Full-Time

Manufacturing Cell Processing Supervisor

ProKidney

ProKidney

201-500 employees

Develops cell therapy to treat CKD

No salary listed

No H1B Sponsorship

Winston-Salem, NC, USA

In Person

Bachelor's, Associate's

Category
Biology & Biotech (1)

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Requirements
  • Associate or Bachelor’s degree in Biotechnology, Biology, Chemistry, or related scientific discipline preferred.
  • High School Diploma or equivalent may be considered with significant relevant experience.
  • Minimum 4 years of experience in GMP-regulated manufacturing required.
  • 7+ years of manufacturing experience may substitute for a degree.
  • Previous supervisory or team leadership experience required.
  • Strong knowledge of cGMP regulations and quality systems applicable to biologics manufacturing.
  • Experience with aseptic processing and cleanroom manufacturing environments.
  • Understanding of FDA and EMA regulatory requirements for biologics manufacturing.
  • Familiarity with environmental monitoring and facility control procedures
  • Experience working with ERP systems and production documentation systems.
  • Strong technical writing skills for deviations, SOPs, and manufacturing documentation.
  • Certifications/Licenses: None required.
Responsibilities
  • Lead daily manufacturing operations and supervise production personnel to ensure safe, compliant, and efficient execution of manufacturing activities in a cGMP aseptic manufacturing environment. Maintain a strong presence on the manufacturing floor during critical process steps and support troubleshooting as needed.
  • Coach, develop, and manage manufacturing staff through training, performance management, one-on-one meetings, and career development planning. Support recruiting, hiring, onboarding, and maintaining training readiness for all team members.
  • Oversee execution of the production schedule and coordinate staffing, suite readiness, and raw material availability in partnership with Supply Chain and cross-functional teams to ensure on-time delivery of manufacturing plans.
  • Ensure accurate and timely completion and review of manufacturing documentation including batch records, logbooks, deviations, change controls, and ERP transactions to support compliant production and batch release.
  • Maintain compliance with cGMP, regulatory, and safety requirements while ensuring continuous inspection readiness and supporting internal and external regulatory audits.
  • Support operational improvements and technology transfer activities, including implementation of new processes from Product Development to Manufacturing, participation in continuous improvement initiatives, and development of technical documentation such as SOPs and deviations.

ProKidney develops rilparencel, a cell therapy designed to preserve kidney function in patients with advanced chronic kidney disease (CKD). The product is in late-stage clinical trials, and the goal is to delay or potentially avoid the need for dialysis by slowing the loss of kidney function. The treatment works by using transplanted or administered cells to support kidney tissue and function, offering a therapeutic option beyond standard care. ProKidney plans to commercialize rilparencel through sales to healthcare providers and direct-to-patient access, with potential partnerships with providers and insurers to expand access. The company differentiates itself by pursuing a first-in-class cell therapy specifically for CKD and focusing on a large, underserved patient population in the United States. Its mission is to transform CKD care by providing a treatment that preserves kidney function and reduces the burden of dialysis for millions of patients.

Company Size

201-500

Company Stage

IPO

Headquarters

Winston-Salem, North Carolina

Founded

2015

Get referred to ProKidney

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • CJASN published positive Phase 2 REGEN-007 data in January 2026.
  • Greg Madison joined March 2026 to build commercial launch readiness.
  • Leadership now spans commercial and CMC execution ahead of Phase 3 enrollment completion.

What critics are saying

  • PROACT 1 topline lands Q2 2027; one bad readout kills the story.
  • ProKidney had $181.6 million cash June 30, 2026, funding only into mid-2027.
  • One asset, rilparencel, faces existential FDA and reimbursement rejection after approval.

What makes ProKidney unique

  • Rilparencel is the only Phase 3 cell therapy for advanced CKD.
  • FDA aligned in July 2025 on eGFR slope for accelerated approval.
  • ProKidney owns autologous kidney-cell manufacturing and added Ken Locke June 2026.

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Benefits

Health Insurance

Flexible Work Hours

Paid Sick Leave

Paid Holidays

Growth & Insights and Company News

Headcount

6 month growth

-2%

1 year growth

-3%

2 year growth

1%
MarketBeat
Aug 10th, 2026
ProKidney (NASDAQ:PROK) releases earnings results, misses estimates by $0.01 EPS.

