• Skip to primary navigation
  • Skip to main content
  • Skip to footer
ElevateBio

ElevateBio

Powering the creation of cell & gene therapies at a speed the world deserves.

  • Resources
    • Resources Overview
    • Elevated Insights
    • Presentations & Publications
    • Whitepapers
  • Media
    • Media Overview
    • Press Releases
    • Featured News
  • Facilities
  • Careers
  • Contact
  • Search
  • Manufacturing & Discovery Services
    • Manufacturing & Discovery Services Overview
    • Gene Editing Design & Optimization
    • Process Development
    • Analytical Development
    • cGMP Manufacturing
    • Next-Generation Sequencing
    • Quality
    • Regulatory CMC
    • Certifications & Compliance
    • Generative AI
  • Technologies
    • Technologies Overview
    • Gene Editing
    • Viral and Non-Viral Delivery
    • Messenger RNA (mRNA)
    • Induced Pluripotent Stem Cells (iPSCs)
  • Advanced Therapies
  • Partner With Us
  • About
    • About Overview
    • Our Journey
    • Our Team
    • Culture of Expedition
    • Careers
  • Media
    • Investors & Media Overview
    • Press Releases
    • Presentations & Publications
    • Elevated Insights
  • Careers
  • Facilities
  • Contact
  • Manufacturing & Discovery Services

    Manufacturing & Discovery Services Overview

    Capabilities & Services
    • Gene Editing Design & Optimization
    • Process Development
    • Analytical Development
    • cGMP Manufacturing
    • Next-Generation Sequencing
    Expertise
    • Quality
    • Regulatory CMC
    • Certifications & Compliance
    • Generative AI
  • Technologies
    • Technologies Overview
    • Gene Editing
    • Viral and Non-Viral Delivery
    • Messenger RNA (mRNA)
    • Induced Pluripotent Stem Cells (iPSCs)
  • Advanced Therapies
  • Partner With Us
  • About
    • About Overview
    • Our Journey
    • Our Team
    • Culture of Expedition
    • Careers
    • Investors

Market & Industry Insights

February 6, 2026 by

Throughout my career in cell and gene therapy, I’ve witnessed our industry evolve from scientific possibility to clinical reality. Yet as we scale these transformative therapies, I’m consistently reminded that success hinges not just on the elegance of the science, but on the pragmatic realities of manufacturing.

Choosing a cell therapy contract development and manufacturing organization (CDMO) isn’t a one-time vendor decision. It’s a strategic partnership that will determine whether your therapy reaches patients or joins the sobering percentage of programs that encounter preventable manufacturing setbacks.

Having led process development, manufacturing and global technology transfers early in my career at Bluebird bio, and now serving as Chief Technology Officer at ElevateBio, where I oversee programs across the industry, I’ve identified critical considerations that separate successful partnerships from costly misalignments. The following is a 10-question framework to help inform your decision when choosing a cell therapy CDMO, born from both industry best practices and hard-learned lessons. They’re designed to reveal not what CDMOs promise, but what they can prove and what will determine your program’s success.


1

What are your cell therapy manufacturing success rates?

In my experience, the most revealing metric isn’t what a CDMO highlights in presentations, but their comprehensive performance data. Request their first-time-right manufacturing success rate across all programs. While industry standards hover around 85-90%, exceptional organizations consistently exceed 95%. At ElevateBio BaseCamp, we’ve achieved 98%, though the number itself matters less than the transparency to share it.

Beyond headline metrics, examine deviation rates, failed batches, and out-of-specification results. These indicators reveal the operational consistency that ultimately defines your program. Remember, your batch performance becomes the FDA’s lens into your process control. Inconsistencies documented during early development often resurface as critical observations during BLA review.

2

What experience does your cell therapy manufacturing team have?

Leadership vision matters, but I’ve learned that program success depends on the expertise of those who actually handle your product. In our industry, average GMP manufacturing operator tenure runs one to two years – sufficient for basic proficiency but rarely enough to develop the expertise that distinguishes good from great.

At leading CDMOs, including ElevateBio BaseCamp, you’ll find operators with four to five years or more of specialized experience. Request to meet the manufacturing science, quality, and process development teams who will steward your program daily. Their backgrounds and tenure often predict your program’s trajectory more accurately than executive credentials.

