Cell Manufacturing Competency/Proficiency FAQs
With the dramatic development of the cell therapy field over the past decade, the ability to hire, train and assess a team is critical to GMP success. In the FAQs below, representatives from the CPCI cGMP Working Group share their thoughts on best practices.
Hiring & Retention
Cell Manufacturing Hiring & Retention
What background and experience, both level and type, do you look for?
There are a variety of approaches to building biomanufacturing teams, and they are driven, in part, by the facility certification and the types of work being performed. Many of these roles can be trained for and each of our institutions are positioned to provide extensive training, allowing us to consider candidates with varying levels of education, from those with a high school diploma to those with a PhD. Hands-on experience in the lab or blood banking-environment is much more common. Some roles such as Quality Assurance lend themselves to candidates with prior industry experience. Some institutions make use of med techs with hospital experience, in addition to or in place of team members with research backgrounds and find that their experience with regulated work and the standard of care practices can help to accelerate their training.
“We prefer to hire entry level technicians. Due to the specialization, finding experienced technicians is difficult. We end up paying more for experience that is not relevant to our department”
Do you have a career ladder and, if so, what does progression look like?
All members of the working group are in the process of developing and expanding internal career ladders to aid in retention and growth within their teams. This effort is especially critical as many sites are located in regions where they must compete with biotech companies for talented workers.
In these ladders, many sites have developed pathways for individual-contributor advancement, separate from traditional promotion into management roles. While all team members want to grow in their careers, they should not be limited by the requirements of a managerial track including number of reports, number of the management roles or their lack of desire to grow by managing others.
From experience, we know that the unique nature of GMP work may not fit well into existing institutional HR job codes and so it is important to develop new job codes and roles, separate from the traditional Research Associate/Research Scientist pathway. This effort often requires hiring managers to work closely with HR so that they better understand the GMP’s needs as well as creatively adapting existing job titles. This allows benchmarking against industry-equivalent positions and responsibilities.
Do you have an issue with retention?
The rapidly growing biotech sector poses a challenge for retention, as comparable roles may pay more and provide additional opportunities for career development. This underscores the importance of having well-thought-out career ladders.
In addition, we know that the academic setting provides many enrichment opportunities a commercial setting cannot, and it is incumbent upon mangers to highlight and offer those opportunities. Engagement examples might include publication authorship, participation in facility tours or patient/media visits or delivery of product to a patient’s bedside. The working group has found that any activity which helps connect team members more personally to the outcomes of the manufactured products is powerful.
For further thoughts on retention, please read this white paper with retention suggestions:
CPCI cGMP Working Group: Retention ReportTraining
Cell Manufacturing Training
Are your roles highly specialized or do you cross-train and why?
Cross-training is regularly performed within standard functional groups like Quality Assurance, Quality Control and Manufacturing but less commonly across those groups, as some boundaries need to remain in order to meet GMP requirements.
The working group has found cross-training beneficial for many reasons. It is linked to retention as it provides team members with the opportunity to broaden their skills. In addition, many of our teams are small and cross-training allows us to level load work and provide coverage in times of staffing fluctuations.
How long does training take for new hires?
While there is variability across the sites, it takes about four to six months before new team members can contribute significantly. For less common processes, such as those that may only occur once or twice a year, it can take up to 12 months because of lack of exposure to the process and the cost of executing processes solely for training processes. The experience of the incoming team member and the bandwidth of the team to train can have an impact on this time frame.
We have found that there is a value to staged training approach. Using this approach, a team member may complete training on one procedure and be signed off to operate, while still undergoing training on the other processes specific to their role, rather than all-or-nothing skill acquisition where an operator is not signed off to operate until they have completed training on all role specific procedures. While the staged training approach can extend the overall training timeline, it allows new team members to contribute earlier by taking some limited tasks from more senior team members. Such an approach also improves engagement by allowing team members to contribute earlier to the team’s operations.
Training often begins organically and evolves into a standardized training program with milestones for completion as the team grows. The benefits of a more standardized program include clear communication of training process flow and trainer/trainee responsibilities. Refinement of such a program is only gained through learning from trainer and trainee experiences and so is difficult to develop without ongoing hiring and growth.
