The industry is moving so rapidly that regulatory agencies are having to scramble to ensure it has adequate expertise on the advanced therapeutics arriving through the pipeline.
In its forward plan to 2025, the European Medicines Agency stated that it needs to facilitate the implementation of novel manufacture technologies, which would, in turn, require the further recruitment of those with expertise in such areas.
The industry itself is not immune to such pressures, with one person involved in the cell and gene therapy space in the UK telling us that the number of experts in the manufacturing space needs to double in the next five years to meet demand.
BioPharma-Reporter (BPR) spoke to Jonathan Woolliss (JW), external training lead at Zenith Technologies, to gain insight into how companies can adapt to the evolving expertise needs of the industry and how to effectively train existing staff.
BPR: Why is there such a challenge in keeping the workforce educated in line with the demands of manufacturing in the industry?
JW: One key area that is challenging the industry is the continued growth of biopharmaceuticals. The industry has experienced rapid expansion over the last three decades – biopharmaceuticals now make up more than 25% of the total pharmaceutical market.
When the industry first emerged, highly skilled bioprocessing chemists were running facilities and developing capabilities for the whole industry. In the years since, the number of biopharma facilities has increased along with the rising success of monoclonal antibody (mAb) products. This has resulted in a growing demand for operators, however their starting skill level has decreased, which means the industry is looking for ways to upskill individuals at a quicker pace, so that they can effectively run biopharmaceutical facilities.
Due to the vital responsibilities involved in an operator role, it is important that effective training strategies are provided for individuals to help prevent batches being rendered unfit for use should control system errors occur.
BPR: What is being done to keep the workforce educated to the appropriate degree?
JW: There are regulatory controls and commercial requirements that ensure employers are training their workforce adequately and helping them progress. Volume 4 of ‘The Rules of Governing Medicinal Products in The European Union’ states that “newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed.” In short, manufacturers have to train their personnel and operators effectively in order to meet good manufacturing practice (GMP) standards,
To this end, adaptations to traditional training methods have been made across the industry. Measures to review progress periodically and deliver refresher training are now the norm. We are also seeing the adoption of updated training methods and materials that are more representative of each business’ dynamic nature, rather than the generic classroom and ‘read and understand’ training traditionally delivered in the industry.
Ultimately, it is essential that companies employ new training approaches to combat the issues arising from the industry’s skills gap.
BPR: The biopharma space continues to expand and develop rapidly – what can companies do to ensure that they keep pace with change?
JW: As it currently stands, the expansion of the biopharma space has brought new training challenges. Companies should seek to understand the training needs of new or potential operators to provide modern learning strategies that match their requirements, as opposed to offering generic development programs. They should also consider adult learning preferences, and make it role-specific and interactive where possible.
Adults are keen to learn experientially; customizing training strategies means companies can ensure they are keeping up with the pace of industry advancements and allow users to emulate real-life scenarios in a more authentic experience. Creating a ‘real’ learning environment enables operators to visualize their workspace and develop the skills needed to efficiently handle equipment and manage any potential issues.
At Zenith, we collaborate with customers to develop content and create a training manual and virtual training environment. The virtual training environment is based upon actual operating practices and control system technology in their work environment to ensure individuals are learning about realistic workflows and sequences. Using modern technology tools, such as augmented reality, enables companies to provide up-to-date training for each end user, which is both a customized and cost-effective training solution.
BPR: With a limited pool of talents, how does a company proactively retain its workforce?
JW: Generally, companies stand a better chance at retaining staff members if they invest in their personal development within the organization. Without progression opportunities, individuals are highly likely to lack motivation in the workplace and may source alternative roles.