3

Do you offer person-in-plant access during GMP manufacturing?

The question of access reveals much about a CDMO’s operational philosophy. What’s their formal position on person-in-plant presence? Can your team participate in training or observe clean room operations during GMP manufacturing? Is there a limit on the frequency of site visits or are there extensive pre-approvals to do so?

Some organizations restrict access, citing quality or confidentiality concerns. However, I’ve found that transparency typically indicates confidence in both systems and capabilities. At ElevateBio BaseCamp, we actively encourage client collaboration – whether working alongside our technicians during a technology transfer, observing through our in-suite, high-definition cameras, or participating in real-time problem-solving.

4

Can you optimize my cell therapy process or just execute manufacturing?

Nearly half of the programs we’ve worked with at ElevateBio BaseCamp have benefited from process optimization. This isn’t a reflection on our clients’ capabilities, but rather a recognition that cell therapy remains an evolving science where each program presents unique challenges.

Evaluate whether your potential partner maintains dedicated manufacturing science and technology teams that bridge development and production. Request examples of process improvements they’ve implemented. The distinction between a CDMO that merely executes protocols versus one that can scientifically troubleshoot and enhance and industrialize your process often determines whether you’ll navigate challenges successfully or encounter recurring obstacles.

5

Have you passed pre-approval inspection for cell therapy products?

Regulatory readiness extends beyond maintaining compliant systems. It requires demonstrating those systems under the scrutiny of commercial standards. If a CDMO hasn’t yet navigated a pre-approval inspection, investigate what commercial readiness validations they’ve pursued. Third-party certification, like the Initiative for Certification of Manufacturing Capabilities (ICMC™), provide independent verification of quality system maturity.

This consideration carries particular weight given the fact that a significant portion of FDA Complete Response Letters issued between 2020 and 2024 cite manufacturing or quality problems.1 The partnership decisions we make during early development often establish patterns that persist through regulatory review. It’s far more efficient to build commercial-ready rigor from the outset than to retrofit quality systems under regulatory pressure.

6

What’s your standard technology transfer timeline for cell therapy programs?

Technology transfer represents one of the most underestimated risks in our industry. I’ve seen programs lose momentum – and sometimes commercial competitiveness – due to protracted or failed transfers. Ask potential partners about their recent track record: How many transfers have you completed successfully over the past three years? What percentage met original timelines versus requiring extensions?

The financial and reputational costs of a failed CDMO relationship extend well beyond direct expenses. Programs can lose years and deplete resources that can’t be recovered, leaving teams to navigate compressed timelines with diminished funding. Historical performance, particularly with programs similar to yours, offers the clearest indicator of future success.

7

Can you scale cell therapy manufacturing from Phase 1 to commercial?

Success in cell therapy can paradoxically create its own challenges if your manufacturing partner lacks scaling capability. I’ve observed promising programs stall not from clinical failures but from inability to demonstrate manufacturing consistency at increased scale, a regulatory requirement that catches many teams unprepared.

Request concrete evidence of scaling experience: documented capacity expansion plans, not aspirations. Understand whether capacity is reserved for existing partners or subject to competitive allocation when demand peaks. Most importantly, verify they’ve successfully transitioned programs from clinical-scale production to commercial volumes while maintaining the consistency regulators require. Your manufacturing partner’s growth trajectory must align with your program’s ambitions.

8

What regulatory expertise and infrastructure do you provide for BLA submissions?

The FDA doesn’t just review your final product – they review your entire journey and product lifecycle. Can your CDMO demonstrate successful navigation of FDA feedback? How many INDs and BLAs have they actually supported? Do they have former FDA staff who understand how reviews really work, not just theoretical knowledge?

Equally critical is the digital infrastructure supporting your regulatory submissions. What systems ensure the data integrity FDA demands? Electronic batch records, integrated quality management systems, and comprehensive audit trails are regulatory requirements. Review the systems your CDMO has in place and ask for specific examples of how they’ve managed inspection observations to turn potential issues into approvals. The difference between a CDMO that reactively responds to regulatory requirements and one that proactively anticipates and addresses them often determines whether your program proceeds smoothly or encounters unexpected delays.

