Training: The Real Constraint in CGT Manufacturing

The cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) market is projected to grow 10x from $6.41 billion to roughly $75 billion by 2034 (see Figure 1).1 However, FDA Form 483 observation trends2 tell a different story than one would gather from investment headlines. Recurring observations include incomplete training documentation, absence of written training procedures, failure to qualify personnel for assigned tasks, and the absence of a structured program for ongoing competency (detailed in Table 1). This discrepancy stems from a workforce being asked to expand on deliverables while remaining undertrained, under retained, and inadequately transitioned into the very roles they are hired to fill and execute. What follows is a cost-based argument for why training infrastructure is the variable that will separate the organizations still standing in 2034 from the ones that did not make it.

The financial influx surrounding the investment in CGT manufacturing right now is genuinely striking. Johnson and Johnson committed $1 billion to a new facility in Montgomery County, PA, in February 2026, projecting more than 500 hires and committing to a production-ready date of 2031.3 Towards Healthcare, citing Precedence Research data, puts the global CGT CDMO market at a compound annual growth rate of roughly 28%, projecting a near 12-fold expansion over the present decade.1

However, what those figures fail to show is this harsh reality: between 2020 and 2024, 74% of Complete Response Letters issued to CGT developers by the FDA cited quality or manufacturing deficiencies as the primary cause.4 In the same period, approximately 40% of investigational new drug applications were either rejected or outright stopped before reaching clinical evaluation as a result of inadequate chemistry, manufacturing, and controls.4 These are not the numbers of an industry that has its execution problem solved, or even close to being so. In fact, they are the numbers of an industry that has accelerated past its own operational readiness. The question is, why and how? A quick analysis of the pattern in FDA 483 observations from the same period shows exactly where these breakdowns are taking place.

How is Training Seen in FDA 483 Trends?

A review of FDA Form 483 observations issued to biopharmaceutical manufacturers during fiscal year 2024 identified several recurring categories, all related to training deficiency: incomplete training documentation, absence of written training procedures, failure to qualify personnel for their assigned tasks, and no structured training program to maintain ongoing competency (see Table 1).2 These observations were not limited to startups or first-time facilities being inspected. Established CGT manufacturers received them as well.

The reason this pattern repeats itself is worth examining carefully. Training gaps in good manufacturing practice (GMP) environments are rarely fixed by uploading additional content to a learning management system (LMS). The LMS takes on the role of becoming an electronic repository of written procedures, but a completion report is not the same as training infrastructure. It is just a document repository with associated quizzes that serve to demonstrate a required procedure has been read. However, knowledge of all material read during a session is rarely retained, and the practical application of said knowledge is an entirely separate skill that requires repetition, failure, and troubleshooting. So, when the inspectors come with their questions, they rarely ask whether the course was completed, as it is assumed it is. Rather, they ask if the person doing the work can demonstrate competency in each area, and those are two very different questions.

Under 21 Code of Federal Regulations (CFR) 211.25, personnel engaged in manufacture, processing, packing, or holding of a drug product must possess the education, training, and experience required for their assigned functions.5 Training must be conducted by qualified individuals, must cover the specific tasks the employee performs, and must include current GMP requirements. In a CGT facility, those tasks routinely include lentiviral vector handling, autologous cell processing, chain-of-identity management, and closed-system bioreactor operation. Applying the 211.25 standard to those environments is not a matter of checking a training completion box. An inspector standing in front of an operator who cannot explain why chain-of-identity controls exist, or what the consequence of a deviation in that step is, has found a training deficiency regardless of what the LMS record claims.

What is the Burn Rate in High Turnover GMP Environments?

