Reut Levi Mutai

Since joining ADOR Diagnostic in 2021, my role has been multifaceted. I collaborate with international engineering teams to convert complex biological processes into automated products. Our focus is on precise pathogen detection, and we use advanced molecular biology techniques like qPCR, PCR, and RCA to drive innovation. In product development, I've been integral in the NPI Process, working to incorporate biological functionality into new prototypes. I apply DFM principles rigorously, conducting comprehensive feasibility and fluidics tests to ensure that the designs are innovative but also practical and manufacturable. Teamwork is key. I work closely with cross-functional teams and the quality assurance department to streamline product design and production processes. We create and refine SOPs, focusing on efficiency and compliance. In this vein, I manage the biological manufacturing team, overseeing adherence to protocols and the successful execution of our automation processes. Risk and gap analysis also fall under my responsibilities. I evaluate product designs based on their biological flow to ensure they are robust and reliable. This analysis allows us to preempt issues and create products that meet and exceed expectations.

From 2018 to 2021, I served as a Process Development Associate at Minovia Therapeutics. My role involved spearheading new QC tests and leading an automation project on the CliniMACS Prodigy platform. This allowed for a smooth transition of processes from the development phase to manufacturing. As leader of the manufacturing team, I conducted clean room validations, specifically OQ and PQ, and bequeathed clean room practices using GMP practices implementation. This led to measurable improvements in both product quality and compliance. One of my key responsibilities was to assist in establishing our quality systems. This involved incorporating Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and multiple ISO standards, including ISO 14644, ISO 9001, and ISO 13485. I also helped set up quality assurance processes in line with these standards. Training staff was a crucial part of my role. I trained team members in various areas such as stem cells, tissue handling, ELISA, flow cytometry, and digital PCR. Additionally, I wrote SOPs, BPRs, CCs, and risk documents to standardize our operations.

Obtained promotion upon interning for 8 months, execution of an independent research project.

During my tenure as a Laboratory Control Room Operator from 2013 to 2017, my primary focus was monitoring and overseeing laboratory activities to ensure a smooth workflow. I was responsible for the real-time tracking of all ongoing parameters and equipment statuses, providing crucial data influencing decision-making. Utilizing software tools for data analysis, I helped maintain the integrity of our laboratorys.