9

Was your facility purpose-built for cell therapy, and how does your team integrate new technologies?

There’s a fundamental difference between facilities designed for cell therapy and those retrofitted from other modalities. ElevateBio BaseCamp was built with FDA input specifically for multimodal, multiproduct production of cell, gene and mRNA therapies, with infrastructure optimized from material flow to contamination control and environmental monitoring. In contrast, so-called “flexible” facilities originally designed for stable molecules or well-characterized biologics are often compromised across these requirements.

Equally important is how that infrastructure evolves. The cell and gene therapy field evolves rapidly, yet many CDMOs hesitate to integrate innovations that could benefit their clients’ programs. Ask for specific examples of recently implemented technologies. How do they evaluate new automation or analytical methods? Do they have a technology development lab where innovations can be tested without risking GMP production? At ElevateBio BaseCamp, we’ve implemented more than ten new technologies in the past year alone, from automated processing platforms to advanced analytical methods. The willingness and capability to evolve with the science often distinguishes partners who will advance your program from those who might constrain it.

10

What are your sustainability commitments and environmental certifications?

Many biopharmaceutical companies look for environmental commitments from their suppliers, becoming just as important as quality systems in vendor selections. Ask how your CDMO considers environment and occupational health certifications. At ElevateBio BaseCamp, we pursued International Organization for Standardization (ISO) 45001 and 14001 certifications early, recognizing that our commercial partners would eventually require this level of rigor from their supply chain.

As we scale cell therapies toward broader patient populations, demonstrating sustainable manufacturing practices becomes part of our collective responsibility to deliver these treatments responsibly.


These questions are designed to reveal which partners truly understand the complexity of cell therapy manufacturing. The right CDMO won’t hesitate to share specific metrics, provide references, or open their doors for inspection. They’ll welcome these questions because they’ve already built their operations around answering them.

At ElevateBio BaseCamp, we built our operations specifically to address these challenges. From our purpose-built facilities to our experienced team and commercial scale, we welcome these tough questions.

Learn more about ElevateBio BaseCamp’s approach

References: 

  1. Slabodkin, Greg. “FDA’s CRLs Reveal 74% of Applications Rejected for Quality, Manufacturing Issues.” Pharma Manufacturing, 14 July 2025, www.pharmamanufacturing.com/all-articles/article/55302937/fdas-crls-reveal-74-of-applications-rejected-for-quality-manufacturing-issues.

Mike Paglia, Chief Technology Officer

Michael Paglia is the Chief Technology Officer at ElevateBio, a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise to accelerate the development of genetic medicines to treat human diseases. He has more than two decades of experience in facility design, start up, and operations ensuring the highest standards of quality, safety, and regulatory compliance. 

At ElevateBio, Michael led the design, construction and operations of the BaseCamp manufacturing facility that was recognized as the Facility of the Year, Operational Excellence by International Society for Pharmaceutical Engineering (ISPE) in 2021.  Michael established the process development and manufacturing capability and leads manufacturing operations, CMC regulatory, process/analytical development, and the advancement of innovative process technologies. 

Prior to ElevateBio, Michael was the Vice President of CMC Operations at Oncorus responsible for the development and manufacturing of novel genetically modified oncolytic herpes virus for the treatment of cancer and prior to that, Head of Technical Operations, Cellular Process Development and Manufacturing Operations at bluebird bio where he led the early process development, manufacturing, and global technology transfer of four approved genetically modified autologous cell therapies.  Early in his career at Tolerx, Michal lead process development, and late-stage manufacturing of novel therapeutic antibody products designed to treat patients by reprogramming the immune system.

Michael received his undergraduate degree from Providence College and a Master’s of Science in Biochemistry and Cellular Biology from the University of New Hampshire where he was honored with the Distinguished Alumni Award from the College of Life Science and Agriculture (COLSA) in 2023 for his career guidance and ongoing initiatives in COLSA to enhance STEM workforce development initiatives.

February 6, 2026 by

In the race to bring transformative cell and gene therapies to patients, speed often dominates early decision-making but industry data reveals a significant trend: between 2020 and 2024 a significant portion of FDA Complete Response Letters (CRLs) issued by the U.S. Food and Drug Administration involve manufacturing and quality issues.1 This industry trend is also reflected specifically in cell and gene therapy, where complex processes and novel modalities amplify the risk. These setbacks are rarely caused by last-minute missteps. More often, they trace back to decisions made years earlier during preclinical and Phase 1 testing when programs are under pressure to move fast and reduce costs.

