Product Development Associate Scientist Ii
CurrentKey Responsibilities and Duties include:1) Write protocols for the verification and validation of products under development, to address all the design inputs and business goals of the product. The protocols were written to conform to the quality system requirements (internal and external SOP and GLP guidelines), while working closely with Quality Assurance and Regulatory Affairs teams.2) Design and plan experiments based on the protocol requirements by setting up spreadsheets with pertinent information and calculations to increase the team's efficiency. 3) Order and keep an updated inventory of the necessary reagents and pathogenic strains required for the project, based on the calculated estimates.4) Handle biological samples in biosafety cabinets in a BSL-II laboratory, which include diluting and processing respiratory and gastrointestinal samples.5) Document all pertinent information (reagents & equipment) of each experiment on appropriate data form or lab book, while following the proper SOP.6) Prepare samples of test panels for multi-site (internal and external) reproducibility studies, manage and analyze the results data, and provide feedback/answers to questions from clinical sites, working closely with the Clinical Affairs/Operations team.7) Troubleshoot and identify the root cause of unexpected results.8) Analyze the data from verification/validation studies and present the data to the team as well as in the form of a study report.9) Write the Analytical Performance section of the product Package Insert, which describes the results of the verification/validation studies, in addition to participating in the reviewing of the draft of the Package Insert.10) Provide training and technical support to junior members of the team.Additional role:Biosafety Officer (BSO) of Luminex Toronto (Started February 25, 2022)