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Organisational Structure Biotechnology Sector

Depending on the size and complexity of the Biotech company, there can be a mixture of the following Departments

  • Validation -Validates process, and equipment so that they are functional and in-line with business and regulatory requirements.
  • Research & Development (R&D):takes various forms, researching ideal formulations of drugs, researches improved analytical techniques or changes processes to optimise yield of product.
  • Process / Production -ensuring the Biotech process runs as it should, handling deviations and constantly monitoring conditions to ensure optimum yield of the product. Involved in all stages from upstream to downstream processing and purification.
  • Regulatory Affairs- management of the preparation and submission of regulatory documentation to the relevant government regulatory bodies - IMB, FDA etc. Maintenance of existing molecule applications and dossiers.
  • Quality Assurance(QA)- responsible for the development and management of quality systems within the department . The Qualified Person signs off on the batch (if it's a finished product facility), all associated documentation must be prepared by the QA Dept.
  • Quality Control(QC)- check incoming, in process and outgoing product quality using analytical techniques in the laboratory. Produce documentation for QA to support the batch release.
  • 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 Biotechnology. These supporting areas have been subject to a recent upturn recently, as companies are looking to consolidate and re-organise their business in various ways.
Bioprocess Engineer Academic Manufacturing and Technology Manager Engineering Regulatory Affairs Academic Automation Engineer Quality Assurance Officer Biopharmaceutical Pharmaceutical EU Process Engineer Contract Sales Development Executive Automation Software Controls Manager Project Manager Engineering Biochemist Senior Research and Development Scientist BD Manager Biotechnician Republic of Ireland Supply Chain Manager Senior Scientist Maintenance Technician Account Manager Formulation Scientist Dublin Connected Health Nurse Associate Planner Manufacturing Executive Chemist Scientific Medical Affairs Sligo Principal Scientist EHS Engineer Biomedical Engineer Quality Manager Chemistry Galway EHS Specialist QA Manager Scientist Limerick Supply Chain Regulatory Affairs Manager Clinical Research QA Analyst Dublin West QA Executive Biostatistician Validation Scientist Life Science Biotechnology Cork Research Scientist QA RA Engineer Validation Engineer Scientific Sales Electrical Engineer Dublin North R and D Manager Project Engineer Contract Biotechnologist Design Engineer Dublin South Engineering Manager Pharmacist MES Consultant Quality Specialist Healthcare Supply Chain Coordinator Equipment Engineer Quality Engineer Manufacturing Coordinator Manufacturing Engineer Quality Systems Lead Sales Consultant Sales Specialist Regulatory Affairs Specialist Formulation Chemist Production Supervisor QC Analyst Sales Executive QA Supervisor QA Specialist Senior Scientist PhD Research and Development Scientist Quality Assurance Medical Device Kildare Supply Chain Administrator Validation Coordinator Quality Auditor Westmeath Process Development Engineer Life Science Food Scientist Supply Chain Specialist Senior Research and Development Engineer Supply Chain Microbiology Maintenance Engineer Qualified Person