbsp;Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff.Process and Documentation Support:• &nbsp; &nbsp;Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities.• &nbsp; &nbsp;Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation. Qualifications:• &nbsp; &nbsp;Bachelor’s or master’s degree in a scientific or engineering discipline (e.g., biology, chemistry, biochemistry, pharmaceutical sciences).•&nbsp; &nbsp; 5+ years of experience in Regulatory Affairs or related experience in Manufacturing, QA, or QC in a biotech/pharmaceutical environment.• &nbsp; &nbsp;Exposure to CMC regulatory filings (INDs, CTAs, or amendments) preferred.• &nbsp; &nbsp;Experience in cell or gene therapy is a plus, but not required.• &nbsp; &nbsp;Understanding of the drug development process and the role of CMC in regulatory submissions.• &nbsp; &nbsp;Familiarity with ICH guidelines and US/global regulatory requirements.• &nbsp; &nbsp;Strong organizational and communication skills.• &nbsp; &nbsp;Detail-oriented with a focus on quality and accuracy.• &nbsp; &nbsp;Ability to manage multiple tasks and timelines in a dynamic environment.• &nbsp; &nbsp;Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and document management systems.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.

Regulatory Manager Contractor - CMC

Position Summary:&nbsp; &nbsp;We are seeking a highly skilled and motivated Contract Scientist – Translational Biology to support mechanistic hypothesis testing and sample generation for rilparencel, our autologous kidney cell therapy currently being evaluated in a Phase 3 clinical study, as well as next-generation cell therapy programs. This role will focus on primary human tissue/cell culture models (BSL-2) and the execution of multi-condition studies that generate high-quality samples for downstream molecular and NGS-based readouts. In partnership with the Translational Biology team, this scientist will contribute to experimental design and method development for workflows involving small human biopsy-derived samples, with an emphasis on reproducible execution, rigorous sample tracking, and clear communication of results. &nbsp; Essential Duties &amp; Responsibilities:&nbsp; Primary Human Tissue Culture (BSL-2) &amp; Model Execution&nbsp; Establish,&nbsp;maintain, and troubleshoot primary human&nbsp;kidney&nbsp;tissue/cell cultures using strict aseptic&nbsp;technique&nbsp;and contamination prevention.&nbsp; Experimental Design &amp; Method Development&nbsp;&nbsp; Develop&nbsp;and execute&nbsp;experimental plans with&nbsp;the translational team&nbsp;to test mechanistic hypotheses in vitro (e.g., media perturbations, multi-factor time courses), including&nbsp;appropriate controls&nbsp;and&nbsp;replicates.&nbsp; Contribute&nbsp;to method development/optimization for primary tissue workflows (e.g., tissue handling, digestion/single-cell prep where applicable, culture conditions, sampling strategy, preservation), documenting protocol iterations and outcomes.&nbsp; Execute complex study layouts&nbsp;with many&nbsp;conditions,&nbsp;timepoints,&nbsp;replicates,&nbsp;etc&nbsp;when&nbsp;required.&nbsp; Sample Processing &amp; Molecular Assays&nbsp; Harvest tissue/cells and perform RNA/DNA/protein/metabolite&nbsp;extraction, quantification, and basic QC (e.g., yield, purity; integrity checks where applicable).&nbsp; Run and troubleshoot core&nbsp;molecular&nbsp;assays, such as RT-qPCR, ELISA, Western blot, and/or reporter assays (e.g., luciferase), including control&nbsp;selection.&nbsp; Prepare assay- and omics-ready sample sets with complete metadata for internal use and/or external partners,&nbsp;as needed.&nbsp; NGS Library Preparation &amp; Omics Support&nbsp; Perform NGS library preparation for approaches such as RNA-seq, ATAC-seq, and CITE-seq (bulk and/or&nbsp;10x&nbsp;single-cell), including essential QC steps (quantification, sizing where applicable, yield assessment).&nbsp; Support handoff of libraries/samples to sequencing vendor pipelines,&nbsp;maintaining&nbsp;traceability of sample IDs, library indices, and processing conditions.&nbsp; Documentation &amp; Communication&nbsp; Maintain high-quality experiment documentation&nbsp;(ELN)&nbsp;and&nbsp;accurate&nbsp;sample inventories&nbsp;(LIMS).&nbsp; Participate in&nbsp;interpretation&nbsp;translational data&nbsp;to uncover key insights for cell therapy&nbsp;mechanism of action elucidation.&nbsp; Communicate findings effectively across cross-functional teams, including research, process&nbsp;&amp; analytical&nbsp;development, and clinical translation groups.&nbsp; Contribute to regulatory filings, scientific publications, and presentations at key&nbsp;industry&nbsp;and academic conferences.&nbsp; &nbsp;Qualifications:&nbsp; Education/Training&nbsp; M.S. or Ph.D. in Cell Biology, Molecular Biology, Immunology, Bioengineering, or related&nbsp;field.&nbsp;&nbsp; Required Experience &amp; Skills&nbsp; Demonstrated hands-on experience with primary human tissue/cell culture and comfort working with human-derived materials in a BSL-2 environment.&nbsp; Experience executing multi-condition in vitro experiments with strong attention to detail and sample tracking.&nbsp; Experience with RNA/DNA/protein extraction and basic QC/quantification.&nbsp; Experience with at least two of: qPCR/RT-qPCR, ELISA, Western blot, reporter assays.&nbsp; Hands-on experience with NGS library preparation for one or more of: RNA-seq, ATAC-seq, CITE-seq (bulk and/or single-cell).&nbsp; Able to work effectively in a fast-moving R&amp;D environment with multiple parallel experiments and time-sensitive sample processing needs.&nbsp; Preferred&nbsp; Flow cytometry and/or FACS experience (sample prep, staining,&nbsp;acquisition&nbsp;and/or sorting workflows).&nbsp; Familiarity with common bioinformatics/QC concepts and tools used in sequencing workflows;&nbsp;familiarity&nbsp;with at least one scripting language (Python and/or R).&nbsp; Skills:&nbsp;&nbsp; Ability to work in a fast-paced environment and collaborate across disciplines&nbsp; Strong team&nbsp;player&nbsp; Goal-oriented mindset&nbsp; Ability to focus efforts &amp; complete deliverables&nbsp;on-time&nbsp; Certifications/Licenses:&nbsp;Licenses / Certification welcome&nbsp; &nbsp;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.