A Predictable Pattern of Late-Stage Setbacks

Across the industry, the same challenges continue to emerge late in development. These findings don’t arise overnight – they expose gaps that were embedded in development programs years earlier.

The consequences surface at the worst possible moment: when a company is advancing toward approval, investor expectations are highest, and five or more years of development – and significant capital – have already been invested. The results are major approval delays, immense unplanned costs, and challenges that can fundamentally alter a company’s trajectory.

Cell Therapy Intensifies the Challenge

While these statistics highlight industry-wide trends, cell therapy adds unique challenges that magnify these risks. In this space, early decisions carry disproportionate weight: deficiencies in process design or scale-up can ripple through development and delay approval, even years later.

These risks tend to play out in consistent ways across programs, pointing to key areas that must be managed carefully to ensure successful development.

Critical issues to avoid:

Unresolved CMC and facility readiness issues, with critical details missing from Chemistry, Manufacturing, and Controls (CMC) packages, and manufacturing sites not fully prepared for FDA inspection

Assays not built for late-stage demand, often revealing limitations because they were designed for early research rather than commercial scale, robustness, and regulatory expectations

Product quality and manufacturing success-rate challenges, where teams struggle to consistently produce product that meets specifications, particularly around viability, stability, and other critical quality attributes

Difficulty scaling manufacturing, where processes that work at early stage can fail under commercial demand, making it hard to demonstrate comparability, reproducibility, or consistent performance

Building Success from the Start: ElevateBio Addresses the Root Causes

At ElevateBio, we’re focused on advancing the field of cell and gene therapy by combining genetic medicine technologies with manufacturing scale and expertise. So, we understand that manufacturing cell therapy is inherently complex, requiring robust processes, careful planning, and rigorous quality systems from the very start. This requires the right processes, the right people, and a quality-first mindset embedded from day one, so we can help our partners avoid the costly mistakes that set their programs back.

ElevateBio BaseCamp® is dedicated to the development and manufacturing of genetic medicines to address these challenges. Designed to be an integrated part of our partners’ development and approval journey, BaseCamp provides the foundation needed to withstand late-stage scrutiny and accelerate time to patients.

What sets ElevateBio BaseCamp apart:

  • A world-class team with proven experience manufacturing and releasing complex cell and gene therapy products
  • Expanding commercial manufacturing infrastructure engineered for reliability, scale, and regulatory readiness
  • Deep product understanding, supported by regulatory expertise and advanced analytical capabilities
  • A culture of quality and collaboration that prioritizes speed with accuracy, transparency, and true partnership

This combination matters because ElevateBio has already solved the problems others are discovering too late. Our partners benefit from established systems, extensive experience, and an operational model designed to anticipate regulatory and manufacturing challenges.

Manufacturing Setbacks are Not Inevitable

Many issues stem from rushing early development, choosing the wrong partners, or re-learning lessons the industry already knows.

The promise of genetic medicines is real. These therapies are transforming care for diseases once considered untreatable. But realizing that promise requires treating manufacturing as a strategic driver, not a downstream function. In cell and gene therapy, regulatory success is shaped years before submission and depends on partners with the right processes and quality systems in place from the start. That is what ElevateBio provides: the experience, infrastructure, and commitment to quality needed to turn scientific breakthroughs into approved therapies – and ultimately deliver them to patients who are waiting.

Learn more about ElevateBio BaseCamp’s approach

References: 

  1. Slabodkin, Greg. “FDA’s CRLs Reveal 74% of Applications Rejected for Quality, Manufacturing Issues.” Pharma Manufacturing, 14 July 2025, www.pharmamanufacturing.com/all-articles/article/55302937/fdas-crls-reveal-74-of-applications-rejected-for-quality-manufacturing-issues.

