C

Cryoport Systems

Global temperature-controlled life sciences logistics

Validation Engineer - Consulting Services

Full-Time
$120k/yr+ Bonus + Stock + 401(k) match
Junior
Bachelor's
Irvine, CA, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A BA/BS degree is required.
  • At least 2 years of experience in biopharmaceuticals or the medical device industry.
  • At least 2 years of experience writing professional documentation with customer-facing materials.
  • Experience using Excel to create pivot tables, graphs, and meaningful visual and tabular analytics.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Teams.
  • Strong skills in math, statistics, and data analysis applications.
  • Strong organizational skills to manage multiple projects within overlapping timeframes.
Responsibilities
  • Participate in and oversee internal Consulting Services qualification processes.
  • Assist in developing validation procedures.
  • Perform internal validations by developing validation protocols and reports, preparing equipment, and documenting and analyzing test results.
  • Support project creation for shipping lane qualifications, packaging configurations, systemized operational qualifications, physical or thermal performance testing, and shipping feasibility studies.
  • Manage qualification activities for Consulting Services client-related projects.
  • Engage with clients by presenting validation plans in client collaboration meetings.
  • Develop and customize customer-centric, quality-driven protocols.
  • Coordinate with external third-party testing laboratories to ensure protocol execution, timelines, and quality metrics are achieved.
  • Evaluate, document, and articulate client-specific results.
  • Optimize existing protocols, processes, and reporting for validation activities.
  • Engage in continuous process improvement within Cryoport Systems Consulting Services.
  • Support cross-organizational departments as needed.
Desired Qualifications
  • Experience in cell and gene therapies.
  • Experience with ISO, IATA, ASTM, and ISTA standards relating to the pharmaceutical supply chain.
  • Experience with equipment and process validation using DQ, IQ, OQ, and PQ.
  • Knowledge of cGMP requirements and FDA and ICH guidelines.
  • Project management skills or training.
  • Understanding of cold chain and temperature-sensitive logistics.
  • Understanding of packaging testing and qualification.
  • Understanding of Good Distribution Practices.
  • Understanding of USP 36 Chapter 1079 Good Storage and Distribution Practices for Drug Products.
  • Understanding of ISO 21973 biotechnology general requirements for transportation of cells for therapeutic use.
  • Understanding of 21 CFR Part 210 cGMP in manufacturing, processing, packing, or holding of drugs.
  • Understanding of 21 CFR Part 211 cGMP for finished pharmaceuticals.

About the company

C

Cryoport Systems

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Cryoport Systems provides global, temperature-controlled supply chain services for life sciences, handling the logistics and storage of critical therapies, vaccines, and materials that must be kept at specific temperatures. Its offering includes end-to-end support for clinical trials and commercial products, ensuring products are kept at the right temperatures from pickup to delivery through specialized packaging, refrigerated storage, and temperature monitoring across a worldwide network. The company differentiates itself by providing an integrated, trusted cold-chain platform that covers multiple stages of the supply chain and is already supporting hundreds of clinical trials and leading therapies. The goal is to help life sciences companies move, store, and deliver irreplaceable products safely and efficiently, enabling patients to receive treatments on time.

Company Size

51-200

Company Stage

IPO

Headquarters

Brentwood, Tennessee

Founded

1990

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Simplify's Take

What believers are saying

  • Second-quarter 2026 revenue reached $49.0 million, with positive adjusted EBITDA.
  • Management raised 2026 guidance to $192 million-$196 million and maintained it on August 6.
  • China manufacturing started in 2026, reducing tariff exposure and opening local customer wins.

What critics are saying

  • Cryoport still reported a $0.20 adjusted loss per share on August 6, 2026.
  • CRYOPDP remained in discontinued operations after DHL bought it in June 2025.
  • Verismo and later-stage therapy concentration ties growth to FDA filings and approvals in 2026.

What makes Cryoport Systems unique

  • Cryoport linked 779 trials and 22 commercial therapies by June 30, 2026.
  • IntegriCell, launched in Houston and Liège, standardizes cell-therapy cryopreservation workflows.
  • MVE Fusion 800 ships without liquid nitrogen infrastructure, fitting hospital and biobank adoption.

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Benefits

  • Remote Work Options
  • Performance Bonus

Company News

PR Newswire
Aug 6th, 2026
Cryoport hits $49M revenue in Q2, reaches positive adjusted EBITDA milestone

Cryoport, a global provider of temperature-controlled supply chain solutions for life sciences, reported second quarter 2026 revenue of $49.0 million, representing 8% year-over-year growth. Life Sciences Services revenue increased 15% year-over-year, whilst BioStorage/BioServices revenue grew 25%. The company achieved positive adjusted EBITDA in the quarter, marking what CEO Jerrell Shelton called "an important milestone" in its pathway to sustainable profitability. Revenue from supporting commercial cell and gene therapy grew 9% year-over-year to $9.4 million. As of 30 June 2026, Cryoport supported 779 clinical trials globally, a net increase of 51 trials over the prior year. The company supports 22 commercial cell and gene therapies. During the quarter, four customers filed regulatory applications for new therapies.

