The biopharma industry is at a critical moment of growth, yet across the sector the prevailing sentiment is that a workforce shortage is limiting available talent and constraining capacity. To address these constraints, most companies default to increasing headcount as the quickest and simplest solution. Leaders often default to hiring because it appears faster than redesigning training systems and operating models.

Hiring alone does not resolve the underlying issue as the real constraint is an organization’s ability to develop operational proficiency at scale. The reality is that this mindset needs to shift from increasing headcount to prioritizing competency-based training and systems. Rather than asking how many people are required, the question must become how we build proficiency at scale.

The Paradox of Growth

The data tells a story that there is a shortage of people and that we need more. Surveys of industry executives consistently report significant skills shortages, with roughly one-third identifying workforce capability gaps¹ as a critical constraint, but layoffs are up. These numbers are actually a symptom of the failure to create proficiency.

The reflexive stopgap solution is to poach talent and hire in mass numbers, which leaves the entire industry in a costly ‘hire-train-lose’ cycle where companies recruit aggressively, train employees under compressed timelines, and then lose experienced staff to competing facilities. This cycle has ultimately contributed to turnover rates often reported in the low-to-mid teens² across biopharma manufacturing roles. With the reshoring effort and domestic manufacturing investment we’ve seen over the past year, more manufacturing plants are expected to come online in the next few years than ever before. In the booming manufacturing hub of North Carolina alone, workforce development groups estimate that 8,000 additional biomanufacturing workers will be needed this year.

Building out a robust competency-based training system requires more upfront planning and concentrated effort. It will allow industry leaders to break out of the cycle that is costing valuable time, dollars, and resources and shift to building systems that can manufacture competence and long-term stability.

The Read and Understand Trap

The status quo training system has allowed for an illusion of compliance and understanding when in reality most training boils down to reading an SOP and signing a form to document comprehension and proficiency. While this creates a paper trail for each employee, no actual operational capability has been demonstrated.

Inadequate employee training is frequently cited as a top reason for receiving FDA Form 483 observations³ and warning letters during inspections. Rather than assessing and improving the current state, many organizations simply add more layers of paperwork to demonstrate activity and meet aggressive timelines for agency reporting. The standard solution implemented is more modules and signatures which only compound the problem and reinforce paper compliance over actual comprehension. Take aseptic gowning as an example. In many facilities an employee is formally qualified once, even though the task is performed repeatedly in high-risk environments.

In a high-stakes training approach often used across the Navy, continuous and multi-modal requalification is implemented. This ultimately ensures true operational understanding and capabilities.

Leveraging a High Stakes Training Approach

There are many adjacent industries that biopharma programs can model a successful and robust training program after. The Nuclear Navy Blueprint (NNPP) training models, developed by Admiral Hyman G. Rickover, implements a rigorous program with safety and strict technical oversight as pillars. The stringent program has a stellar performance record, operating 7,600 reactor-years without a reactor accident.⁴

While nuclear propulsion and pharma manufacturing operate in very different environments, both involve high-risk systems where operator competence directly impacts safety.

In the NNPP program, the qualification pipeline functions across three stages focusing first on fundamentals, then theory, before moving on to hands-on demonstration. The training program ensures personnel do not handle or interact with live reactors until competency is proven at each stage.

Transferable Principles for Biopharma

Many of these principles used in high-stakes training models can be implemented across the biopharma training processes.

Key success factors for developing and implementing a competency-based training program should include:

• Securing buy in from senior site leadership
• Ensuring sufficient financial support
• Assigning dedicated training resources to develop the program
• Leadership acceptance of the full training timeline required to achieve proficiency

Investing upfront in a well-designed competency-based training and qualification program reduces downstream errors and deviations. Every deviation triggers a resource‑intensive process involving write-ups, investigations, and multiple procedural reviews. While it takes more time and resources to implement a robust training system, it is far more efficient to do things correctly upfront than to expend significant effort correcting issues later.

Proper Training is a Leadership Challenge

The challenge of implementing a proficiency-based training program will be influencing large organizations to adopt new approaches, even when they are clearly beneficial. For established companies, it is often easier to continue with existing practices due to project timeline pressures. For earlier stage start-ups, this barrier is far lower, as these systems can be built correctly from the outset. To gain traction with larger pharma organizations we will need to draw on strong data and compelling case studies from other well-established, high-streaked industries.

While the solution sounds simple on paper, creating workforce scalability is only possible through culture change at the leadership level. Rickover’s standard encourages managers to design training as if your own family’s life depends on the operator’s competence. The fact is that someone’s family does depend on the quality of training and execution carried out in biopharma facilities. Keeping patients and their families in mind should serve as a driving force behind ensuring each training procedure is robust and that each operator is fully proficient. The models are proven but progress will depend on a systemic change and courageous patience from leadership teams to develop and implement a strong competency-based training program.

Sources

1. Cytiva, 2025 Global Biopharma Index (October 2025)
2. NCBiotech, Window on the Workplace 2023: Workforce Training Needs for North Carolina's Biopharma Manufacturing Industry. Supplemented by: Rewardian / LinkedIn Talent Insights data on life sciences voluntary turnover (2019)
3. ACG / FDA compliance analysis, "The Top 10 FDA 483 Observations and Strategies for Compliance" (2025); or FDA FY 2024 inspectional observation data directly
4. U.S. Department of Energy / National Nuclear Security Administration, The U.S. Naval Nuclear Propulsion Program 2025 (2025). Available at energy.gov.