Acknowledging the Biopharmaceutical Skills Gap
May 5, 2020
In this 4-part blog series, Hélène Pora, Vice President of Technical Communications & Regulatory Strategy at Pall Biotech, offers insight into one of the greatest challenges facing the biopharmaceutical industry today: employee training.
Part One: Acknowledging the Biopharmaceutical Skills Gap
An Evolving Market
In the past decade, the biopharmaceutical industry has expanded rapidly. Particularly within the gene therapy and viral vector manufacturing industry segment, we have seen a marked increase in advanced approaches to drug processing, creating new opportunities for hiring.
Unfortunately, growth and innovation across the industry have brought unexpected challenges. One of the most critical places has been in workforce training. It can be argued that some areas feel more pain than others, based on the volume of biopharmaceutical business being done there, but the effect is being felt globally. With existing employees, the challenge can often be that they have outdated methodology and/or knowledge bases, and for new employees it can be a lack of qualified candidates available to do the jobs.
Even when appropriate candidates are found, the challenge remains of how best to provide ongoing, real-time training that keeps them nimble and successful in their roles. There is also the need to meet current good manufacturing practice (cGMP) requirements in the operation of equipment. Particularly in the case of pursuing first-to-market strategies or addressing pandemic situations, flexible training programs that enable compliant operations are a necessity.
Cause and Effect
When recruiting new personnel at multiple sites, not least in emerging countries with language and cultural barriers, learning how to handle growing numbers of newcomers and transform on-boarding and compulsory cGMP operator training activities has become a very demanding exercise. In a 2016 biopharma-reporter.com State of the Industry survey, 60% of respondents reported that their companies were putting time into staffing, but there was not a complementary investment in training programs. With less resources put into training, the skills gap can only grow, and this has dire consequences.
The sector has exhibited recurrent issues in complying with existing requirements and regulations. Employee knowledge and training have been isolated as a key component of failing to comply with manufacturing regulations, which continue to evolve. Over the past decade there has been a broad increase in regulatory oversight, including stricter cGMP requirements, and a call for standardization across the industry. These challenges are all amplified by the level of process and technology innovation happening in areas that do not have existing talent pools.
Companies are struggling to get facilities up and running, while meeting compliance requirements. Within concentrated biopharm markets, companies are looking at new ways to approach recruitment. For established and new employees alike, it is crucial to leverage the skill sets that exist and complement them with training and continuous learning about how modern biopharma manufacturing is done.
Training for Success
Across the world, technology is playing a more critical role in the future of various industries, and the biopharmaceutical sector is no different. However, because the industry is so regulated, we see a greater focus on ongoing training programs that enable staff to have secure access to initial training and continued real-time education that affect their job today and going forward.
At Pall we align with customers to empower staff with compliance and safety focused equipment operations training and continued education that ensure success.
Join us next week, as we dig into Part Two: Industry Training Challenges to learn more about the specific challenges being faced in closing the skills gap.
View the Biotech regulatory support portal.
Hélène Pora – Vice President, Technical Communication and Regulatory Strategy
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