MarketBeat
Aug 6th, 2026
CryoPort Q2 earnings call highlights.

CryoPort Q2 earnings call highlights. August 6, 2026 Key points. * CryoPort reported Q2 2026 revenue of $49 million and achieved $400,000 in positive adjusted EBITDA from continuing operations, while reaffirming its full-year revenue outlook of $192 million to $196 million. * Life Sciences Services led growth, with revenue up 15% year over year; cell and gene therapy commercial-support revenue rose 9% to $9.4 million, while clinical-trial support revenue increased 12% to $13.4 million across 779 supported trials. * The company improved cash generation, producing approximately $5 million in positive operating cash flow during the first half, and is expanding its network with new supply-chain centers in Paris and Santa Ana while developing products and services such as the Fusion freezer and IntegriCell. * MarketBeat previews the top five stocks to own by September 1st. CryoPort NASDAQ: CYRX reported second-quarter 2026 revenue of $49 million and said it reached positive adjusted EBITDA from continuing operations, while reaffirming its full-year revenue outlook of $192 million to $196 million. Chief Executive Officer Jerrell Shelton said revenue momentum continued during the quarter, led by the company's Life Sciences Services segment. Life Sciences Services revenue increased 15% from a year earlier, driven in part by 25% growth at BioStorage BioServices. The segment represented 57% of total quarterly revenue. The company noted that financial results from CRYOPDP, which was sold to DHL Group in June 2025 as part of a strategic partnership, are presented as discontinued operations. Unless otherwise noted, revenue figures discussed on the call referred to continuing operations. Cell and gene therapy activity expands. Revenue from supporting commercial cell and gene therapies rose 9% year over year to $9.4 million. The services portion of that revenue increased 26%, which Shelton attributed to a growing number of patients being treated in community and outpatient settings. Revenue from cell and gene therapy clinical-trial support increased 12% to $13.4 million. CryoPort supported 779 clinical trials globally at the end of the quarter, up by a net 51 trials from the prior year. Of those trials, 94 were in Phase III. Shelton said the company supports approximately 70% of clinical trials in the cell and gene therapy industry. The number of commercial therapies supported increased to 22 during the quarter after Orca Bio received FDA approval for TREGZI. Based on information currently available, the company expects that the remainder of 2026 could include 11 potential biologics license application or marketing authorization application filings, five new therapy approvals and one approval involving a label or geographic expansion. Chief Scientific Officer Mark Sawicki said financing conditions for cell and gene therapy programs had improved, although investment has been more concentrated in Phase II and Phase III programs than in Phase I studies. He said the focus on later-stage programs was favorable for CryoPort because commercialization activity provides a larger economic benefit to the company. During the second quarter, CryoPort added 29 clinical trials and removed 16, according to Vice President of Corporate Development and Investor Relations Thomas Heinzen. Of the removed trials, six were terminated and 10 were completed. Profitability and cash flow progress. CryoPort reported adjusted EBITDA from continuing operations of $400,000, an improvement of $1.3 million from the prior-year quarter. Shelton described the result as an important milestone in the company's pathway-to-profitability initiative. Discover more Stock Screener Tool Chief Financial Officer Robert Stefanovich said the company expects additional operating leverage as utilization increases across its network of global supply chain centers. He also said CryoPort generated about $5 million in positive net cash from operating activities during the first half of 2026, representing a $17 million improvement compared with the first half of 2025. The company maintained its revenue forecast despite first-half revenue of about $97 million and a second-quarter result that analysts characterized as ahead of consensus expectations. Shelton said CryoPort considered it prudent to retain the existing outlook because of geopolitical and macroeconomic uncertainties. Stefanovich said the assumptions underlying the company's 2026 outlook had remained largely unchanged and that demand for both Life Sciences Services and Life Sciences Products remained robust through the first half. Products, facilities and China strategy. In Life Sciences Products, CryoPort said MVE Biological Solutions benefited from demand from animal health customers and improved demand in the Americas. While products revenue was flat year over year in the second quarter, Shelton said the prior-year period was strong and that the business remained on plan. He said the company continued to expect product growth in the upper single digits for the full year. MVE began shipping several new products during the quarter, including the MVE Fusion 811 self-regenerating cryogenic freezer, which operates without cryogenic infrastructure or routine liquid nitrogen refills. The company also began producing cryogenic freezers in China and shipped initial orders of HE and open-top models equipped with newly introduced CryoVerse Connect controllers. Sawicki said the Fusion platform could help community-care hospitals support cell and gene therapies, and that CryoPort has seen significant industry interest in the offering. China represented about 2% to 3% of CryoPort's current revenue, Stefanovich said. Shelton said local manufacturing is intended to help the company avoid potential tariff issues and strengthen its competitive position in the country. He added that the company has increased its business-development focus in China, though he does not expect an immediate material contribution. IntegriCell and network expansion. CryoPort said IntegriCell cryopreservation services now has clinical processes operating in Houston and Liège, Belgium. The company was also selected by Verismo Therapeutics to support two clinical-trial CAR T-cell therapy programs. Sawicki characterized the Houston and Liège locations as proofing sites for a broader IntegriCell initiative. He said the service is expected to ramp modestly through 2026 and is not anticipated to be a significant revenue contributor this year, but could become a meaningful contributor over time as the industry adopts its standardized processes. The company also plans to open new global supply chain centers in Paris and Santa Ana, California, during the fourth quarter. Shelton said capital investment would decline as those facilities begin operations. CryoPort is also applying machine learning and generative artificial intelligence tools to automate routine work, analyze large datasets, manage risk and speed decision-making, Shelton said. He said the company has begun seeing measurable productivity benefits from those initiatives. About CryoPort (NASDAQ:CYRX). CryoPort, Inc NASDAQ: CYRX is a global provider of temperature-controlled logistics solutions for the life sciences industry. The company specializes in cryogenic shipping for critical biological materials, supporting the development, clinical testing and commercialization of cell and gene therapies, biologics, vaccines and reproductive medicine. By offering end-to-end supply chain management, CryoPort helps ensure the integrity and viability of temperature-sensitive products from point of origin to destination. CryoPort's product portfolio includes proprietary cryogenic dry shippers, advanced active and passive thermal packaging, and real-time data monitoring platforms. 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 CryoPort, 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 CryoPort wasn't on the list. While CryoPort currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. Robotics and automation are rapidly becoming essential infrastructure across healthcare, manufacturing, logistics, and many other industries. "Physical AI" is coming to the United States, and there are four ways that investors can gain exposure to this new robotics revolution. Plus, learn which seven companies are most positioned to benefit as intelligent robots enter the workforce.

