1. Analysis of Skills Needs in Life Sciences Merseyside and Halton

2. Study commissioned by MerseyBIO on behalf of the Partners Pye Tait Ltd were contracted to undertake survey Steering Group –Ensured the focus of the work had an industry perspective. Chaired by Steve Jones, Novartis Vaccines Questionnaire Design –Design was driven by industry expertise MerseyBIO Network –Using our network, we have achieved a very high response rate Management of the Study

3. 46.9 21.9 9.3 Diagnostics R&D Consultancy Manufacturing Diagnostics * Managing an inventory * Ensuring equipment is cleaned * Monitoring competence of staff * Keeping financial records where required Manufacturing * Setting up equipment * Solving packaging problems * Contributing to standard operating procedures * Setting up procedures for ensuring manufacturing adheres to regulations Consultancy * Capacity management * Testing operations * Drawing up principles for dealing with the supply chain * Providing advice and support for implementation of quality systems R & D * Following the relevant process instructions * Writing technical reports * Ensuring own actions protect the environment * Setting up systems for managing quality Types of skills employed in our industry in Greater Merseyside

4. Sector Drivers

5. Aims of study Obtain detailed map of skills requirements to meet the demand of this growing sector Gain in depth understanding of manufacturing and related skills Inform key partners/stake holders on creating demand- led program of training for the industry Use the findings to develop a Local Skills Agreement for training –to ensure funding agencies are aligned with industry requirements

6. Methodology

7. Setting the scene – initial information gathering Desk research – existing detail on skill needs analysed to develop survey structure Telephone discussions with training providers to establish current specialist training provision Face-to-face interviews and telephone interviews Steering group review and input supported by industry specialists

8. Structure of survey Operators 98 skills assessed Supervisors 51 skills assessed Managers29 skills assessed Identified skills for analysis were exclusively based upon technical skill requirements Managers were asked to comment on the level of competence of their staff relating to the skills defined in the survey Managers were also asked to comment upon their view of the future relevance of skills

9. Survey Coverage 42.8% of companies in Greater Merseyside interviewed 2895 employees were represented in this survey Mixture of operational, managerial and technical staff job roles represented

10. Scoring & Presentation of Results Managers marked skills between 1 -10 10 represented perfect, requiring no attention 1 represented poor skill, requiring attention 7 represented a skill that meets business requirements, and therefore considered satisfactory Therefore, scores below 7 are defined skills gaps in the industry, and those considered to be of future importance as actionable

11. Data Processing

12. Areas were split into three major business sections for –Operational/Frontline staff98 skills assessed –Technical/Supervisory Staff51 skills assessed –Managerial Staff29 skills assessed Each skill was rated for current importance and future importance to the respondent company The mean scores across all respondents for a particular skill were calculated. These results are the basis of the presentation and have identified skills gaps in the current activities required within companies, as well as skills gaps for the future of our sector.

13. Data Processing To simplify the identification of the areas of skills shortage, or future gaps, the processed data were plotted on to scatter diagrams. To ensure consistency of visualisation and allow comparison of the three types of role, scores were normalised relative to the mean score for each group.

14. Current skill Levels are low. Skills rated highly for future importance Example Scatter Diagram Equivalent to a score of 7.00 Staff currently Highly skilled. Skills not rated highly for future importance Staff currently Highly skilled. Skills rated highly for future importance Current skill Levels are low. Skills not rated highly for future importance

15. Results

16. Results identifying actionable Skills gaps for front line/operational staff Normalised mean score Skill score of 7.00

17. PreparationControlCompletion Resource management Segregating materials Operating/setting up automated inspections Setting up automated systems to conduct validation Control of inventory/stock Cleaning equipment Testing operations Testing materials Protein separation Fermentation Incubating a virus Harvesting a virus Potential inactivation of a virus Controlling process automation Operating/setting up automated inspections Conducting checks against GMP Control of inventory/stock Separating/disposing of processing materials, by products and waste Cleaning equipment Identified Skills Gaps Operational/Frontline Staff

