Lauren Petrafassi
About Lauren Petrafassi
Lauren Petrafassi serves as the Senior Manager of Quality Assurance Operations at Marker Therapeutics, Inc. in Houston, Texas, where she has worked since 2019, bringing extensive experience in quality assurance within the pharmaceutical industry.
Work at Marker Therapeutics
Lauren Petrafassi serves as the Senior Manager of Quality Assurance Operations at Marker Therapeutics, Inc. since 2019. In this role, she oversees quality assurance processes and ensures compliance with industry standards. Her position is based in Houston, Texas, where she has contributed to the company's commitment to quality in cell and gene therapy. Her responsibilities include managing non-conformance issues, implementing corrective and preventive actions (CAPA), and conducting root cause analysis (RCA).
Education and Expertise
Lauren Petrafassi earned a Bachelor of Science (B.S.) in Biology/Biological Sciences from Regis College, completing her studies from 2001 to 2005. She possesses expertise in managing quality assurance processes, particularly in the pharmaceutical industry. Her knowledge includes phase-appropriate implementation of quality systems, qualification and validation of equipment, and ensuring compliance with regulatory standards in both the US and EU.
Background in Quality Assurance
Lauren has a diverse background in quality assurance and operations within the pharmaceutical sector. Prior to her current role, she worked at Bellicum Pharmaceuticals, Inc. as a Quality Assurance Manager and Quality Assurance Operations Specialist IV. Her earlier experience includes positions at Leiter's, where she served as a Senior Process and Validation Engineer and Process & Validation Manager. Additionally, she has held roles at Pharmaceutic Labs and Flex, contributing to her comprehensive understanding of quality assurance practices.
Professional Experience in the Pharmaceutical Industry
Lauren Petrafassi has accumulated extensive experience in the pharmaceutical industry, working in various capacities that enhance her expertise in quality assurance. She has held positions at Bioss USA Antibodies as Logistics/Operations Manager and at Flex as Device Specialist. Her roles have involved managing quality systems and ensuring compliance with current Good Manufacturing Practices (cGMP), particularly in the cell and gene therapy sectors.
Achievements in Quality Systems Management
Throughout her career, Lauren has demonstrated proficiency in managing quality systems and ensuring compliance with regulatory standards. Her work involves the qualification and validation of equipment, facilities, and products, focusing on adherence to US, EU, and GB standards. She has specialized in the implementation of quality assurance processes that support both small and large volume parenterals, contributing to the advancement of quality in the pharmaceutical industry.