Quality Control Engineer

Company Description Toralgen is a preclinical stage biopharmaceutical company based in West Lafayette, IN, focused on developing and commercializing human therapeutics. Our poly-bile nanoparticle platform offers innovative solutions for overcoming challenges in biological oral delivery Role Description We are seeking a highly motivated and experienced QC Engineer to play a key role in the development of Toralgen’s platform delivery technology. The successful candidate will be assisting in the day-to-day nano formulation/process scale up, batch production, finished product dosing, packaging and shipping activities. They will also conduct data analysis on testing results Key Responsibilities Perform data analysis and statistical testing of batch test results as part of design of experiment tests on different formulations Assist/perform instrument preparation (i.e. cleaning, setup, assembly etc.) for the nano formulation batch production process Perform DLS particle size characterization on the nano formulations following detailed experiment/assay methods and report the results Execute drug loading and release methods as per the operational SOPs/study protocols Carry out finished product dosing (liquid or solid oral dose) and filling as required Assist/Perform bulk compounding and finished product dose preparation, packaging and shipping as required Assist/perform as a second check in the accuracy of the formulation/oral dose filling documentation entry process Follow good documentation practices by recording all the steps followed in the formulation batch production and dosing records in real time with minimal errors Always maintain accurate, neat, error free batch records, lab notebook entries and logbooks Prepare clean glassware, reagents, buffers and solutions as requested to run the formulation process/batches Basic Qualifications Ability to analyze data and prior use of statistical software At least 1 year experience in an Industry laboratory setting Some analytical instrumentation experience Experience in writing data summaries and preparing scientific presentations Ability to work within established procedures under moderate supervision Strong mathematical calculation skills and proficiency in using Microsoft Office applications is a must Handling computer assisted manufacturing and analytical equipment’s/software experience is preferred Ability to work within a team and as a strong team player with strong collaboration mind set, communication and interpersonal skills is a must Employment Type Full-time #J-18808-Ljbffr