The Advantages of a Cross-Functional Staff Model in Pharmaceutical Manufacturing

Tommy BowlenIndustry, Manufacturing

CMO Cross-functional Staffing As a contract manufacturing organization (CMO), Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. It enables a CMO of our size to get the most significant value from each employee and to make each employee feel valued. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.

When an employee performs a wide range of manufacturing tasks, both in and beyond his or her comfort zone, there is less likelihood of burnout. A team member may be involved in a kitting run during the morning, and in the afternoon operating our robotic filling isolator. Team members, whether they have years of experience or are new, recently trained recruits, are expected to handle the full range of responsibilities. The kind of people most likely to succeed at a CMO will relish a role calling for that kind of versatility.

For the client, there’s reassurance in knowing that the individual formulating the product may be the same person who dispenses samples and does the filling and labeling for their product. That individual knows the product and processes from start to finish because he or she will have performed or at least seen the tasks at each stage of manufacturing. Beyond the manufacturing process, employees will know what the drug is for, what its characteristics are, and what its value is to the client and the client’s end user – the patient.

End to End Perspective

One of the advantages of contracting with a CMO that utilizes cross-functional staffing is that the people who interact with the product are attracted to and thrive in a multi-functional role.

Beyond merely being diligent and competent, an employee of a CMO tends to acquire an end to end perspective on manufacturing. That understanding translates into better quality control, and the ability to anticipate the downstream effects of any deviation from the documented process. Even in a carefully choreographed process like pharmaceutical manufacturing, unexpected things happen. An attentive cross-functional employee will know when to stop the process, and who to consult if an issue arises for which he or she doesn’t have firsthand expertise.

An employee responsible for multiple functions, is less likely to become distracted and lose focus. That individual is better prepared to catch seemingly innocuous anomalies before they become deviations or errors.

Over time, even standardized processes can change, sometimes in significant ways. An employee with a broad perspective is better able to adapt to those changes, and to appreciate how an upstream process change can affect downstream tasks. Also, a cross-trained team is more resilient, because it has redundancy to conduct the full range of manufacturing even if a key individual is unavailable.

Ideal candidates are hired for their advanced skills, manufacturing aptitude, and experience working in a regulated facility. Employees hired with more basic manufacturing experience typically begin in sampling/dispensing. Gradually, they enhance their skill set. Employees have opportunities to shadow team members before getting hands-on experience in a “sandbox” facility, where they can get practical experience with “training” product before performing these new tasks on a client’s drug.

Diverse Development Paths

An additional benefit for our team is that cross-training creates an array of career paths. Many new employees assume they will do the general work of manufacturing for several years and then move over to management roles, but not everyone has that inclination. Some want to move into quality roles, or project management, or business development, and many are satisfied to stay in operations, making and packaging drugs. Giving the employee a broad exposure to the entire spectrum of manufacturing functions increases the likelihood that the employee will make informed, realistic career choices, and managers will be able to give better feedback and advice while setting appropriate annual performance goals.

Contract manufacturing is a service industry. Once a drug arrives at a CMO, it becomes their responsibility for as long as it is on the premises. That pride of ownership mentality is what an effective manufacturing team member must embrace to be successful. At Singota, we expect our team members to the take initiative by broadening their competencies; our responsibility as managers of a cross-functional manufacturing model is to set them up for success.

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About the Author
Tommy Bowlen

Tommy Bowlen

Tommy is the Manufacturing Manager at Singota Solutions. He has over 10 years of experience in the pharmaceutical industry, with the duration of that time being spent in Manufacturing/Operations. His roles have ranged from Group Leader, Manufacturing Supervisor, Process Supervisor, Manufacturing Superintendent, to Manufacturing Manager. Tommy’s past employment was at a large Aseptic Filling CDMO and with the largest I.V. Bag production plant in the world. Tommy received his BA in History from Urbana University.