18. Results Identifying Actionable Skills Gaps for Technical/Supervisory Staff Skill score of 7.00

19. Identified Skills Gaps Technical/ Supervisory Staff PersonnelProcess, Data & Validation Other Responding to poor performance in the team Identifying skills needs of staff Assessing effectiveness of personnel in validating equipment & environment Validation Setting parameters for process validation Define which processes that impact on validation Planning timescales for revalidation Solving packaging problems Writing technical reports Understanding environmental considerations in packaging Process & Data Understanding and use of Statistical Process Control (SPC) Monitoring use of SPC techniques during routine production Putting processes in place for collecting data during routine production Collecting data during routine production Monitoring data

20. Results Identifying Actionable Skills Gaps for Managerial Staff Skill score of 7.00

21. Identified Skills Gaps Managerial Staff Measuring line efficiency and improving Operational Equipment Efficiency Borderline Skills Gaps - Understanding the legislation regarding waste routes & environmental impact. - Understanding potential hazards with airflow and filter sizes.

22. Cross cutting themes Those skills that underpin all elements of dealing with supply chain, R&D as well as manufacturing Cross-Cutting Themes Setting up automated systems to conduct validation Executing validation protocols Testing of filters for validation Operating/setting up automated inspections Controlling process automation Understanding of how to monitor/analyse efficiency of equipment Understanding of relevant GMP (secondary manufacture) Understanding of how to classify materials according to GMP Complying with FDA requirements for GMP Understanding of FDA requirements, Material Resources Planning Carrying out environmental monitoring – air, water and surface sampling Awareness of European guidelines about distribution and CE marking Conducting checks against GLP/GCP (R&D) These are skills required across all levels of staff

23. Summary

24. All skills summary

25. Identified Skills for Action Level of staff Actionable Skills Borderline Skills TOTAL gaps Number% % % ALL skills Front line/operational (98 Skills) 1717.31616.33333.7 Technical/supervisory (51 Skills) 1531.347.81937.3 Managerial (29 Skills) 13.42 310.3

26. Prioritised Actionable Skills Process Front line/operationalSupervisoryManagerial Process automation and Statistical Process Control (SPC) Setting up and operating automated inspections Controlling process automation Understanding use of SPC Monitoring use of SPC techniques Reviewing process effectiveness Understanding of how to monitor/analyse efficiency of equipment Collecting data during routine production Monitoring data Identifying and reviewing skills needs of staff Identifying skills needs of staff Assessing effectiveness of personnel in validating equipment and environment Responding to poor performance in the team

27. Prioritised Actionable Skills Quality Front line/operationalSupervisoryManagerial Environmental considerations Carrying out environmental monitoring – air, water and surface sampling Understanding environmental considerations in packaging

28. Prioritised Actionable Skills Regulation Front line/operationalSupervisoryManagerial Understanding of relevant GMP in secondary manufacture and conducting checks against this Understanding of relevant GMP Conducting checks against GMP Complying with FDA requirements for GMP Validation Executing validation protocols Testing of filters for validation Assessing effectiveness of personnel in validating equipment and environment Setting the parameters for process validation In-house inspection Operating/setting up automated inspections Inspecting machinery provided by third parties

29. Current use of Training Just under one quarter of companies prioritise training that will impact on adherence to regulations (eg: GMP and GLP) Tend not to use structured training plans but send staff on provision when need arises Most frequently accessed training (>10% of training) delivered either in-house or externally was related to quality, regulation and technical skills used in R&D and primary manufacture Barriers: cost of training; time and money lost in releasing staff; and lack of information on specialist training available 22% of companies have also sourced management development training from external providers

30. Summary Sector diverse – range of service and products and stages of development of companies Despite this – cross-cutting themes affecting everyone All levels frontline/operational, technical/supervisory and management staff have some gaps Highlighted are regulation process and quality Largest percentage gap reported in skill levels – technical/supervisory staff Frontline/Operational staff demonstrated largest number of skills gaps Current training provision is not readily available across the sector in the areas of: –Process of automation –use of SPC –Technical report writing –environmental requirements –in-house auditing