Icebag China
Jun 26th, 2026
Cryoport supports Verismo KIR-CAR trials with integrated cryopreservation and cold chain platform.

Cryoport supports Verismo KIR-CAR trials with integrated cryopreservation and cold chain platform. Cryoport and Verismo highlight the cold chain complexity behind cell therapy trials. What happened. Cryoport announced that its Cryoport Systems IntegriCell cryopreservation services have been selected by Verismo Therapeutics to support Verismo's clinical KIR-CAR T cell therapy programs. Verismo is developing a multi-chain KIR-CAR platform for solid tumors and B-cell associated disorders. The two lead candidates are SynKIR(TM)-110 and SynKIR(TM)-310, both currently in Phase 1 clinical trials. The announcement is highly relevant to the cold chain sector because cell and gene therapy logistics depends on much more than ordinary refrigerated transport. These programs require controlled collection, cryopreservation, storage, chain of identity, chain of custody, validated movement and strict process consistency across clinical and manufacturing workflows. Cryoport said IntegriCell will support cryopreservation for Verismo's two lead clinical programs while integrating Verismo's existing proprietary cryopreservation process into Cryoport's global quality management system. How it works. Cell therapy cold chains are different from conventional pharmaceutical distribution. A typical pharmaceutical product may be manufactured in batches, packed into validated shippers and sent to distribution centers or healthcare providers. In cell therapy, the supply chain can include biological starting material, donor or patient collection, cryopreservation, manufacturing, release testing, storage, shipment and clinical administration. Each step must protect the biological material from thermal damage, process variability, contamination risk and identity loss. Cryoport's IntegriCell service is designed to provide process development, technology transfer and clinical cryopreservation services. According to the announcement, IntegriCell supports cell and gene therapy programs from clinical development into commercialization by providing standardized, manufacture-ready cryopreserved leukapheresis starting material within a globally standardized, GMP-compliant quality management system. The company's cryopreservation service centers are located in Houston, Texas and Liège, Belgium. These locations provide geographic coverage for programs in the Americas and Europe. Cryoport says the IntegriCell capabilities integrate with its broader temperature-controlled supply chain platform, including biologistics, biostorage and informatics. The company also referenced its Cryoshuttle temperature-controlled transport service and its strategic alliance with Gulf Coast Regional Blood Center to support high-quality allogeneic starting materials. In practical terms, this creates a connected workflow. Starting material can be collected, processed, cryopreserved, stored and moved through a single specialized supply chain partner rather than passing through loosely connected service providers. Why it matters. For advanced therapies, temperature-controlled logistics is not a downstream shipping task. It is part of the therapy's manufacturing and clinical execution model. Cryopreservation affects product consistency, manufacturing predictability and future scalability. If starting materials are handled inconsistently, the impact can appear later in production efficiency, quality control, batch release or clinical scheduling. This is why Verismo's CEO described cryopreservation as an important component of the manufacturing process and emphasized the need for a partner that could work within the company's existing workflow. The cold chain risk profile is also different. A conventional product may tolerate a defined refrigerated range for a limited period. Many cell therapy materials require cryogenic or ultra-low temperature conditions and may be irreplaceable if damaged. For autologous therapies, the material may be connected to one patient. For allogeneic programs, starting material quality affects manufacturing scale and reproducibility. This makes chain of identity and chain of custody as important as temperature control. A shipment can remain cold but still fail if the identity record, custody record or release documentation is incomplete. The Cryoport-Verismo announcement also reflects a broader trend: cell and gene therapy developers are increasingly looking for