Scientist Contractor- Translational Biology

Position Summary:The Senior Director, Supply Chain Operations is a strategic, hands-on leader responsible for designing and executing an integrated, end-to-end supply chain operating model across planning, manufacturing scheduling, warehousing, logistics, and the external partner network. This role leads S&amp;OP, inventory strategy, and supply network optimization to deliver service excellence, cost discipline, speed, and operational resilience. As a critical enabler of patient access, this leader ensures a reliable, compliant, and patient-centered supply network — making certain therapies are available when and where patients need them. Responsibilities Strategy &amp; Leadership Develop and operationalize a multi‑year supply chain operations strategy aligned to enterprise objectives and commercial growth plans. Build and lead a high‑performing team spanning planning, scheduling, warehousing, logistics, and network operations. Establish and cascade KPIs (service, cost, agility, inventory, plan accuracy). Own the supply chain operations budget. Planning, S&amp;OP, and Scheduling Lead the enterprise S&amp;OP process integrating demand, supply, capacity, and financial plans. Oversee master production scheduling (MPS), materials planning (MRP). Standardize planning and scheduling processes. Inventory, Warehousing, Logistics &amp; Distribution Set enterprise inventory policies. Lead internal warehousing and 3PL operations. Govern international logistics, customs &amp; trade compliance. Ensure product availability and on-time distribution to support uninterrupted patient treatment. Partner cross-functionally (Commercial, Patient Services, Clinical, Quality) to proactively mitigate supply disruptions impacting patients. External Network &amp; Partner Management Manage strategic relationships with CMOs, suppliers, and logistics partners. Align systems and processes with external partners. Risk, Quality &amp; Compliance Assess supply, capacity, quality, and logistics risks and implement mitigation strategies to prevent disruptions to patient access and care continuity. Ensure adherence to regulatory and quality standards. Technology, Data &amp; Analytics Own the supply chain technology roadmap. Drive data governance and real-time reporting. People &amp; Culture Recruit, develop, and retain diverse talent. Champion safety, quality, and a patient-first mindset across the supply chain organization. This embeds patient experience into leadership expectations. Qualifications: Bachelor’s degree required; Master’s degree or MBA preferred. 12–15+ years in end‑to‑end supply chain operations. Proven track record leading global or outsourced networks. Deep expertise in S&amp;OP, inventory, MPS/MRP, logistics, and compliance. Strong understanding of ERP (SAP) and planning systems. Strategic thinking, analytics, communication, negotiation. Committed to Operational Excellence by exemplifying our Leadership Principles – Transparency, Respect, Accountability, and Collaboration. Certifications/Licenses: APICS/ASCM (CPIM/CSCP) or Lean Six Sigma preferred. 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.

