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

ProKidney is seeking an experienced research associate for our cell therapy process development team. The ideal candidate will have a strong background in cell therapy or upstream biopharmaceutical development, including process characterization and optimization. In this role, you will support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a great opportunity for individuals who are passionate about making an impact in the evolving field of cell therapy.
Responsibilities:
<ul>
<li>Execute experiments to optimize and improve processes for cell therapy manufacturing, including but not limited to media preparation, cell expansion and harvest, and product formulation. Analyze experimental data and present results in a clear and actionable manner to stakeholders.</li>
<li>Provide technical feedback as part of development and implementation of new techniques and technologies. Support troubleshooting and process improvement initiatives.</li>
<li>Work closely with cross-functional teams, including manufacturing science and technology, analytical development, quality control, and quality assurance to ensure study findings are accurately summarized and reported in a timely manner.</li>
<li>Support the characterization of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards.</li>
<li>Ensure that all process development activities adhere to GMP and applicable regulatory standards. Support regulatory filings and audits as needed.</li>
<li>Preparation and review of technical documentation, including process development reports, batch records, SOPs (Standard Operating Procedures), and change controls.</li>
<li>Assist in identification of potential risks in process development and manufacturing and help implement strategies for mitigation, ensuring the successful advancement of cell therapy programs.</li>
</ul>
&nbsp;
Qualifications:
<ul>
<li>Bachelor’s or master’s degree in chemical engineering, biomedical engineering, biochemistry, cell biology, biotechnology, or a similar field.</li>
<li>2 plus years of experience in cell therapy and /or biopharmaceutical upstream process development. Ability to execute cell culture processes in typical lab settings, from vial thaw through cell expansion and harvest. Experience in aseptic techniques is required.</li>
<li>Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.</li>
<li>Strong problem-solving abilities, critical thinking, and the ability to collaborate with cross-functional teams. Strong verbal and written communication skills, including technical writing.</li>
<li>Understanding of GMP, GLP, and regulatory requirements for the development of cell-based therapies.</li>
<li>Must be comfortable handling human tissues and primary human cells.</li>
<li>Occasional weekend/off shift work may be required as part of this role.</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>

Research Associate 1, Process Development Contractor

Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells, potentially preventing or delaying the need for dialysis or transplant.
Quality Control (QC) Microbiology Analyst I supports ProKidney’s QC Microbiology department performing Routine Environmental Monitoring and Microbiological testing. This role involves working closely with manufacturing and support operations, collecting and testing environmental and utility samples, and ensuring timely documentation and reporting. The Analyst will work a 5/8 schedule (Sunday–Thursday or Monday-Friday), with weekend and holiday support. Shifts from either 0700–1600, 0800–1700 or 1030-1930.
Essential Duties &amp; Responsibilities: 
<ul>
<li>Perform routine Environmental Monitoring (EM) of GMP-controlled areas</li>
<li>Support Personnel Monitoring during Manufacturing Operations</li>
<li>Perform testing on Microbiological samples (Bioburden, Endotoxin, sterility)</li>
<li>Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements</li>
<li>Participate in revising, and training on SOPs, WIs, Forms, and Protocols</li>
<li>Supports lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification</li>
<li>Maintain inventory levels in QC labs and coordinate material requests with the warehouse</li>
<li>Perform enumeration, gram staining, streaking and isolation of recovered organisms</li>
<li>Complete documentation accurately and in a timely manner</li>
<li>Maintain high hygiene standards required for cGMP cleanroom operations</li>
<li>Other duties as assigned</li>
</ul>
Minimum Qualifications:
<ul>
<li> Education/Training: High School Diploma or greater</li>
<li> Experience: 1–2 years of relevant experience; prior work in a GMP facility is highly desirable</li>
<li> Knowledge: Basic understanding of GMP regulations and cleanroom behavior Basic understanding of cGMP microbiology lab practices</li>
<li>Familiarity with LIMS is a plus</li>
</ul>
<ul>
<li> Skills: Ability to read and follow schedules and instructions Strong organizational skills and attention to detail Ability to work independently and in a team environment Comfortable with compliance-driven work and documentation Proficient in Microsoft Office (Excel, Word, Visio, etc.) Good hand-eye coordination Ability to lift up to 30 pounds, bending, lifting and squatting required. Effective verbal and written communication skills Dependable with a strong work ethic</li>
<li> Certifications/Licenses: None required</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>

