John Milne, Training Director, National Institute for Bioprocessing Research and Training, and Anne-Cécile Potmans, General Manager, Fast Trak Services, Cytiva
As the biopharmaceutical industry continues to grow and expand, it increases the demand to develop a pool of skilled workers. Some bioprocessing positions can be difficult to fill, and those that are currently filled are at a constant risk due to competition in the market. Without routine training programs, your employees’ capabilities may not be strong enough to effectively execute on process development and manufacturing operations. This “skills gap” can slow down the progress of your molecule or even lead to costly batch errors. However, these skills are not easy to learn and master. How can you ensure that your staff is up to date on today’s complex bioprocessing techniques and technologies?
New era in biomanufacturing reshapes industry’s talent search
While monoclonal antibodies have proven themselves for many years as a therapeutic modality for a wide range of human diseases, a growing focus on niche drugs for smaller patient populations has created a tremendous amount of change in today’s industry. Spending billions of dollars on a large facility to manufacture one antibody is no longer a sustainable business model. Instead, pharma companies are looking to either recoup the costs of expired patents or expand their pipeline extraordinarily by dedicating resources and capital to establishing multi-product facilities. This business model can improve productivity and decrease costs, potentially helping lower drug prices in response to government pressure. Additionally, the drive to diversify pipelines as well as combating high failure rates in clinical trials have resulted in major mergers and acquisitions throughout the industry, as biomanufacturers look to improve their competitive advantage. These changes have resulted in exploration into new modalities that present complex processes and new challenges.
At the same time, this transition has also opened the door to opportunities for innovation in drug development and manufacturing. Facilities of the future offer lower capital costs and more efficient production by utilizing flexible and more automated technologies that facilitate product changeover, improve quality, and streamline operations. Yet, as companies try to implement more efficient approaches and technologies, they face a limited pool of talent equipped with the skills and experience to oversee these new processes.
As an example, one of the most challenging areas to fill is in technical support operations for both upstream and downstream manufacturing. Employees with these skills are essential to facilitate operations, as they can perform design and transfer processes, execute troubleshooting scenarios, and ideally should possess a working GMP knowledge. GMP knowledge is critical for those working in clinical or commercial manufacturing facilities, whether they work in frontline manufacturing or within the crucial quality assurance discipline. Regulators will always want to review GMP training records for any employee working in an environment where drugs are being made for clinical use. An appreciation of GMP is also essential for those working in process development disciplines, as they must be sure that the processes that they are developing are compatible with large-scale GMP requirements. These positions are typically filled by professionals with industry expertise and/or who come from a very high-performing academic background, often with PhDs. They are analytical in their mindsets and good at developing processes and identifying issues that could potentially pose serious problems later during production. Bioprocessing engineers also serve as crucial resources in a facility of the future, where automation will play a key role in connected processes and the increasing interest in digitization within future paperless facilities.
Employees who can adapt to the new paradigm of flexibility and agility in biomanufacturing will be the ones that companies target as the industry continues to evolve. The job an employee is doing and the manufacturing environment in which they operate may change dramatically over the next three to five years and certainly within their careers, so being able to adapt to new and unique challenges is a key attribute in current biopharma talent search initiatives. These factors and others will contribute to the need for a mobile, flexible workforce capable of making the journey into the unknown.
How do you know If you have a skills gap?
To identify whether you face a skills gap, you must look to your organization’s goals over the next two to three years. Are you bringing a new product in, and if so, are its manufacturing needs something your team is comfortable with and prepared to meet? If you have experts on-site with the appropriate skillset, a practical option could be to transition those resources into new roles and then backfill the open positions (depending on the existing programs you have as well as those in your product pipeline). However, if your team does not have the requisite skills, you will need to develop a strategy for training and/or upskilling personnel to build the additional skills within your team. You can also consider recruiting new personnel from the market with the appropriate skillset to fill current and future gaps.
Determining how much time you will need for training depends on how big of a leap you are taking from what you know to what you need to know. For example, transitioning from a stainless-steel environment to one utilizing single-use technology is not just a question of swapping out hardware – it calls for a very different type of process and mindset from production staff. Upskilling for this type of change could take anywhere from three to six months, depending on the existing skillset of your team, so you will need to plan accordingly in order to be ready on time. Before you begin training plans, though, you need to ensure your team has the time to participate and develop the skills they will need. You also need to make sure that, if you are taking resources from your frontline operations and moving them to a different area, you do not leave a hole that could impact the timeline of any existing products you are developing and manufacturing.