ProKidney (NASDAQ:PROK) releases earnings results, misses estimates by $0.01 EPS. August 10, 2026 Key points. * ProKidney missed quarterly expectations: The company reported a loss of $0.15 per share versus the $0.14 consensus estimate and revenue of $0.15 million, below estimates of $0.19 million. * Shares remain under pressure: PROK traded at $1.69, near its 52-week low of $1.45, with a market capitalization of approximately $510.5 million. * Analyst sentiment is mixed: ProKidney has a "Moderate Buy" consensus rating and a $12 average price target, while institutional investors own 51.59% of the stock. * Five stocks to consider instead of ProKidney. ProKidney (NASDAQ:PROK - Get Free Report) released its quarterly earnings results on Monday. The company reported ($0.15) EPS for the quarter, missing the consensus estimate of ($0.14) by ($0.01), FiscalAI reports. The firm had revenue of $0.15 million for the quarter, compared to analyst estimates of $0.19 million. ProKidney stock performance. PROK traded up $0.05 during trading on Monday, reaching $1.69. 1,229,470 shares of the company's stock were exchanged, compared to its average volume of 997,319. The company's fifty day moving average price is $1.72 and its 200-day moving average price is $1.89. The firm has a market capitalization of $510.48 million, a PE ratio of -3.19 and a beta of 1.66. ProKidney has a fifty-two week low of $1.45 and a fifty-two week high of $3.48. Analyst Ratings changes. PROK has been the topic of several research reports. Weiss Ratings raised ProKidney from a "sell (e+)" rating to a "sell (d-)" rating in a report on Friday, July 10th. Wall Street Zen lowered ProKidney from a "sell" rating to a "strong sell" rating in a research note on Saturday, May 16th. Finally, HC Wainwright reiterated a "buy" rating and issued a $12.00 price target on shares of ProKidney in a report on Monday, May 18th. One equities research analyst has rated the stock with a Strong Buy rating, one has assigned a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company's stock. Based on data from MarketBeat.com, ProKidney has an average rating of "Moderate Buy" and an average price target of $12.00. Institutional inflows and outflows. Several hedge funds and other institutional investors have recently made changes to their positions in PROK. Millennium Management LLC acquired a new stake in shares of ProKidney during the third quarter worth $4,734,000. JPMorgan Chase & Co. boosted its holdings in ProKidney by 3,024.9% during the second quarter. JPMorgan Chase & Co. now owns 1,668,642 shares of the company's stock worth $988,000 after buying an additional 1,615,243 shares during the last quarter. Geode Capital Management LLC grew its position in shares of ProKidney by 9.2% during the 4th quarter. Geode Capital Management LLC now owns 1,197,530 shares of the company's stock worth $2,684,000 after buying an additional 100,748 shares during the period. Renaissance Technologies LLC increased its stake in shares of ProKidney by 578.6% in the 4th quarter. Renaissance Technologies LLC now owns 895,705 shares of the company's stock valued at $2,006,000 after acquiring an additional 763,705 shares during the last quarter. Finally, Bank of America Corp DE raised its position in shares of ProKidney by 12.4% in the 2nd quarter. Bank of America Corp DE now owns 846,154 shares of the company's stock valued at $501,000 after acquiring an additional 93,322 shares during the period. 51.59% of the stock is currently owned by institutional investors. ProKidney company profile. ProKidney, Inc NASDAQ: PROK is a clinical-stage biotechnology company focused on developing cell-based therapies for kidney diseases. The company's research and development activities center on harnessing human-derived proximal tubule cells to address conditions such as acute kidney injury (AKI) and chronic kidney disease (CKD). By targeting the underlying cellular mechanisms of renal injury and dysfunction, ProKidney aims to offer novel regenerative medicine approaches that go beyond current supportive care options. Discover more Stock Split Calculator American Consumer News ProKidney's lead programs utilize proprietary methods for isolating and expanding renal epithelial cells to create injectable therapeutic products. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider ProKidney, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and ProKidney wasn't on the list. While ProKidney currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. The AI wave will soon hit public markets with Anthropic and OpenAI set to go public later this year. However, you don't have to wait to invest. This report shows seven AI stocks that you can buy today while the big model providers get ready to go public.