QC Microbiology Analyst 1

The Quality Assurance Specialist II, Batch Release (contractor) supports Quality Operations by conducting detailed reviews of executed manufacturing, packaging, labeling, and laboratory records used in material and product disposition. The role verifies that documentation is complete, accurate, traceable, and compliant with approved procedures, specifications, data integrity requirements, and current Good Manufacturing Practice (cGMP) requirements. The Specialist partners with Manufacturing, Quality Control, Supply Chain, and other functions to resolve documentation issues, assess quality events, and ensure release decisions are supported by complete and compliant records.&nbsp;
&nbsp;

<div>This is a contractor position located onsite in Winston-Salem, NC. This role is not eligible for ProKidney benefits or remote/hybrid work. Schedule flexibility, including overtime, may be required based on business needs.</div>
Essential Duties and Responsibilities&nbsp;
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Compile and perform initial quality review of batch disposition documentation, confirm that required manufacturing and testing records are complete, and verify that applicable deviations, investigations, and other quality events are assessed or resolved in accordance with approved procedures before recommending the batch for final disposition.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Monitor production and non-production activities for compliance with cGMP requirements and promptly document and escalate observed issues.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; evaluate and document the</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Compile and perform initial quality review of batch disposition documentation, confirm that required manufacturing and testing records are complete, and verify that applicable deviations, investigations, and other quality events are assessed or resolved in accordance with approved procedures before recommending the batch for final disposition.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Monitor production and non-production activities for compliance with cGMP requirements and promptly document and escalate observed issues.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; evaluate and document the potential impact of quality events on affected materials, batches, and disposition timelines.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Review and provide quality input on standard operating procedures, change controls, protocols, and other controlled documents.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="7" data-aria-level="1">Support the implementation, maintenance, and continuous improvement of regulated quality systems and procedures.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="8" data-aria-level="1">Track and report batch review status, documentation deficiencies, release cycle times, recurring discrepancies, quality risks, and other performance indicators; escalate barriers that may affect compliant and timely disposition to Quality Management.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="9" data-aria-level="1">Participate in internal, customer, and regulatory audits and support timely responses to audit observations, as assigned.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="10" data-aria-level="1">Collaborate with Manufacturing, Quality Control, Supply Chain, Regulatory, and other cross-functional partners to resolve documentation discrepancies, obtain required information, communicate batch review status, and support compliant and timely material and product disposition.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="11" data-aria-level="1">Maintain current knowledge of relevant regulations, industry standards, and quality practices.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="12" data-aria-level="1">Perform other duties and quality-related assignments as needed.&nbsp;</li>
</ul>
Minimum Qualifications&nbsp;
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Bachelor’s degree in life sciences, engineering, quality, or a related field and at least two years of relevant experience in a regulated pharmaceutical, biotechnology, medical device, or similar environment; or an associate degree and at least four years of relevant experience. An equivalent combination of education and experience may be considered.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Working knowledge of cGMP requirements, quality systems, deviation management, root cause analysis, and CAPA processes.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Experience reviewing executed batch records, manufacturing documentation, laboratory records, or quality documentation for completeness, accuracy, data integrity, traceability, and compliance; direct experience supporting material or product disposition in a pharmaceutical or biotechnology environment preferred.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Familiarity with applicable FDA, EU, and ISO regulatory frameworks preferred.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Strong attention to detail, sound judgment, and the ability to identify, communicate, and escalate quality risks.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Ability to organize and prioritize multiple assignments, meet deadlines, and deliver accurate work in a fast-paced environment.&nbsp;</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 2, Batch Release Contractor