Cindy Riggins, Ph.D., Vice President, CMC Regulatory Affairs

Cindy Riggins, Ph.D. is Vice President, CMC Regulatory Affairs at ElevateBio. Cindy started her career in cell and gene therapies in 2001 at FDA/CBER as a post-doctoral fellow studying xenotransplantation and later transitioning to product reviewer for various cell therapy products. After leaving FDA in 2008, she has been involved in development of monoclonal, cell, and gene therapies through CMC Regulatory Affairs roles at AstraZeneca, Novartis, Autolus and ElevateBio. She was part of the regulatory team at Novartis responsible for submission and approval of Kymriah®, the first gene therapy product approved in the USA.

November 26, 2025 by

Over the past decade, our industry has witnessed the scientific promise of cell and gene therapies. Patients with rare diseases or hard-to-treat diagnoses now have new treatment options harnessing human cells and genes to alter disease. But the accessibility of these therapies the industry has developed remains constrained not by what’s biologically possible, but how they are designed and manufactured.

The field has reached an inflection point. We’ve demonstrated the scientific foundation and its curative potential. But to make advanced therapies sustainable as a pillar of medicine, we must make them more accessible. The companies that will define cell and gene therapy’s future will be those who can eliminate the distance between top science and efficient manufacturing.

Integration of Manufacturing and Therapeutic Design

Traditional small molecule drug development has very siloed development pathways: a therapeutic is designed and developed by one team and then manufactured by another. This approach is challenging in cell and gene therapy, often leading to delays, setbacks, or even outright failures. We built ElevateBio to solve this problem with a new approach, one in which therapeutic design and manufacturing operate as an integrated ecosystem.  

ElevateBio BaseCamp, our cGMP manufacturing business, goes beyond a traditional CDMO. We bring together expertise, advanced technologies, and state-of-the-art facilities to serve as a skilled partner to biopharmaceutical companies. This includes in-house manufacturing, process and analytical development, and quality control teams, all working in parallel to achieve tighter coordination and faster turnaround times. BaseCamp has industrialized genetic medicine manufacturing, achieving a 98% batch success rate across advanced programs.

Yet sustaining this success – and expanding it across new modalities – requires more than technical excellence alone.

Designing for Manufacturability from Day One

The future of cell and gene therapy depends on therapies designed with manufacturability in mind from the start – and into every stage of design. That’s why our team of process development scientists are embedded in design conversations early, creating commercial-ready processes in parallel with therapeutic development. Manufacturing insights flow back to inform molecular engineering in real time.

This includes integrating compact constructs and delivery systems engineered for both efficacy and efficiency. We apply scale-down and scale-up models to optimize performance, ensuring processes are fully scalable to GMP manufacturing and capable of meeting global demand.

We take the same approach through ElevateBio Life Edit, our gene editing technologies and R&D business. When our teams develop gene editors across all modalities, manufacturability is a design criterion from day one – not a constraint discovered in late-stage clinical trials. And by having BaseCamp and Life Edit sit alongside one another, we’re ensuring the latest manufacturing developments and insights flow back to inform R&D – and vice versa.

A Foundation for an Industry to Prosper

Looking beyond the science, what does a sustainable cell and gene therapy ecosystem require?

It’s more than better therapeutics. We need more treatment centers, expanding from dozens to hundreds for better patient access. The industry needs new commercial models that make advanced therapies economically viable for health systems. We need a whole new infrastructure where cell and gene therapy can become the standard of care for previously untreatable conditions.

But that infrastructure can’t be built upon unreliable manufacturing. We as an industry need to build a strong foundation – one built by designing, optimizing, and validating processes that reliably move therapies from bench to bedside. Without that foundation, the ecosystem simply can’t scale. And the window to build it is narrowing.

CAR-T is expanding into autoimmune indications with patient populations 10 times larger than oncology. In vivo therapies are advancing as new-generation modalities are adding layers of complexity. To support this growth, the field needs manufacturing designed for reliability and scale from day one.

Building What Comes Next

The field now needs the operational discipline and integrated thinking to deliver on that promise at population scale.

The therapies we’re developing today have the potential to transform millions of lives. But only if we build the systems to make them accessible, reliable, and sustainable.

At ElevateBio, we’re building that foundation by combining BaseCamp’s manufacturing platform with Life Edit’s R&D capabilities – and embedding therapeutic design expertise throughout. By doing so, we’ve created an integrated approach that’s building cell and gene therapy’s future and making a tangible impact for patients worldwide.

