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Biopharmaceutical Sector Organisational Structure

In generally the industry is broken down into a number of specific subsectors or departments.

  • Validation & Compliance - Involved in the validation of equipment and processes on the manufacturing site to ensure they comply with regulations and that they perform their specified functions.
  • Research & Development (R&D) - Involved in the research of new products and the development of processes to facilitate the scalable manufacture of these products. Also process development / analytical development which aims to optimise manufacturing conditions to ensure optimum yield and the analytical processes to ensure accuracy.
  • Process & Production - Involved in the actual manufacture of the product and the control of the manufacturing environment. In biopharmaceuticals the process is defined with upstream processing, downstream processing, purification, sterilisation and fill-finish.
  • Regulatory Affairs - Preparation and submission of regulatory documentation to the relevant government regulatory bodies - IMB, FDA etc.
  • Quality Assurance (QA) - Responsible for the development and management of quality systems.
  • Quality Control (QC) - Check incoming, in process and outgoing product quality using analytical techniques in the laboratory. Produce documentation for QA.
  • Supporting Functions - depending on the company and their level of involvement in Ireland, other functions can range from HR to Supply Chain, Technical Services, Finance and Sales and Marketing.