GlobeNewswire
Jun 2nd, 2026
ProKidney appoints Kenneth Locke as Chief Technical Officer.

ProKidney appoints Kenneth Locke as Chief Technical Officer. Kenneth Locke joins as Chief Technical Officer, bringing more than 25 years of experience across Chemistry, Manufacturing and Controls (CMC) and Supply Chain as ProKidney progresses toward the potential commercialization of rilparencel. June 02, 2026 08:00 ET | Source: ProKidney WINSTON-SALEM, N.C., June 02, 2026 (GLOBE NEWSWIRE) - ProKidney Corp. (Nasdaq: PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today announced the appointment of Kenneth Locke as Chief Technical Officer. "Ken is an accomplished leader with a proven ability to scale advanced therapy platforms and execute complex manufacturing strategies," said Bruce Culleton, M.D., CEO of ProKidney. "As we approach our pivotal topline readout in Q2 2027 and advance toward commercialization, his leadership will be critical in strengthening our technical foundation and ensuring we are well-positioned for long-term success." Mr. Locke joins ProKidney from Carisma Therapeutics, where he oversaw CMC, Quality and Regulatory functions and led technical strategy for first-in-human CAR Myeloid programs. He built and scaled teams to support clinical development and contributed to strategic asset transitions through licensing and technology transfer of cell and viral vector manufacturing processes. Previously, he held leadership roles at Celgene (now Bristol Myers Squibb), where he led external manufacturing and strategic sourcing for cell therapy programs, and at Novartis, where he helped advance early-stage cell therapy programs and established global capabilities across manufacturing and supply chain. "The opportunity to help advance a first-in-class autologous cell therapy for patients with severe chronic kidney disease is incredibly compelling," said Mr. Locke. "ProKidney has built a strong foundation with its in-house manufacturing capabilities and expertise in kidney disease, and I'm energized to work with this talented team as we execute on our Phase 3 study and prepare for the next stage of growth." Mr. Locke began his career in research and procurement roles of increasing responsibility at Bristol Myers Squibb and other biopharmaceutical organizations. He holds a Master of Science in Molecular Biology from Lehigh University and a Bachelor of Science in Biology Education from Millersville University of Pennsylvania. About ProKidney Corp. ProKidney, a pioneer in the treatment of CKD through innovations in cell therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT(R), is a first-in-class, patented, proprietary autologous cell therapy with regenerative medicine advanced therapy designation that is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) study for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. For more information, please visit www.prokidney.com. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the achievement and timing of the topline data readout of the Company's PROACT 1 trial and other milestones provided, the Company's beliefs that its Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval, eGFR slope can be used as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company's expectation that current cash will support operating plans into mid-2027, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company's products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company's products, if approved, the advancement of the Company's development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to the Company's product candidates, and the advancement and funding of the Company's developmental programs, generally. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. Media Contact Audra Friis [email protected] Investor Relations Contact Daniel Ferry [email protected]

Yahoo Finance
Mar 31st, 2026
ProKidney beats Q4 revenue estimates, advances rilparencel towards FDA approval

ProKidney Corp. announced fourth-quarter revenue of $893,000, beating consensus estimates of $600,000. The company provided updates on rilparencel, its chronic kidney disease treatment currently advancing through regulatory pathways. CEO Bruce Culleton highlighted 2025 achievements including positive Phase 2 study results for REGEN-007, FDA alignment on accelerated approval pathway, and strong enrolment for the Phase 3 PROACT 1 study. The company expects to complete PROACT 1 enrolment this year, with pivotal data expected in second quarter 2027. ProKidney develops cell therapies for chronic kidney disease, with rilparencel in Phase 3 clinical trials alongside various cryopreserved versions in different trial phases. The company aims to address treatment gaps for patients with advanced chronic kidney disease and diabetes at high risk of kidney failure.