Senior Director, Supply Chain

&nbsp; Position summary The Quality Assurance Specialist III supports Quality oversight of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment. This role ensures compliance with cGMP, regulatory expectations, internal quality standards, and industry best practices. The Specialist serves as a key QA liaison to both labs, providing elevated level review, technical assessment, issue resolution, and continuous improvement support for testing activities that ensure product quality, patient safety, and data integrity. Primary Responsibilities:&nbsp; &nbsp; &nbsp; Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories to&nbsp;ensure full compliance with cGMP, regulatory expectations, and internal quality standards. Review and approve laboratory data packages, including analytical raw data, microbiological test results, environmental&nbsp;monitoring results, and associated documentation for completeness, accuracy, and data integrity&nbsp;(including audit trail review). Serve as QA reviewer for analytical and microbiology-related deviations, OOS/OOT investigations, EM excursions,&nbsp;and other laboratory events. Assess and approve change controls relating to laboratory methods, instrumentation, workflows, and controlled&nbsp;documents. Perform routine GxP walkthroughs of laboratory areas, identify compliance gaps, document observations, and&nbsp;ensure timely resolution. Review and approve method validation protocols/reports, equipment qualification documents, and relevant SOPs. Provide QA representation during internal audits, regulatory inspections, and laboratory readiness activities. Act as QA subject matter expert (SME) for analytical testing, microbiological methods, and quality expectations&nbsp;related to cell therapy products.&nbsp; Pulling QC samples from the LN2 and storing IPC samples within the LN2. Support training and mentoring of QC staff on quality principles, documentation standards, and deviation/OOLS/OOT/CAPA management. Collaborate cross-functionally with QC labs, Manufacturing, Quality Systems, ASAT and Regulatory Affairs to support efficient sample testing and product release. Participate in continuous improvement initiatives to enhance data integrity, streamline workflow, and strengthen laboratory compliance. Contribute to risk assessments related to laboratory operations, equipment, and method lifecycle activities. Review of lab system entries, electronic data workflows, and lab system upgrades. Provide QA input during method transfers, new assay implementation, and introduction of new laboratory equipment or technologies. Requirements: Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific field required. · Advanced degree (MS) preferred but not required Minimum of 5 years of QA or QC experience in a regulated biopharmaceutical, cell therapy, biologics, or sterile manufacturing environment. · Demonstrated familiarity with analytical methods (e.g., flow cytometry, qPCR, ELISA) and microbiological techniques (e.g., sterility, endotoxin, bioburden, mycoplasma, EM).&nbsp; &nbsp;Prior experience reviewing laboratory data under cGMP required. Experience supporting or leading laboratory investigations (deviations, OOS, OOT, EM excursions) Strong working knowledge of cGMP, 21 CFR Parts 210/211, Part 1271, ICH guidelines, and data integrity (ALCOA+) principles.&nbsp; Understanding of laboratory instrumentation, method validation, equipment qualification, and change control processes. Experience with electronic systems such as LIMS, Empower, or other data acquisition platforms is preferred. Excellent attention to detail and strong decision-making skills. Ability to independently manage multiple priorities in a fast-paced, dynamic environment. Strong communication skills to partner effectively with laboratory, manufacturing, and quality teams. Ability to analyze technical data, identify compliance risks, and propose sound corrective actions. &nbsp; &nbsp; &nbsp; &nbsp;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.

QA Specialist 3, QC Oversight

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 &amp; 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 &nbsp;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.

