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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.
Supply Chain Administrator Regulatory Affairs Scientific Biotechnology Dublin West R and D Manager Supply Chain Analyst Supply Chain Coordinator Biotechnician Electrical Engineer Galway Biopharmaceutical Regulatory Affairs QA Specialist Academic Dublin South Manufacturing Coordinator Supply Chain Contract Quality Assurance Officer QC Microbiology Analyst Engineering Supply Chain Specialist Quality Assurance Offaly Connected Health Principal Scientist Research Scientist Biochemist Regulatory Affairs Manager Kildare Supply Chain QA Manager Microbiology Supply Chain Manager EHS Engineer Planner Limerick Cork Formulation Chemist Quality Control Manager Process Engineer Senior Scientist Manufacturing and Technology Manager Biostatistician Engineering Manager BD Manager Chemistry EHS Specialist Regulatory Affairs Specialist Clinical Research Sligo Automation Engineer PhD Quality Specialist Academic Scientist Research and Development Scientist Manufacturing Engineer QA Analyst Formulation Scientist QA Supervisor QA Executive Quality Systems Lead Sales Executive Validation Engineer Pharmaceutical Validation Coordinator Food Scientist Project Engineer Life Science Sales Development Executive Engineering Regulatory Affairs Executive Equipment Engineer IT Analyst Healthcare QC Analyst Medical Device Medical Affairs QA Validation Specialist Chemist Facilities Engineer Senior Research and Development Engineer Process Development Engineer Life Science Contract Dublin Manufacturing Executive Dublin North