Identifying and Addressing Workforce Skill Gaps in ATMP Manufacturing

Identifying and Addressing Workforce Skill Gaps in ATMP Manufacturing

A Summary of Research

Prepared by Shada Warreth 

Background: Talent as a Key Predictor of Success

Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, are transforming the treatment landscape for many previously incurable diseases. However, the rapid growth and increasing complexity of these therapies are placing unprecedented demands on the biopharma workforce. Globally and nationally, industry reports have identified talent as one of the most significant constraints to sector growth, with persistent shortages in advanced modalities, digital manufacturing, and quality-focused roles. Recent NIBRT research, conducted by Shada Warreth, aimed to investigate these workforce gaps within the industry. The research, conducted between June 2023 and January 2024, surveyed 40 professionals across the ATMP value chain, including manufacturing, regulation, education, supply chain, clinical trials, and technology. 

Survey Results : A Need for Change

The survey revealed ninety percent of respondents agreed that a significant shortage of skilled personnel existed in ATMP manufacturing, with recruitment and retention hindered by difficulty sourcing experienced candidates, limited access to training, uncompetitive salaries, and poor recognition of transferable skills. Participants also highlighted unrealistic job specifications, short-term contracts, lack of structured graduate schemes, and limited awareness of ATMP careers within universities as contributing factors

The research also suggests the most critical functional areas of shortage are quality assurance and control (QA/QC), manufacturing and process development, and regulatory affairs, alongside gaps in contamination control, sterility assurance, and quality risk management. In their responses, participants emphasised the need for a diverse talent pipeline incorporating graduates, apprenticeships, and experienced professionals from related bioprocessing sectors.

Three broad skill domains were considered essential in ATMP Manufacturing. These were theoretical knowledge, technical skills such as aseptic processing and GMP, and transversal skills including teamwork, problem-solving, critical thinking, and adaptability. Aseptic processing emerged as the most deficient area overall, followed by automation and digital manufacturing, bioinformatics, and mathematical/data analysis. 

Skills Heatmap - Skill areas with the lowest demand (score <5) are marked in green, those with moderate need (score 5–10) appear in yellow, and the most critically needed skills (score >10) are highlighted in red.

Research Outcomes and Implications 

A key outcome of the research was the development of a new microcredential, the Certificate in Advanced Therapy Medicinal Products Development and Manufacturing, created through collaboration between the NIBRT Global Qualifications project and ATU Sligo. The programme was designed to address high-priority technical and transversal skills through flexible, industry-aligned training. Shada's research proposes that data-informed workforce development initiatives will be essential to building a future-ready ATMP manufacturing workforce. 

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