Position Summary&nbsp; The Quality Assurance Specialist I, Batch Release performs routine review and administrative activities that support material and product disposition. Working under established procedures and regular guidance, the role reviews executed manufacturing and laboratory documentation for completeness, accuracy, and compliance; records review status; identifies discrepancies; and escalates issues to more experienced Quality personnel. This position builds foundational knowledge of cGMP requirements, data integrity, quality systems, and batch release processes.&nbsp;
&nbsp;
This is a contractor position and will not be eligible for ProKidney benefits. This position is located onsite in Winston Salem, NC and is not eligible for remote or hybrid work. This position will require flexibility and overtime as needed depending on the needs of the business.&nbsp;
&nbsp;
Essential Duties and Responsibilities&nbsp;
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Review routine executed manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Verify documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Identify documentation discrepancies, communicate findings, and escalate potential compliance or release-impacting issues.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Compile batch disposition documentation and confirm required records are available for review.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Enter and maintain accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Support follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="7" data-aria-level="1">Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="8" data-aria-level="1">Perform routine production-area observations and promptly report potential cGMP concerns.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="9" data-aria-level="1">Complete required training, maintain current knowledge of assigned procedures, and participate in continuous improvement activities.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="10" data-aria-level="1">Perform other quality-related duties as assigned.&nbsp;</li>
</ul>
Minimum Qualifications&nbsp;
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Bachelor’s degree in life sciences, engineering, quality, or a related field; or an associate degree with at least two years of relevant experience in a regulated environment. An equivalent combination of education and experience may be considered.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Ability to follow detailed procedures, recognize documentation errors, and escalate concerns appropriately.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Strong attention to detail, organization, and written and verbal communication skills.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Ability to manage routine priorities, meet deadlines, and work effectively with guidance.&nbsp;</li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="2" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Proficiency with Microsoft Word and Excel; exposure to electronic quality or document management systems preferred.&nbsp;</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, Batch Release Contractor