Associated Press
Mar 25th, 2026
ProKidney appoints Greg Madison as chief commercial officer to drive rilparencel strategy

ProKidney Corp, a late-stage cell therapy company focused on chronic kidney disease, has appointed Greg Madison as chief commercial officer. Madison will drive ProKidney's commercial strategy as the company advances towards potential commercialisation of rilparencel, its lead product candidate. Madison brings over 20 years of executive leadership experience in biopharmaceuticals. Most recently, he served as chief executive officer of Shield Therapeutics. He previously led Keryx Biopharmaceuticals, transforming it from clinical to commercial stage and launching a phosphate binder for dialysis patients. Earlier, he held senior roles at AMAG Pharmaceuticals and Genzyme, where he helped drive Renagel/Renvela to over $1 billion in annual revenue. ProKidney is developing rilparencel, an autologous cell therapy currently in Phase 3 trials for patients with advanced chronic kidney disease and type 2 diabetes.

MarketScreener
Mar 25th, 2026
ProKidney expands senior leadership team with appointment of Greg Madison as Chief Commercial Officer.

ProKidney expands senior leadership team with appointment of Greg Madison as Chief Commercial Officer. Published on 03/25/2026 at 04:01 pm EDT Acquiremedia WINSTON-SALEM, N.C., March 25, 2026 (GLOBE NEWSWIRE) - ProKidney Corp. (Nasdaq: PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today announced the appointment of Greg Madison as Chief Commercial Officer. In this role, Mr. Madison will drive ProKidney's commercial strategy as the Company advances towards the potential commercialization of rilparencel. "Greg is a seasoned commercial biopharma executive with a proven track record of building high-performing organizations, shaping strategy, and preparing innovative therapies for market," said Bruce Culleton, M.D., CEO of ProKidney. "He brings valuable operational and leadership skills needed to help guide ProKidney through its next phase of growth, including strong depth in nephrology and other specialty markets. As we advance our clinical and regulatory objectives for rilparencel, Greg will play a key role in strengthening our leadership team and positioning rilparencel for potential commercialization." Mr. Madison brings more than two decades of executive leadership experience across commercial strategy, general management, launch planning, business development, and company building in both clinical and commercial-stage biopharmaceutical companies. Most recently, he served as Chief Executive Officer of Shield Therapeutics plc, where he redesigned the commercial strategy, identified and led a transformative business development transaction, and raised capital to position the company on a path to profitability. Previously, he was Chief Executive Officer of Melt Pharmaceuticals, creating the company and advancing a novel sublingual combination drug from preclinical to Phase 2. Prior to that, he served as President and CEO of Keryx Biopharmaceuticals, leading its evolution from a clinical to commercial-stage organization, launching a novel iron-based phosphate binder for dialysis patients, and advancing a second indication for iron deficiency anemia. Earlier in his career, Mr. Madison was Executive Vice President and Chief Commercial Officer of AMAG Pharmaceuticals, and Vice President/General Manager of the Global Renal Business at Genzyme, where he helped drive Renagel/Renvela to blockbuster status with over $1 billion in annual revenue. "ProKidney is developing a truly novel cell therapy with the potential to address a profound unmet need for patients with advanced CKD and diabetes," said Greg Madison. "As a potential first cell therapy for CKD patients and nephrologists, I am excited to join the Company at such an important time. I look forward to working alongside Bruce and the broader team to shape the commercial strategy, organization, and execute the plans needed to support the potential launch of rilparencel." About Chronic Kidney Disease CKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes over 1 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD. About ProKidney Corp. ProKidney, a pioneer in the treatment of CKD through innovations in cell therapy, was founded in 2015 after a decade of research. ProKidney's lead product candidate, rilparencel (also known as REACT(R), is a first-in-class, patented, proprietary autologous cell therapy with regenerative medicine advanced therapy designation that is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) study for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes. For more information, please visit www.prokidney.com. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. ProKidney's actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the advancement of our clinical and regulatory objectives for rilparencel and, if approved, potential commercialization of rilparencel. Most of these factors are outside of the Company's control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company's Class A common stock on Nasdaq; the inability of the Company's Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company's clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company's drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company's products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's financial performance; the Company's intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company's business; and other risks and uncertainties included under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. ProKidney Contact Ethan Holdaway [email protected] Investor Relations Contact Daniel Ferry [email protected] Media Contact Audra Friis [email protected] 2026 GlobeNewswire, Inc., source Press Releases (C) Acquiremedia - 2026