Education and Training in Pharma
Company Organisational Structure
The Structure & Departments in a Pharmaceutical Company

The Structure & Departments in a Pharmaceutical Company

Pharmaceutical Manufacturing is the synthesis and manufacture of medicines on an industrial scale in a pharmaceutical manufacturing plant. Here is a quick overview of the departments typically found within a (bio) pharmaceutical factory:

  • Production (Manufacturing) – (approx 50% of staff)
  • Quality ( Including QA and QC, Validation and Reg Affairs) (approx 30% of staff)
  • Operations – includes areas such as maintenance, HVAC, Automation & Control, Building Services. (approx 10% of staff)
  • Research & Development – (0% to 5% of staff)
  • Other – includes areas such as Supply Chain, Logistics, Marketing, HR, Warehouse, Finance, etc. (approx 5% of staff)

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

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

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

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 – focuses on eliminating process variation by creating, revising and strictly implementing a set of tightly and precisely defined process/procedures/checklists/quality system standards that when exactly followed, ensure the final quality of the product. Quality Assurance is preventative by nature and makes sure you are doing it “Right First Time”.
  • Quality Control – is product oriented and focuses on testing a sample of the final product of a manufacturing process to make sure that is meets the required design specifications or quality standards. Testing for quality can be done with a 100% sampling or with a small sample using techniques like statistical process control (SPC).
  • Validation – creates an evidence trail to show a process or system leads to a consistent result that can be reproduced
  • Regulatory Affairs – deal with the applications and paperwork surrounding regulations that have to be done before a medicine can be sold to the public

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

Technical service covers areas such as maintaining the building infrastructure, facility management, equipment and electrical maintenance, instrumentation and calibration, HVAC (heating, ventilation and air conditioning) to ensure a sterile cleanroom atmosphere, providing clean utilities such as steam, water and compressed air.

  • 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

IT.Automation & Control

Covers areas such as information technology, multiple system integration, using automation and control (installing, programming and maintaining PLCs) to oversee or manage the manufacturing process and streamline it to make it as efficient as possible.

  • Average 4% of total company employment during full production
  • For roles here, typically an Ordinary Degree level qualification is required

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)

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

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.

Want to Know More About Careers in Pharma Industry?

Check out 5 Reasons to Choose a Pharmaceutical Career for an in-depth look at pharmaceutical manufacturing as an industry.

Explore these Pharmaceutical Job Descriptions and Salaries to see the types of jobs you could be suitable for.

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Company Organisational Structure
  • Pharma Manufacturing Jobs are Stable, Safe and Secure
  • 81% of 2017 Graduates Found a New Job in 6 Months
  • High-Paying Jobs – 30% Above Average
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