The Associate Director, IT GxP &amp; Quality Systems, leads strategic programs within the Company's regulated technology landscape and serves as the primary technology partner for Quality Systems. This role is accountable for the delivery, governance, optimization, compliance, and lifecycle management of GxP technology platforms, with primary ownership of the Quality Management Systems (QMS) environment.
The role drives technology solutions that enable compliant business processes across Quality, Clinical, Regulatory, Manufacturing, Technical Operations, and other GxP-regulated functions. The Associate Director connects technology execution with departmental strategy, ensuring systems scale effectively to support the organization's evolving clinical, manufacturing, and commercialization needs. The role leads cross-functional initiatives, manages external partners, and continuously improves Quality Systems capabilities while maintaining regulatory compliance and inspection readiness. The Associate Director level is characterized by leading programs with strategic impact, driving outcomes at scale, and connecting execution to departmental strategy with emphasis to transform processes to support commercialization.&nbsp;
Key Responsibilities:
GxP &amp; Quality Systems Leadership
<ul>
<li>Lead the Enterprise GxP and Quality Systems portfolio, including strategy execution, governance, delivery, operations, support, and lifecycle management.</li>
<li>Own the Quality Management Systems environment, including roadmap execution, enhancements, integrations, system administration, and ongoing optimization.</li>
<li>Drive process harmonization, automation, continuous improvement initiatives, and future-state Quality Systems.</li>
<li>Lead strategic technology programs supporting Quality, Clinical, Manufacturing, Regulatory, and Technical Operations functions</li>
</ul>
Technology Delivery &amp; Portfolio Management
<ul>
<li>Oversee implementation, enhancement, integration, validation, release, and support activities across the GxP application portfolio.</li>
<li>Manage technology priorities, roadmaps, vendor deliverables, and system lifecycle activities to ensure reliable business operations.</li>
<li>Partner with business stakeholders to translate operational requirements into scalable and compliant technology solutions.</li>
<li>Recommend technology improvements and business process enhancements that improve efficiency, compliance, and user experience.</li>
</ul>
&nbsp;
Compliance &amp; Validation
<ul>
<li>Ensure compliance with applicable GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, data integrity requirements, and CSV/CSA expectations.</li>
<li>Lead validation activities including requirements management, risk assessments, testing strategy, traceability, validation documentation, and release readiness.</li>
<li>Maintain inspection readiness across the Quality Systems landscape and support regulatory inspections, audits, and compliance assessments.</li>
<li>Establish appropriate governance, system controls, audit trail requirements, electronic signature controls, user access structures, and data ownership standards.</li>
</ul>
&nbsp;
Cross-Functional Leadership
<ul>
<li>Lead cross-functional teams and strategic initiatives involving Quality, Clinical, Regulatory, Manufacturing, and Information Technology stakeholders.</li>
<li>Influence decision-making using subject matter expertise in Quality Systems, compliance, validation, and regulated technology environments. Associate Director roles are expected to provide discipline leadership and drive strategic outcomes within their specialized area.</li>
<li>Coordinate priorities across functional partners to ensure alignment between business objectives and technology delivery.</li>
<li>Coach project teams and technology partners on Quality Systems best practices, compliance expectations, and governance standards.</li>
</ul>
Vendor &amp; Partner Management
<ul>
<li>Manage technology vendors, consultants, implementation partners, and service providers to ensure quality delivery and achievement of business objectives.</li>
<li>Monitor vendor performance, service quality, project outcomes, and contractual obligations.</li>
<li>Support budgeting, forecasting, and resource planning activities related to the GxP application portfolio.</li>
</ul>
&nbsp;
Qualifications:
<ul>
<li>Education/Training: 
<ul>
<li>Bachelor’s degree in Life Sciences, Pharmacy, Engineering, IT, or related field.</li>
<li>10+ years of experience in pharmaceutical, biotechnology, medical device, or other regulated industries.</li>
</ul>
</li>
<li>Experience:
<ul>
<li>Significant experience leading GxP and Quality Systems within a pharmaceutical, biotechnology, or other regulated life sciences environment. At least 10 plus in management of digital capabilities.</li>
<li>Strong hands-on experience with Quality Management Systems; MasterControl experience strongly preferred.</li>
<li>Experience with GxP platforms supporting Quality, clinical operations, cell and gene therapy, chain of identity/chain of custody, or other regulated business processes; TrakCel or other market chain of identity/chain of custody experience strongly preferred for commercialization.</li>
<li>Experience with other leading industry platforms such as Veeva is highly desirable.</li>
<li>Demonstrated experience leading QMS implementations, system configurations, and continuous improvement initiatives.</li>
<li>Experience managing GxP application portfolios, vendors, and implementation partners.</li>
<li>Experience with enterprise-wide deployment and support of quality management.</li>
<li>Experience with broader Quality IT portfolio (LabVantage, LIMS).</li>
</ul>
</li>
</ul>
&nbsp;
<ul>
<li>Knowledge:
<ul>
<li>Deep understanding of pharmaceutical Quality processes, GxP requirements, and the technology supporting regulated business processes.</li>
<li>Strong knowledge of computerized system validation/assurance (CSV/CSA), data integrity, electronic records, audit trails, and quality risk management.</li>
<li>Knowledge of cGMP facilities and cGMP requirements.</li>
</ul>
</li>
</ul>
&nbsp;
<ul>
<li>Skills:
<ul>
<li>Excellent stakeholder, program management, communication, and leadership skills.</li>
<li>Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through completion and meet deadlines.</li>
<li>Ability to exercise judgment within defined procedures and practices to determine appropriate action.</li>
<li>Detail oriented with strong analytical and problem-solving skills.</li>
<li>Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders.</li>
<li>Expected to keep up to date on regulatory changes for data integrity, US FDA 21 CFR Part 11 and EU Annex 11 compliance.</li>
</ul>
</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, IT GxP & Quality Systems