October 3, 2023 by

The story of American manufacturing is complicated. For much of the 20th century, it was the driving force in the American economy, with cities like Detroit, Pittsburgh, and Cleveland serving as hubs of industry. However, in recent decades, the landscape has undergone dramatic shifts. In 1979, manufacturing hit its peak of 19.6 million jobs, representing 22% of all nonfarm employment, and it’s never fully recovered. By 2019, manufacturing represented just 9% of all nonfarm employment. While the causes of this decline are complex and multifaceted, a few key factors stand out, including global competition, technological advances, and changing economic conditions, particularly recessions.

Despite these factors, American manufacturing is not dead. At ElevateBio, we aim to be a driving force in re-imagining and re-invigorating this sector by leading the way domestically and internationally in the biomanufacturing of cell and gene therapies (CGTs).

Biomanufacturing Represents the Future

Biomanufacturing – using living cells or organisms, such as bacteria or yeast, to produce pharmaceuticals, vaccines, and even biofuels – has tremendous potential. Over the last several decades, the promise of CGTs and their potential to treat – or even cure – diseases where there are no available therapies has become increasingly clear, and investment into these highly innovative medicines has skyrocketed. But our success in scientific discovery has given rise to other challenges:

  1. Scaling production from a few million cells in a research lab to manufacturing billions of cells needed to treat patients is uniquely complex.
  2. While science and innovation have dramatically advanced the discovery and development of CGTs, biomanufacturing advancements have lagged and relied mainly on traditional modes of development or a patchwork of technologies and providers, slowing the impact on human health.
  3. Crucially, the skilled labor force needed to manufacture these life-changing medicines is limited and clustered in a few small biotech hubs. To meet patient demand, we need more highly skilled manufacturing professionals and facilities, and we need to enable access to cutting-edge CGT facilities and expertise in more regions across the country and around the globe.

A Blueprint to Revitalize American Manufacturing

In a city historically known for its iron and steel manufacturing, we think future generations will hear “Pittsburgh” and know it for something else: biomanufacturing. Pittsburgh can serve as the model for how this powerful field can both revitalize manufacturing in key regions around the U.S. and fuel access to powerful new medicines for patients domestically and abroad.

In November 2021, the Richard King Mellon Foundation awarded the University of Pittsburgh a $100 million grant to create a biomedical manufacturing center at Hazelwood Green in Pittsburgh. Hazelwood Green was once the literal and metaphorical powerhouse of the city’s Greater Hazelwood. Coupled with the sprawling Jones & Laughlin plant across the Monongahela River, that South Side mill and the former Greater Hazelwood works combined to make Pittsburgh steel a key contributor to the World War II effort. It housed munitions production during World War II and following the war, it became a rolling mill, producing 10” bar steel critical to America’s growth. The decline and eventual closing of the mill in 1999 was a significant economic blow to the neighborhood. It marked the end of one type of manufacturing in Pittsburgh and a substantial source of job creation and revenue in the region.

Pittsburgh is an ideal location in which to extend ElevateBio’s manufacturing and technology, given that it sits at the intersection of science, technology, and talent. At ElevateBio, we have created an integrated ecosystem that combines R&D platforms with current Good Manufacturing Practice (cGMP), designed to power cell and gene therapy processes, programs, and companies to their full potential. BaseCamp® is our cGMP manufacturing and process development business that offers end-to-end capabilities for our partners and internal programs. Our flagship 140,000 sq. ft. BaseCamp facility is located in Waltham, Massachusetts, and in 2022, we announced our geographic expansion to Hazelwood Green in Pittsburgh through a 30-year partnership with the University of Pittsburgh and the R.K. Mellon Foundation. Our planned BaseCamp expansion in Pittsburgh will enable an even greater number of biopharmaceutical companies, innovators, physicians, and scientists to translate revolutionary science and research from bench to bedside. At the same time, we’ll bring more than 170 permanent full-time jobs, 900 construction jobs, and 360 off-site support jobs to Pittsburgh.