The impact of employee turnover
With so much movement in the industry, there is a great deal of opportunity to advance the future of your company and your team. However, there is also an increased risk of losing knowledgeable employees to your competitors, which can have a significant negative impact on your company and its bottom line in several ways. Employees not equipped with the appropriate expertise to execute modern-day process development and manufacturing operations could lack the skills necessary to troubleshoot issues and investigate deviations. Setbacks such as this can be detrimental to a commercialization timeline, as any delay or even a lost batch could potentially cost your organization millions of dollars.
Troubleshooting tasks do not just fall to one or two people, either. An entire team of experienced analytical, manufacturing, engineering, and quality experts is essential for ensuring the successful productivity of a plant, in order to deliver a product that meets regulatory standards. Securing the future of your company and its products depends on your ability to gain and keep the talent necessary to successfully manage day-to-day operations. Therefore, it is in your best interest to invest in your talent by offering them opportunities to develop other skills that could be part of their career development. Financial support for schooling or, at the very least, flexibility that offers them time to complete coursework is an option that fosters teamwork and relationship-building. It also strengthens company culture as one that strives to invest in and develop staff holistically, creating a sense of cohesiveness and building trust across the entire internal network.
Employees who feel valued are more likely to dedicate themselves to your cause and go the extra mile for the greater good of a company they believe in and that they feel believes in them as well. Retaining existing team members is especially important, as employees who have built a career in bioprocessing possess knowledge that comes only with years of experience. As companies look for ways to strengthen their place in the market, protecting the talent within your organization from being attracted by others is critical. This could mean offering strong incentives for them to stay, such as compensation or other added benefits. On-the-job training is another option, which allows them to continue to build their skillsets and career as well as their value within the company. However, this is not always possible due to constraints within the facility or access to equipment. Using programs delivered by universities ― or engaging with a third party on practical training in the laboratory or pilot plant environment ― are viable options to ensure the preparedness of both new and existing employees for new ventures in biopharma.1
Training strategies for you to consider
The power of training is immeasurable, especially when considering the cost of error in biomanufacturing. Thus, you should consider all training strategies currently available that will work with your long-term plans and timeline. A recent survey report sponsored by The National Institute for Bioprocessing Research and Training (NIBRT) and The Medicine Maker outlined current manufacturing practices and trends in biopharma, the opportunities and challenges these present, and the staff development necessary to meet the needs of the changing industry. As part of its findings, the report indicated that “an overwhelming number of respondents felt that on-the-job training (96%) and practical training in a lab and/or pilot plant environment (91%) were the most effective types of training.”
Short-term and online courses are increasingly popular options for investing in talent because they are easier to fit into already-overloaded schedules. Cytiva (formerly GE Healthcare Life Sciences) offers trainees to participate in Fast Trak centers across the globe. In these one- to three-day courses, trainees receive hands-on practice in troubleshooting-based scenarios and specialized bioprocessing techniques. These master classes provide a tangible learning experience for process development and manufacturing scientists that is relevant to their everyday work. For e-learning, NIBRT offers its NIBRT Online Academy (NOA), which includes a series of one-hour interactive lessons focused on all aspects of biopharma manufacturing. There is also an option to send employees to the NIBRT facility in Ireland: a purpose-built, multifunctional building intended to replicate a modern industry bioprocessing facility. It includes a bioprocessing pilot plant with extensive upstream, downstream, fill-finish, and analytical facilities, all operating in a realistic, GMP-simulated manufacturing environment.
While taking university classes is also an option, many of the courses taught today have not yet been updated to include training in newer areas such as cell and gene therapies. Nevertheless, graduates from these programs have built a strong enough foundation of knowledge to go to the next level of training with a third party, although this still requires a dedicated time period for learning. To help students prepare for the new landscape of biopharma, NIBRT has partnered directly with the collegiate sector in Ireland to offer programs that offer advanced and newer skillsets, allowing students to take NIBRT courses as part of their coursework. Biopharma companies can also help contribute to the future by communicating with academic institutions about the types of graduates and skillsets they need, or even organize meetings with students in their final year to talk about what their company does, what types of positions they want to fill, and the skills needed to do so.
Keep in mind that, regardless of the strategy you use, the talent you possess at your company will always be under scrutiny by regulators because it is the people and the processes they execute that ensure your products comply with GMP expectations. That is why you are obligated to train your staff, monitor the training’s effectiveness, and document all those efforts.
Taking proactive steps to equip your employees with the skills they need will help you succeed by furthering your ability to diversify your pipeline, get ahead of your competitors, and most importantly, bring high-quality drugs to the patients who depend on them.
1. NIBRT and The Medicine Maker (Texere Publishing). (February 2020). 2019-2020 Trends in Biopharma Manufacturing Survey Report. Retrieved from https://www.nibrt.ie/wp-content/uploads/2020/03/BT-Survey.pdf