Addressing the skills gap in ATMP/CGT manufacturing

Developing Competency in the Advanced Therapy Medicinal Products (ATMP) sector - Part 2

Authors: Robert Hanna (Learning & Development Expert, GreenAscot Technologies), Craig Hasilo (Chief Scientific Officer - CellCAN)

In part 1 of this four part series, we shared insights into the evolution of training as a source of competitive advantage. But to have a precise and efficient approach to training, it requires a deep understanding of the competency to be exercised. This article will discuss the competency model and how it drives development and performance. 

Part 2 of 4 - Defining competency to drive development and performance

A competency model is an essential tool in understanding training gaps in a team, department, or an organisation. It breaks down the job role into the competencies required to do the work, assesses the frequency with which the activity needs to be performed, and is often tied to an approved curriculum. Formal competency models are not common in the ATMP sector, but they are gaining traction as they have demonstrated their reliability in many manufacturing environments.

A competency model makes expectations and accountability transparent

Investment of time and resources in a competency model is easily justified in large organisations with common standards, but faces challenges in cell and gene therapy environments because production lines tend to be unique - people, process, and equipment also vary widely, impacting the competencies required of HQPs. Adding the lack of standardised Cell & Gene Therapy (CGT) training, the role of the model is doubly important as it guides the selection and development of training programs. Conversely, once established, the production line’s competency model is likely to require fewer changes over the long term than in a larger multi-function organisation.


When guided by a well-structured model like the one depicted in Fig. 1, a combination of assessment tools allows an organisation to measure the required knowledge and observed behaviours of its people by role.1 Having assessed an HQP’s proficiency levels by competency, an individualised and fact-based training plan can be executed, and progress plotted. The competency model makes expectations and accountability transparent.

Fig. 1: US Department of Labor’s competency framework for the manufacturing sector

The combination of competency model and assessment tools are essential decision supports for the formulation of efficient training plans, but it is the training execution that presents new possibilities to a historic problem. The fundamental challenge with technical training for cell and gene therapy is the need to practise executing the designed manufacturing process away from the manufacturing – this points to a real need for a hands-on mock-up training room. It is a paradox that the great need for such facilities is only equaled by its scarcity.

Fig.2: For decades, NASA astronauts have used underwater
mock-up environments, allowing them to simulate
zero-gravity while performing immersive training.2

Competency models drive development

In the absence of an available mock-up GMP production line, proper training options are limited. Current methods can be accelerated through a detailed learning needs assessment, which can be produced once a competency model is established and associates are assessed individually and as a team. Minimum proficiency levels by competency are detailed for each job role according to operational requirements, and individuals can be assessed for the required knowledge and behaviours. The learning needs assessment is simply the expression of these gaps in proficiency and forms the basis of the organisation’s broader learning plan.

Close coordination between operations and training determines the minimum proficiency levels by job role, according to the current context, and therefore the training priorities. Some general subjects, such as qualification for GMP environments, can be outsourced off-site yielding the flexibility to send one or two learners at a time, while subjects for which there is a substantial amount of specificity to the operation must likely be conducted onsite (whether with an internal or external trainer).

There are important implications for an organisation that drives its people development with a competency model. Competencies and related proficiencies must be measured through a mixture of knowledge and behaviour assessments, and those tools and measures must be clearly aligned with operations; therefore one of the first operational implications is the work involved in shedding light on proficiency levels, and it is an uphill battle. Such assessments are not naturally welcome by staff as they will instinctively feel that it is an attempt to measure their worth – it is essential to sell them on the benefits it can have in terms of systematic skill and career progression.

 The role of the competency model is not to constrain, but to unleash potential and accelerate results.

The best time to develop a competency model is at the beginning of the implementation of the production process; ideally, it is also the best time to conduct a learning needs assessment. In these moments, there is a clear focus on the work to be done, how to do it, the tools and communication, dependencies, and the desired results.

In addition to assessing proficiencies, organisations can also assess their team members’ preferred learning styles3 – this simple step can significantly improve the return on training investment by enabling the delivery to be adapted for maximum impact. It also helps to retain talent and intellectual diversity by meeting all learners halfway.

Interactive Communication

Listening* to others and communicating articulately, fostering open communication. 
(Scale progression: increased complexity of messages, audiences and communication vehicles)

Level 1
Listens and clearly presents information

Level 2
Fosters two-way communication

Level 3
Adapts communication

Level 4
Communicates
complexe messages 
Level 5
Communicates strategically
  • Listens/pays attention actively and objectively.
  • Presents information and facts in a logical manner, using appropriate phrasing and vocabulary.
  • Shares information willingly and on a timely basis. 
  • Communicates honestly, respectfully, and sensitively.
  • Recalls others' main points and takes them into account in own communication.
  • Checks own understanding of others' communication (e.g. paraphrases, asks questions). 
  • Elicits comments or feedback on what has been said. 
  • Maintains continuous open and consistent communication with others. 
  • Tailors communication (e.g. content, style and medium) to diverse audiences.
  • Reads cues from diverse listeners to assess when and how to change planned communication approach to effectively deliver message. 
  • Communicates equally effectively at varied organizational levels. 
  • Understands others' underlying needs, motivations, emotions or concerns and communicates effectively despite the sensitivity of the situation. 
  • Communicates complex issues clearly and credibly with widely varied audiences. 
  • Handles difficult on-the-spot questions (e.g. from officials, interest groups, or the media). 
  • Overcomes resistance and secures support for ideas or initiatives through high impact communication. 
  • Scans the environment for key information and messages to form the development of communication strategies. 
  • Communicates strategically to achieve specific objectives (e.g. considers optimal "messaging" and timing of communication). 
  • Uses varied communication vehicles and opportunities to promote dialogue and develop shared understanding and consensus. 
  Entry Chemist
Working Chemist
 Managing Chemist  

Fig. 3: Interactive Communications competency definition for a Chemist.4

A competency model introduces science where art currently prevails, and along with it the assurance needed to foster predicable high performance on the production floor. Fundamentally, the role of such a model is not to constrain, but to unleash potential, accelerate results, and structure development plans. Further, it brings onboard the terms and measures to give that potential a clear expression, highlighting goals and steps along the way.

In part 3 of this four part series, we'll share some insights into how to make the best use of new learning technology.

In Part 4, we will discuss the training return on investment. Stay tuned! 

 

References: 

1 Employment and Training Administration United States Department of Labor, (April 2020), Advanced Manufacturing Competency Model, https://www.careeronestop.org/competencymodel/Info_Documents/Advanced-Manufacturing.pdf

2 The Atlantic, (November 6 2019), NASA’s Grueling Underwater Test for Astronauts, https://www.theatlantic.com/science/archive/2019/11/nasa-astronauts-spacewalking-pool/601375/

3 EducationPlanner.org, (2020), What's Your Learning Style? 20 Questions, http://www.educationplanner.org/students/self-assessments/learning-styles-quiz.shtml

4 Suzanne Simpson PhD, (23 September 2010), Competency Profile Example, https://en.wikipedia.org/wiki/File:Competency-profile.jpg#filelinks