The workforce problem strengthening this compliance picture is well-documented. A 2025 survey by the International Society for Cell and Gene Therapy found manufacturing and process development as the largest gap in the entire CGT workforce, with shortages greatest in technical laboratory, manufacturing, and quality control (QC) roles.6 A 2024 BioPlan Associates survey, as reported by Locwin, found that vacancy rates in critical CDMO positions, specifically manufacturing science and technology (MSAT), quality assurance, and automation engineering, exceeded 15% at many sites. The result was seen in major delays during technology transfer timelines and a significant increase in deviation frequency.7

The industry response has been unsurprising. To mitigate these serious concerns, increased money has been thrown at the problem: larger salaries, elevated offers, title inflation, aggressive counteroffers, and extreme poaching. Not to say this approach is not understandable, as it does address immediate hiring pressure, but it fails to address what happens 12 months after you have placed new talent in a broken system.

The Society for Human Resource Management reports that replacing an employee costs between 50% and 200% of their annual salary when both direct and indirect expenses are fully accounted for.8 Direct costs are familiar: recruiting fees, time-to-fill, onboarding administration, and formal training. The indirect costs are where GMP environments diverge sharply from general industry. An operator less than six months into their role represents a documentation exposure in every batch record they sign. A quality associate who has not yet internalized investigation methodology represents a deviation-handling vulnerability that can surface in the next FDA inspection. A trainer who was never formally qualified is generating training records that an investigator can challenge on their face. These are not theoretical risks. They are the conditions described repeatedly, in the existing 483 observations.

The math is simple. From personal experience, when the chimeric antigen receptor (CAR)-T therapy boom first began in Northern NJ around 2013-2014, starting with Celgene and Novartis, the average cost to train a new operator was roughly equal to 1/3 to 1/4 of their starting salary, culminating in a roughly $75,000-$85,000 investment per operator once materials and trainer time were accounted for. Using the SHRM midpoint estimate, total replacement cost, including training investment, recruitment, and productivity loss, falls in the range of $75,000 for a manufacturing-level role.8 At a facility of 100 employees running 40% annual turnover, that generates 40 replacement events per year at a cost of approximately $3 million. At 20% turnover, the same facility spends roughly $1.5 million. That $1.5 million annual gap is not the result of paying people more (see Table 2). It is the result of whether the organization gave employees a reason to stay.

What Will Separate the Operations That Survive?

There is a recognizable profile to the organizations most at risk in the current expansion cycle. They have invested heavily in equipment and facilities. They carry significant overhead from paying competitive salaries. Many have implemented an LMS and consider the training question largely resolved. Unfortunately, reading and understanding only go so far. What is missing, consistently, is a sufficient training architecture built to create repeatable outcomes with minimal variance regardless of the individual working through it. A structured system connects role-specific competency requirements to a progression pathway from hire to fully qualified and does so in a way that enables the operator to understand not just the how, but the why. Implement documented checkpoints along that pathway and a visible career development model that answers the question every new employee is asking: What will my future here look like?

The career development component is the one most frequently absent, yet it is the main driver of unnecessary turnover.

When a CGT manufacturing operator leaves six months after completing onboarding, the departure is rarely about salary alone. In most cases, no competitor offered them a dramatically better compensation package. They received a marginally higher offer accompanied by a title that suggested forward movement. The incumbent employer lost that person not because they were outbid, but because they never communicated a development trajectory. The competitor did not offer a better job. They offered a story about the future.

Building that story is not a significant capital investment. A tiered qualification program, a structured mentorship arrangement, and a documented promotion framework require organizational design time and a committed training budget. They are operational decisions, not capital expenditures. Organizations that have made them consistently report lower voluntary turnover, more predictable inspection performance, and a workforce that can respond to FDA questions with documented evidence rather than a completion certificate.

The distinction the FDA draws during an inspection is the same one that determines whether an organization can scale. A training program designed to generate records is a compliance theater. A training architecture designed to produce competent operators is the actual product.