Senior GMP Data Analytics Analyst Contractor

Position Summary The Sr. Manager of Validation will lead the Qualification and Validation, Cleaning, Sterility assurance and Computer System Validation (CSV) 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 engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment. The Sr. Validation Manger will be responsible for supporting the Validation/Qualification program by: Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change. Continuously improving the culture of the Validation team and the site Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.) Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members Direct support to OST head or lead annual OPEX budget for Validation department Staff and System Development Effective delegation and building confidence and competence within direct reports Drive engagement in the technical and personal development of the Validation team and members Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives Improve the culture of the Validation team and the site Qualifications Education/Training Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering with 10+ years work experience. A minimum of 8 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 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) Strong understanding of Validation Lifecycle (GAMP 5) principles Experience with calibration and maintenance management software Knowledge of electronic document management systems Experience with data integrity practices and compliance Strong technical writing skills for qualification documents, SOPs, and work instructions Ability to manage multiple projects simultaneously with minimal supervision Detail-oriented with excellent verbal and written communication abilities Ability to adapt to changing priorities in a deadline-oriented environment Significant hands on experience and regulatory expectations knowledge with controls, automation and computer system validation. Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage. Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques. Experience in writing computer system test scripts, validation protocols and summary reports 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.

Sr Manager Validation

Position Summary: The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations. This position is located onsite in Winston Salem, NC.&nbsp; &nbsp; Essential Duties &amp; Responsibilities: Lead and participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to other team members as needed.• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.• Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).• Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.• Perform and support investigations into deviations, incidents, and process improvements.• Lead efforts in process development, qualification, and validation activities as needed.• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment. Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards. Secondary Responsibilities: Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.• Provide guidance and support for continuous process improvement initiatives.• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.• Perform other duties as assigned to support and improve manufacturing operations. &nbsp; Minimum Qualifications: Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.• Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.• Skills/Abilities: Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.• Other: Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role. &nbsp;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.

Manufacturing Cell Processing Specialist 2

Position Summary: The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role provides on-the-floor guidance to manufacturing staff, supports execution of cell processing activities, and assists the Shift Manufacturing Supervisor with coordination of production activities. The Team Lead functions as a leader in manufacturing processes, promotes adherence to cGMP and aseptic techniques, and contributes to operational consistency, training, and continuous improvement. This position is located onsite in Winston Salem, NC. Essential Duties &amp; Responsibilities: Provide on-the-floor leadership and technical guidance during cell processing operations, supporting the manufacturing team in executing production activities safely and Serve as a technical guide for cell processing operations, including cell culture, expansion, harvesting, formulation, and cryopreservation. Support coordination of daily manufacturing activities to ensure alignment with the production schedule and operational priorities. Assist in task coordination and workflow organization during manufacturing operations to support efficient execution of batch activities. Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP and aseptic processing requirements. Support troubleshooting of process or equipment issues and escalate concerns to the Manufacturing Supervisor when appropriate. Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy and adherence to Good Documentation Practices (GDP). Support the development and training of manufacturing personnel on cell processing techniques, SOPs, and cleanroom practices. Contribute to deviation investigations, CAPA activities, and process improvements by providing technical input and operational knowledge. Assist with implementation or revision of manufacturing procedures, batch records, and documentation as processes evolve. Participate in daily tier meetings and communicate operational updates, risks, or resource needs to the Supervisor. Maintain compliance with safety procedures, cGMP regulations, and internal quality Support audit readiness and participate in inspections as Perform other duties as assigned to support manufacturing Minimum Qualifications: &nbsp; Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or equivalent; preferred area of study in a Science-related discipline. High School Diploma or Equivalent with relevant experience may be considered. Experience: Preferred minimum 4 years of relevant experience in biotechnology manufacturing or a related field. Skills/Abilities: Proficiency in biological processing techniques such as cell culture, ultra-filtration, and column Advanced knowledge of cGMP facilities and requirements. Strong organizational skills with the ability to manage multiple projects and meet deadlines. Critical thinking ability and judgment to make appropriate decisions within defined procedures. Other: Excellent eye/hand coordination, effective written and oral communication skills, team-oriented with a strong work ethic. &nbsp;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.

