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Company Organisational Structure

The Structure & Departments of a Pharmaceutical Company

Production (Manufacturing)

Deal with all stages of pharmaceutical product manufacture – from producing active ingredients, through to completion of finished products and even packaging. Due to this diversity, work in this area can take many forms and involve the use of specialist machinery. These production processes are all carried out in strict adherence to both internal and external protocols.

Typical % of total company employment: 50%

Breakdown of department activities in Biopharmaceutical manufacturing:

  • Upstream & Downstream activities –
    • Upstream activities are stages of biopharmaceutical processing up to the cell-culture or fermentation process that is used to make the target proteins.
    • Downstream activities are the stages of processing that come after cell culture or fermentation. These stages include separation and purification to achieve the required drug product
    • Averages 30% of total company employment (in a new plant the number will start low and increase as activities are scaled up through to full production)
    • Generally engineers, scientists and technicians with Honours Degree and Masters level qualifications
    • In Ireland, this is equivalent to NFQ level 8/9
  • Manufacturing, Science & Technology (MSAT)
    • Supports operations with activities such as continuous process improvement, implementing new technologies and troubleshooting.
    • Average 10% of total company employment.
    • Typically engineers, scientists and technicians with Ordinary Degree and Honours Degree level qualifications
    • In Ireland, this is equivalent to NFQ level 7/8
  • Fill Finish/Packaging –
    • Some of the final stages of the manufacture process where the active agent is prepared into its final form, before being filled and sealed within containers.
    • Average 10% of total company employment once at full production.
    • Usually requiring Ordinary or Honours Degree level qualifications but some Diploma level qualifications with relevant experience may be suitable
    • In Ireland, this is equivalent to NFQ level 7/8+ (or level 6 with experience)

Skills needed include:

  • Good manufacturing practice
  • Aseptic and sterile manufacturing
  • Upstream processing
  • Cell culture
  • Downstream processing
  • Drug substance production
  • Media and buffer preparation
  • Viral clearance
  • Lean Six Sigma manufacturing

Quality (including Validation)

Functional area that monitors and documents activities, processes and products of manufacturing to ensure they meet strict standards and predefined expectations. Ultimately, this team ensures the safety of the drugs that go out for distribution – their activities are essential within such a regulated industry.

Typical % of total company employment: 30%

Breakdown of department activities includes:

  • Quality Assurance – monitors and test processes to ensure results fall within predetermined ranges
  • Quality Control – tests products of manufacturing process to ensure meets predefined criteria
  • Validation – creates an evidence trail to show a process or system leads to a consistent result that can be reproduced

Skills needed include:

  • Good lab practice
  • Molecular biology
  • Protein characterisation
  • Bioanalytics
  • Biochemistry
  • Protein chemistry
  • Glycan analysis
  • Microbiology
  • Ultra performance liquid technology/ultra high performance liquid technology (UPLC/HPLC)
  • Bioassays
  • Mass spectrometry
  • Documentation management
  • Batch release
  • Regulatory filings

Operations

Ensures the continuous functioning of the manufacturing plant and its equipment.

Typical % of total company employment: 10%

Breakdown of department activities includes:

  • Technical Services –
    • Average 6% of total company employment – numbers increase as plant scales up to full production
    • Generally workers will have a minimum of an Ordinary Degree level qualification alongside relevant experience. Employees with a Diploma level craft qualification may be suitable for upskilling
    • In Ireland, this is equivalent to minimum NFQ level 7 qualification and relevant experience, with NFQ level 6 craft qualification holders having potential for upskilling
  • IT/Automation –
    • Average 4% of total company employment during full production
    • For roles here, typically an Ordinary Degree level qualification is required
    • In Ireland, this is equivalent to NFQ level 7 qualifications

Skills needed include:

  • Facility management
  • Equipment maintenance
  • Clean utilities
  • Calibration
  • Automation

Research & Development

Where staff are engaged in making improvements and modifications to existing production processes and identifying possible new production technologies and applications.

Typical % of total company employment: 5%

Department requirements:

  • May be located within the facility or at a centralised company location
  • Typically requires a minimum of Honours Degree qualification alongside experience
  • Averages 30% of total company employment (in a new plant the number will start low and increase as activities are scaled up through to full production)
  • In Ireland, this is equivalent to NFQ level 8/9/10 qualifications with experience

Skills needed include:

  • Varies depending on products and areas targeting for product improvement

Other

Includes areas such as Supply Chain, Logistics, Marketing, HR, Warehouse, Finance, etc.

Typical % of total company employment: 10%

Breakdown of department activities includes:

  • May be located within the facility or at a centralised company location
  • Typically requires Ordinary or Honours Degree level qualification with domain-specific knowledge. Warehouse roles may be suitable for those with Diploma qualifications and appropriate upskilling
  • In Ireland, this is equivalent to NFQ level 7/8+ qualifications with domain-specific knowledge. While level 6 qualification holders may be appropriate for upskilling for warehouse roles

Skills needed include:

  • Good distribution practice
  • Project management
  • Production planning
  • Procurement
  • Stock management
  • Distribution
  • Warehousing

One thing to keep in mind is that this is just a guide. The size of these departments ultimately depend upon the size of the pharmaceutical company (smaller companies may outsource some of these roles altogether), but they are all ultimately critical parts of the pharmaceutical manufacturing process.

For more information on specific job roles, check out this page.