Laboratory Scientist
Current- Managed the instrument validation process in order to start up a new fully-functioning clinical trials laboratory. From the creation of the validation plans to the execution of the procedure, the processing/interpretation of data, and the creation of the reports. The lab is now live and processing hundreds of samples a day, while still growing and adding more instruments at a rapid pace.- Validated an array of instruments in the medical diagnostics field ranging from the Siemen's Atellica, ADVIA 1800 and Centaur, to the Sysmex XN3100, AuWi Pro, and CS2500. As well as the DiaSorin Liaison XL to use for COVID testing.- Project management experience under strict timelines and FDA/NYS/CLSI guidelines under the direct supervision of the medical laboratory director.- Strong focus on data management and statistical analysis in order to provide rigorously detailed reports and audit ready files.- Preparation of analytical reports and strong technical writing of SOPs and validation plans.- Crucial attention to detail in formulating and executing validation plans and procedures.