Does experience impact training length?
It depends. If the incoming team member’s experience is highly relevant that experience can speed up the training process. Many of the requirements of GMP operation remain consistent across site, but there are site-specific difference in execution that require training effort for even experienced team members. At least one site has found that they needed to untrain an experienced hire and so the training actually proceeded more slowly than anticipated, as habits needed to be corrected or changed. Regardless of the background of the new hire, the training system should have built-in flexibility.
Who conducts training: Dedicated trainers? Managers? Quality Assurance team members?
Responsibility for conducting training is highly variable across the working group sties. Some sites encourage trained team members to opt-in if interested in taking on this extra responsibility, while others delegate training responsibilities to work area leaders or senior techs. It can be challenging to get institutional buy-in for the need for dedicated, or full-time, trainers/training team but this becomes increasingly important in order to build standardization as a team grows.
For manufacturing, is there a difference in training for the operator vs verifier roles?
In general, while the same overall training is necessary, there are mixed preferences with respect to whether newly trained team members should move into an operator or verifier role first, following training completion. Preference is in part dictated by the size of the team, and the frequency and complexity of the processes in question. In some cases, to broaden bandwidth of the processing team, supervisors or Quality Assurance are permitted perform some verifications (label preparation, calculations, etc.) in place of fully trained processing team members.
Assignment of team members to particular processes and/or trials must be assessed based on the business needs of the team. Factors impacting this decision include capacity, accrual rate, budgetary constraints, process complexity, overlap between similar processes, and the like. It is important to ensure sufficient trained team members exist to meet projected “surge” capacity, and/or to have a plan in place for rapid cross-training, if needed. In our opinion, allowing members to engage in multiple processes has a positive impact on team engagement.
Who decides what level of training is required, i.e. read-only vs full training?
The training level should be decided in collaboration between the leaders of the functional group and quality team. In general, minor process or policy changes may require only review of the relevant document, while larger changes or brand-new processes need hands-on training. Full training requires that the trainee has read and understood the procedure, observed the procedure and demonstrated, under supervision, the ability to perform the task independently. Read-only training requires that the trainee has read and understood the procedure/policy but does not require demonstration of performance to do that procedure/policy prior to sign-off. It is important for leaders and quality to consider process complexity, business needs and prior experience of the trainee in deciding what level of training is required.
Is prior experience considered when determining required training?
Prior experience should be considered on a case-by-case basis by functional group leadership and the quality team. While the opportunity exists to accelerate training based on the experience of the trainee, there should generally be no level of experience that would allow someone to skip training.
How is prior experience documented if it is considered for completion of required training?
How prior experience is documented depends on the documentation policies of the group but should be intentionally documented, internally consistent and reviewed by leadership and Quality Assurance. For example, training forms could be created with space to document prior experience, or a memo could be written to the file, reviewed, and stored in the training record.
How standardized is required training across members of the team?
Training should be standardized by job code or role.
Assessment
Cell Manufacturing Assessment
It is generally not feasible to assess all processes for manufacturing. Instead, we recommend selecting representative processes that are either common between multiple processes, frequently performed, or particularly difficult, and using these processes as indicators. For Quality Control proficiency on analytical tests, it may be more reasonable to assess all assays.
“Competency is assessed by performing two procedures under review. One procedure should include aseptic technique. The two procedures assessed shall be different than those chose the previous year.”
Many options exist. Some level of direct observation or hands-on assessment is necessary in order to ensure processing skills remain sharp and tasks can be performed successfully. Written tests can also be useful to assess understanding of policy. Further, analysis of deviations and process outcomes are also a possibility as they can shed light on common issues experienced by multiple team members, implying the need for process changes. For Quality Control assays, external specimens with known values, for example CAP specimens, may be a useful tool.
Who assesses competency of the team/team members?
The responsibility for assessment is split between peer/supervisor and Quality Assurance, as appropriate.
What are the consequences for failing to demonstrate competency?
Generally, the working group members view failure to demonstrate competency as an opportunity for ongoing education that can be accomplished with retraining and counseling/coaching. However, depending on the severity of the observation, elevated corrective action may be indicated, up to and including separation of employment.