Regional Investment and the Workforce Readiness Gap

The concentration of CGT manufacturing investment along the mid-Atlantic corridor right now is not subtle. J&J's $1 billion Montgomery County commitment requires 500 qualified employees, and they are not waiting until 2031 to start hiring. Validation work starts well before product runs, which means they are going to be qualifying operators in a facility with no production history, on a regulatory timeline that cannot slip, while every other CGT site in the Philadelphia corridor is fishing in the same talent pool simultaneously.3

So where does that workforce come from? The honest answer is that nobody really knows yet, and that is the problem. The ISCT survey from 2025 flagged that the US Department of Education has acknowledged that biomanufacturing workforce development is lagging current market demand.6 Community college partnerships are valuable. Regional workforce initiatives are a start. But enrollment to GMP-qualified operator is a multi-year process, not a quarterly one. Any organization banking on hiring a ready-made workforce from the existing market is going to run headfirst into a 15% vacancy rate and realize the market was never going to supply what they needed.7

The workforce must be built internally. That means onboarding programs designed to compress qualification time without creating the documentation gaps that show up in 483 observations. It means training systems where inspection-ready records come out the other end of normal operations, not out of a remediation sprint two weeks before an audit. And it means giving people a reason to still be there in year two.

Conclusion

The $75 billion projection is real. The pipeline behind it is real. Nobody is disputing that this market is going where analysts say it is going.1

What is not modeled in any of those projections is what it costs to deliver on them with an undertrained, high-turnover workforce. A $60,000 salary and $60,000 in training costs represent $120,000 walking out the door every time someone leaves before they have returned that investment to the organization. Run that math at 40% annual turnover across a hundred-person facility, and there is a $3 million annual burn rate that does not show up on any capital expenditure line, does not depreciate on a schedule, and compounds every year the underlying problem is not fixed.

The CDMOs that are still standing at the end of this decade are not necessarily going to be the best funded or the most scientifically sophisticated. They are going to be the ones that figured out earlier than their competitors that they cannot inspect their way to a competent workforce and they cannot salary their way to a retained one. Infrastructure must be built that produces both, and it must be done before the FDA performs an inspection.

The floor is not the LMS completion report. It never was. It is whether the person on the manufacturing floor can tell an investigator what they are doing, why it matters, and what happens when it goes wrong. Everything else is compliance theater.

References

1. Cell and gene therapy CDMO market size, share, trends, growth rate to 2035. Towards Healthcare. Published November 1, 2025. Accessed March 2026. https://www.towardshealthcare.com/insights/cell-and-gene-therapy-cdmo-market-sizing
2. Top FDA 483 observations from 2024 and strategies to mitigate them in 2025. PRP Compliance Group. Published July 12, 2025. Accessed March 2026. https://www.prp-compliance.com/post/understanding-the-top-7-fda-483-observations-from-2024-and-strategies-to-mitigate-them-in-2025
3. J&J plans $1B investment in PA cell therapy manufacturing facility. BioSpace. Published February 19, 2026. Accessed March 2026. https://www.biospace.com/drug-delivery/j-j-plans-1b-investment-in-pa-cell-therapy-manufacturing-facility
4. Why gene and cell therapies are stalling at the FDA. Drug Discovery News. Published August 3, 2025. Accessed March 2026. https://www.drugdiscoverynews.com/why-gene-and-cell-therapies-are-stalling-at-the-fda-16527
5. Personnel qualifications, 21 CFR §211.25. Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-B/section-211.25
6. International Society for Cell and Gene Therapy Laboratory Practices Committee. Shaping the future of cell and gene therapy workforce development: training of cell therapy processing personnel. Cytotherapy. Published online April 10, 2025. Accessed March 2026. https://www.sciencedirect.com/science/article/abs/pii/S1465324925006802
7. Locwin B. Science, scale, and skills: what will define the CGT CDMO champions. BioProcess International / Workforce Genetics. Published April 30, 2025. Accessed March 2026. https://workforcegenetics.com/science-scale-cell-gene-therapy-cdmo-market/
8. Society for Human Resource Management. Turnover cost calculation spreadsheet and benchmarking data. Updated 2025. Accessed March 2026. https://www.shrm.org/topics-tools/tools/forms/turnover-cost-calculation-spreadsheet