User:Seguncha

I work as a Director of Quality Control at Aeras (Tuberculosis Vaccine Research and Development Company) with overall responsibility for the Quality Control Testing Laboratory. I have over 22 years of extensive experience not limited to Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Quality Assurance, Vaccine Development, Product Design, Testing and Validation. I am vast in national and international regulatory bodies’ requirements and regulations such as the FDA, EMEA, EU, TGA, JP, ISO etc. Throughout my career, I have worked individually and within several teams to be successfully in the various regulatory bodies' audits, pre-approval and post approval inspections amongst others. I have extensive industry experiences within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic Processing and Quality Control subject matter expert for various fortune 100 Pharmaceutical, Biotech and Medical Device companies that I have worked for in the past. I have also represented these fortune 100 companies during critical inspections for approval of their new and modified products from proof of concept, development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, licensure, and government affairs activities. Most recently, I am directing the QC test lab for associated testing of clinical trial products for new generation tuberculosis vaccine and in the past has led the startup, re-structure and re-organization of various commercial biologics, pharmaceuticals, radio-pharmaceuticals, biotechnology and medical devices companies within the Quality Control organization. I am actively involved in the initiation, start up and continuity of the new CMO business that Aeras just initiated.My experience in large-scale biological product development, testing, sterility assurance, quality control, quality assurance, validation, manufacturing processes, production and process controls applicable to successful vaccine production and release is coupled with my other technical background and subject matter expertise in the area of Quality Control/Quality Assurance divisions.I am also a member of the Parenteral Drug Association, Association of Microbiologist and involved in several groups and forum discussions for experts in my field of study and management. Learning and aquiring additional skills and advanced knowledge through the course outline in the Advance Academic Program (Biotechnology) will aid me in gaining the additional technological advancement that will complement my commercial manufacturing skills as a Quality Control Director.