Jacob Simon

Background

About Jacob Simon

I am a highly accomplished quality control professional with over 30 years of experience optimizing the performance of quality control/quality assurance operations within highly regulated biotechnology environments. Utilizing my subject matter expert knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), I have significantly improved processes to achieve exacting quality standards across all product manufacturing stages prior to release. Throughout my career, I have focused on building, training, and directing high-performance QC teams. In my most recent role as Senior Director, QC, my team was made up of a QC Manager and seven skilled QC Analysts who played a critical role in testing a variety of products to ensure they met FDA and European Union regulatory requirements. I created a strong work culture for my team, providing them with ongoing training and mentorship to ensure they operated at peak performance and delivered exceptional results. A major part of my work has been delivering improvements to quality control systems and processes. With IRX Therapeutics, Inc, I made huge strides for the company in multiple areas such as slashing release testing turnarounds by over 50% and installing a next-generation cloud-based temperature monitoring system that enabled real-time monitoring of temperature sensitive products. I am in search of a new career challenge where I can showcase my advanced quality control expertise and leadership as part of an exciting pharmaceutical biotechnology company. My areas of expertise include: Quality Control/Assurance Management Environmental Monitoring Microbiological Testing Test Method Development/Validation Equipment/Computer System Qualification Change Control Corrective & Preventative Actions (CAPA) Regulatory Compliance Product Testing & Release Risk Management & Mitigation Team Building & Leadership Project Management Bioassays & Microbiological Assays Anti-drug Antibody Assays Cell Culturing & Counting