Manufacturing Cell Processing Team Lead

Position Summary The Senior Talent Acquisition Coordinator manages the logistics and administrative operations of the hiring process, ensuring a smooth and positive candidate experience. &nbsp;This role supports recruiters and hiring managers through interview scheduling, ATS management, and onboarding coordination. The position requires strong organization, communication, and proficiency with HR software systems. This role supports a fast‑paced Talent Acquisition function and requires comfort working with confidential information, managing shifting timelines, and coordinating across cross‑functional teams. This is a hybrid position based in Winston‑Salem, NC, requiring three days per week onsite, with additional onsite days as needed. Responsibilities Partner with TA colleagues to schedule candidates using Greenhouse applicant tracking system. Contribute to a successful candidate and hiring manager experience by ensuring all necessary details are communicated to candidates and interviewers 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 TA Partners to develop offer letters, launch background investigations and conduct timely candidate references. Track HireRight background investigations through completion. Collaborate with TA Partners to resolve any discrepancies/issues. Build strong relationships with candidates, ensuring clear communication and a positive experience throughout the hiring process. Manage job postings and maintain accurate applicant records in the Applicant Tracking System (ATS). Work with TA Partners to coordinate expense reporting and reimbursement. Supports Talent Acquisition by assisting with TA project tasks, running reports as needed, and managing related activities within the ATS. Provides logistical support for Talent Acquisition events and assists with event coordination and execution as needed. Qualifications 5+ years of experience in recruiting coordination, HR operations, or a fast-paced administrative role. Strong organizational skills with the ability to manage multiple calendars and shifting priorities. Excellent verbal and written communication skills for interactions with candidates and hiring managers. Proficiency with ATS platforms and Microsoft Office Suite High attention to detail, reliability, and a service‑oriented mindset. High School diploma required; Bachelor’s degree preferred or an equivalent combination of education and experience. &nbsp;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.

Sr TA Coordinator Contractor

The Associate Director of EHS – is responsible for leading and executing environmental, health, and safety programs across all ProKidney sites and operations to ensure regulatory compliance and a safe working environment. This role provides oversight for EHS strategy and partners cross-functionally with Manufacturing, Quality, Facilities, Supply Chain, and Laboratory teams to implement standardized safety programs, conduct risk assessments, manage hazardous materials and waste programs, and promote a proactive culture of safety consistent with regulatory and industry standards across the organization. Essential Duties &amp; Responsibilities Lead the development, implementation, and continuous improvement of EHS programs across all ProKidney sites, supporting laboratory, manufacturing, and operational environments. Establish standardized EHS policies, procedures, and safety management systems to ensure consistent safety practices across multiple locations. Conduct Job Hazard Analyses (JHAs), safety inspections, and risk assessments to identify hazards and implement mitigation strategies across facilities. Ensure organizational compliance with federal, state, and local environmental and safety regulations, including OSHA, EPA, CDC, and applicable biosafety and laboratory safety standards. Provide oversight of site EHS leads or local safety representatives, ensuring alignment with company-wide safety expectations and regulatory requirements. Oversee laboratory safety programs including chemical hygiene, biosafety practices, hazardous materials handling, and safe laboratory operations. Lead investigations of safety incidents, near misses, and environmental events across sites and drive corrective and preventive actions to prevent recurrence. Develop and deliver EHS training programs related to laboratory safety, chemical handling, hazardous waste management, emergency response, and workplace safety. Support hazardous waste management programs, chemical inventory systems, and environmental compliance programs across facilities. Partner with Quality and operational leadership to support internal audits, regulatory inspections, and continuous improvement initiatives across all ProKidney locations. Monitor EHS performance metrics and drive initiatives that improve safety culture, reduce risk, and support operational excellence. &nbsp; Education / Training Bachelor’s degree in Environmental Health &amp; Safety, Environmental Science, Industrial Hygiene, or related field preferred. Experience 7–10+ years of Environmental Health &amp; Safety experience, preferably within biotechnology, pharmaceutical, or life sciences manufacturing environments. Experience supporting multi-site operations or enterprise EHS programs in regulated environments. Experience supporting GMP manufacturing operations and regulatory compliance programs. Experience implementing safety management systems, risk assessments, and environmental compliance programs within regulated industries. Knowledge Working knowledge of OSHA, EPA, and applicable environmental health and safety regulations. Understanding of laboratory safety standards, biosafety practices, and hazardous materials management. Knowledge of EHS governance models supporting multi-site organizations. Skills Strong analytical and problem-solving skills with the ability to conduct hazard assessments and risk evaluations. Effective communication and training capabilities across scientific and operational teams. Ability to partner cross-functionally with Quality, Manufacturing, Facilities, Supply Chain, and laboratory personnel across multiple sites. Strong documentation and regulatory compliance mindset. Ability to influence safety culture and drive organizational alignment across geographically dispersed teams. Certifications / Licenses Associate Safety Professional (ASP), Certified Safety Professional (CSP), or equivalent certification preferred. Biosafety or laboratory safety certification preferred. 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.

Get a job referral to Prokidney

Description

Jobs· 10 open

About

Financials

Referrals

Your career is worth investing in.

Get unlimited referrals with Premium.