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’s, 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.

Industry

Employment Type

• Full-time