Jesse B. Email & Phone Number

Australia

Brisbane, Queensland, Australia

Brisbane, Queensland, Australia

• Operated in aseptic grade A cleanrooms, manufacturing medical devices and pharmaceutical combination products, for use in clinical trials and aseptic verification, resulting in the manufacture of a vaccine product for a pediatric phase 1 clinical trial• Operated in a team delivering pre-clinical animal trials for Influenza vaccine products, resulting in the team determining the effective vaccine dose for skin delivery for a novel vaccine patch• Selected to deliver aseptic aliquots of Influenza bulk vaccine material in a Grade A environment, producing x10 1L aseptic bags of vaccine for downstream processing• Processed x3 Influenza vaccine batches via TFF in preparation for utilisation in a novel vaccine technology• Executed the formulation of ‘coating solution’ with purified antigen, adjuvants and excipients for application to a novel vaccine medical device• Developed and updated documentation for ‘Aseptic Filling and Finishing’ procedures, in preparation for TGA audit of a new medical facility, enabling certification and approval for product commercialisation• Delivered change control processes, updating and refining obsolete procedures by correcting particle/CFU acceptance criteria in manufacturing SOPs• Preserved company reputation and capital, by avoiding approval of out of specification product that could have gone to clinical trial or end user• Contributed to Quality Assurance of manufacturing facility and medical products through completion of Deviations CAPAs and change controls• Collaborated with cross-functional teams to implement the IQ/OQ/PQ and validation of laboratory equipment, including autoclaves and particle counters in a new manufacturing facility in preparation for product manufacture and upscale• Validated Windchill Quality Management System (QMS) against specific organisational requirements, through the execution of functional testing (FT) and user acceptance testing (UAT)

Brisbane, Queensland, Australia

Sydney, New South Wales, Australia

Graduate Certificate In Environmental Science, Environmental Science

Certificate Iv In Laboratory Techniques, Clinical/Medical Laboratory Technician

Certificate Iii In Laboratory Skills, Biology/Biological Sciences, General

Bachelor'S Degree, Audio Production