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

<h2>Position Summary:</h2>
ProKidney is seeking a Senior Director, Biostatistics to serve as the statistical lead for its pivotal Phase 3 program. This highly visible, hands-on role requires a technically strong statistician who can operate strategically while remaining close to the work.
The Senior Director will lead statistical strategy, analysis, interpretation, and reporting for complex clinical trial data, while supporting regulatory interactions, topline readout, and future submission activities. The ideal candidate will bring deep statistical expertise, strong drug development judgment, FDA-facing experience, and the ability to collaborate effectively across clinical development, regulatory, data management, data science, pharmacovigilance, quality, and executive leadership.
<h2>Essential Duties &amp; Responsibilities:</h2>
<ul>
<li>&nbsp;Phase 3 study lead; accountable for not only study read out but all biostatistics elements that will subsequently feed into a BLA, such as the integrated safety summary.</li>
<li>Provide hands-on statistical leadership for study design, statistical analysis plans, data interpretation, reporting, and regulatory deliverables.</li>
<li>Key member of the cross functional core study team who represents the interests of the biostatistics deliverables while overseeing the overall study conduct.</li>
<li>Escalation point and oversight of all external vendors, such as WCG for the Endpoint Adjudication committee and Icon for Central Laboratory</li>
<li>Functional lead of the biostatistical team</li>
<li>Leader who maintains composure and creative problem solving in a flexible, fast paced</li>
<li>Accountable author of the statistical analysis plan, tables listings and figures shells, and subsequent documentation</li>
<li>Provide statistical leadership for complex issues including randomized versus treated populations</li>
<li>Leads trial design, protocol development, analysis planning, interpretation of results and preparation of regulatory submissions</li>
<li>Generates statistical models to improve methods of evaluating quantitative and qualitative data, identifying relationships and trends in data and factors affecting research results.</li>
<li>Support FDA-facing discussions and help advocate for appropriate analytical approaches in a complex and differentiated therapeutic setting.</li>
<li>Provides ad hoc data driven analyses</li>
<li>Independently research, propose, teach and implement advanced statistical analyses</li>
<li>Accountable and responsible for biostatistics SOP development and maintenance</li>
<li>Contribute to executive-level program updates, including biweekly interactions with senior leadership regarding study progress, key risks, upcoming milestones, and decision points.</li>
</ul>
<h2>Minimum Qualifications:</h2>
<ul>
<li>Education/Training:</li>
<li>Advanced degree in Statistics, Biostatistics, Mathematics, or related Ph.D. preferred.</li>
<li>Minimum of 10 years of pharmaceutical and/or biopharma industry experience, including design and analysis of clinical studies (cell therapies/biologics a plus).</li>
<li>Formal education in statistics, biostatistics or the mathematical sciences</li>
<li>Experience leading and reading out late stage programs</li>
<li>Broad clinical trial expertise</li>
<li>Must have strong statistical academic background, knowledge of quantitative methods including predictive modeling techniques.</li>
<li>Proficiency in SAS, R, Python or related data analysis languages</li>
<li>Experience with study design and data analysis from a range of different phases of clinical development.</li>
<li>Prior experience with studies involving nontraditional treatment logistics,</li>
<li>Prior involvement in BLA/NDA submission planning and execution.</li>
<li>Proficiency with Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).</li>
<li>Must have excellent interpersonal, communication, writing and organizational</li>
<li>Must have excellent analytical skills in order to filter, prioritize and validate potentially complex and dynamic material from multiple sources.</li>
<li>Proven ability to meet strict</li>
<li>Excellent organizational skills and time management</li>
<li>Excellent attention to detail and accuracy maintaining consistently high-quality</li>
<li>Self-motivated and</li>
<li>Ability to establish and maintain effective working relationships with coworkers, managers and clients.</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>

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