integrated infrastructure partners rather than isolated shipping vendors. As programs advance from early clinical work toward larger trials and potential commercialization, they need repeatable processes, global quality systems and scalable cold chain capacity. B2B impact. For cell and gene therapy developers, the key takeaway is to design cryopreservation and logistics strategy early. Supply chain planning should not wait until late-stage trials. Developers need to understand how starting material will be collected, frozen, stored, transported, released and tracked before the process scales. Any change to cryopreservation or logistics workflow can affect regulatory documentation and comparability. For CDMOs and clinical manufacturing partners, integrated cryopreservation can reduce variability in incoming material. More standardized starting material may improve scheduling, reduce manufacturing interruptions and support more consistent quality outcomes. For logistics providers, the announcement shows that advanced therapy customers need more than validated shippers. They need biologistics, storage, informatics, cryogenic handling, contingency planning and documentation systems that can withstand regulatory review. For cold chain packaging suppliers, this segment demands extreme performance. Cryogenic shippers, vapor-phase liquid nitrogen systems, ultra-low temperature containers and tamper-evident handling components must be qualified against the actual route, dwell time and clinical process. For data and visibility providers, the most important opportunity is identity-linked monitoring. A temperature record is useful, but for cell therapy it must connect to the right donor, patient, batch, manufacturing step and clinical site. Temperature data, location data, custody events and process records must be part of one auditable chain. For hospitals and clinical sites, the growth of advanced therapy programs means receiving teams need stronger procedures for frozen or cryogenic materials. That includes staff training, storage readiness, emergency contacts, receipt checks, documentation handling and escalation procedures if a shipper alarm or delay occurs. The broader cold chain lesson is that advanced therapies are turning logistics into a clinical quality function. Product integrity depends on cryopreservation science, chain-of-custody control, temperature performance, data integrity and operational scalability working together. Cryoport's role in Verismo's KIR-CAR programs is another example of how specialized cold chain infrastructure is becoming part of the therapy development pathway itself.

Yahoo Finance
May 4th, 2026
CryoPort Q1 revenue rises to $47.8M, supports record 766 clinical trials

CryoPort reported first-quarter fiscal 2026 revenue of $47.8 million, with double-digit growth in both its Life Sciences Services and Products segments. Commercial cell and gene therapy support revenue reached $9.1 million, whilst clinical trial-related revenue increased to $12.9 million. CEO Jerrell Shelton attributed the growth to momentum across the company's integrated services and products platform. The Life Sciences Products segment was driven by demand for MVE Biological Solutions cryogenic systems. CryoPort supported a record 766 global clinical trials as of 31 March, including 357 Phase II and 91 Phase III trials. Chief Scientific Officer Mark Sawicki noted continued investment into late-stage programmes, with Phase III trials increasing by five sequentially. Results exclude CRYOPDP, which was sold to DHL Group in June 2025.

PR Newswire
May 4th, 2026
Cryoport reports $47.8M Q1 revenue, up 16% YoY, raises 2026 guidance to $192M-$196M

Cryoport, a temperature-controlled supply chain solutions provider for life sciences, reported first-quarter 2026 revenue of $47.8 million, up 16% year-over-year. Commercial cell and gene therapy revenue grew 26% to $9.1 million, whilst clinical trial support revenue increased 18% to $12.9 million. Life Sciences Services revenue rose 18%, including 21% growth in BioStorage/BioServices. Life Sciences Products revenue increased 15%, driven by demand for cryogenic systems. The company supports 766 global clinical trials and 21 commercially approved cell and gene therapies. Adjusted EBITDA from continuing operations improved $2.2 million year-over-year to negative $0.6 million. Cryoport raised its full-year revenue guidance to $192 million–$196 million and held $403.6 million in cash and short-term investments as of 31 March 2026.