Importantly, this partnership builds on Pittsburgh’s leadership position in manufacturing technologies and the University of Pittsburgh’s innovative research. The University of Pittsburgh’s nationally ranked and internationally regarded School of Medicine and research across the health sciences are a natural fit for ElevateBio — after all, this was where Jonas Salk cured polio. The unique ecosystem that makes Pittsburgh so attractive for this initiative also exists in many other formerly great manufacturing regions in the U.S., opening up the potential for growth and a roadmap for revitalizing manufacturing in the U.S.

Training the Biomanufacturing Workforce of the Future

At ElevateBio, we know that talent is key to catalyzing a new technology-driven bioeconomy in Pittsburgh and beyond. To accomplish this objective, we are working to create high-skilled jobs and train a new generation of manufacturing workers.

Here is how:

We have workforce development, local trade, and community college outreach programs to help train and develop professionals with varying levels of education.

We aim to advance careers through continuous hands-on training and professional development activities in multiple disciplines, providing opportunities for individuals changing careers and young professionals entering the job market.

We offer high-paying job opportunities to a broad spectrum of individuals that will serve them well over the lifetime of their careers, whether at ElevateBio or another company in the bioeconomy in the future.

ElevateBio is putting our expertise and our money where they count. In Pittsburgh, we estimate the cost of our hands-on training and professional development activities will be over $40 million. This includes the salary required for highly skilled trainers (Ph.D.’s.), the wages of trainees, and consumable costs per person per month, with additional resources necessary to continue talent development as new technologies and techniques emerge. An anticipated 50% of employees in Pittsburgh will have a trade school, community college, or bachelor’s degree level of education; the remainder will be industry experts and individuals with advanced degrees.

Our workforce development program focuses on our mission to power the creation of life-transforming cell and gene therapies, at a speed the world deserves; this is a key motivator for all our employees each and every day. Training is conducted in a classroom or laboratory setting where new staff can learn and ask questions to ensure they have a strong understanding of both how and why they are carrying out an activity. We provide the education and tools for individuals to be successful not only during their time in a particular role but also in different departments or other companies as their careers advance. The education that our employees receive through our programs provides them with the fundamentals of product development and in-depth training for their specific job functions.

In addition to training and continuing education, we offer competitive salaries, benefits, and leave policies to all full-time employees to attract and retain talent. We believe that through investments in a highly skilled manufacturing workforce, we can also advance the local economies in which we do business.

We’re Helping to Drive the Next American Manufacturing Revolution

Western PA is on a journey of becoming a premier U.S. biomanufacturing center: it has all of the elements necessary for success – research institutions as well as medical facilities providing clinical care, patient monitoring, and tracking of health outcomes – that are also all reasons we chose to expand into the region. Through our continued expansion and commitment to powering the field of cell and gene therapy for decades to come, ElevateBio is creating jobs, building a new generation of highly skilled manufacturing workers in America, and looking for synergies globally. Through this effort and our cutting-edge technology platforms, we are accelerating access to technologies and expertise that have the power to change the future of medicine. We’re looking for innovators and partners who want to join us in pioneering the future of CGT and the biomanufacturing economy. Come work with us as we seek to usher in the next great wave of American manufacturing.

Footer

ElevateBio

Investors & Media

LinkedIn Twitter

© 2026 ElevateBio. All Rights Reserved.

Privacy & Cookie Policy

  • Manufacturing & Discovery Services
  • Technologies
  • Advanced Therapies
  • Partner With Us
  • About
  • Presentations & Publications
  • Elevated Insights
  • Careers
  • Facilities
  • Contact
MENU
  • Manufacturing & Discovery Services
    • Manufacturing & Discovery Services Overview
    • Gene Editing Design & Optimization
    • Process Development
    • Analytical Development
    • cGMP Manufacturing
    • Next-Generation Sequencing
    • Quality
    • Regulatory CMC
    • Certifications & Compliance
    • Generative AI
  • Technologies
    • Technologies Overview
    • Gene Editing
    • Viral and Non-Viral Delivery
    • Messenger RNA (mRNA)
    • Induced Pluripotent Stem Cells (iPSCs)
  • Advanced Therapies
  • Partner With Us
  • About
    • About Overview
    • Our Journey
    • Our Team
    • Culture of Expedition
    • Careers
  • Media
    • Investors & Media Overview
    • Press Releases
    • Presentations & Publications
    • Elevated Insights
  • Careers
  • Facilities
  • Contact