Austin Ruth
Manufacturing Scientist @Kashiv BioSciences LLC
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WORK HISTORY
Manufacturing Scientist @Kashiv BioSciences LLC
Piscataway, NJ, US
Executed end-to-end upstream and downstream biologics manufacturing processes, including media preparation, cell culture, and purification contributing to production of two different biopharmaceutical products from mammalian cell lines.• Manufactured biological products using both fed batch and perfusion (ATF) processing.• Supported successful passing of first-time MHRA audit of site.• Owned the assessment and GMP integration of 300+ materials, 50+ equipment, and 10+ analytical systems, reducing processing timelines by ~82% and ensuring regulatory compliance. • Critical to the implementation of a new LIMS system in the manufacturing process, increasing sample submission efficiency by ~70% and reducing errors by ~40%.• Facilitated scale-up of batch production from 500L to driving increased throughput and operational efficiency.• Created and maintained asset IDs and work orders in BMRAM system, streamlining inventory tracking and compliance.• Operated AKTA purification systems, UV-Vis spectrophotometers, Meta-Flex analyzers, and bioreactors to ensure product quality and consistency.• Leveraged Cytiva UNICORN software for real-time chromatography monitoring and data analysis during harvest purification steps.• Authored and implemented Master Batch Records (MBRs) based on technology transfer documentation to support scale-up and commercial readiness.• Supported equipment commissioning and qualification (IQ/OQ/PQ) for new systems in a commercial GMP manufacturing suite.• Partnered cross-functionally with Quality Assurance (QA), Quality Control (QC), Microbiology, Process Development (PD), Analytical R&D, and Material Management to ensure batch success and regulatory compliance.• Collaborated with senior leadership (AVP, Director, Managers) to meet aggressive production timelines and milestones.• Drafted, revised, and implemented standard operating procedures (SOPs) to align with evolving GMP and regulatory standards.
EDUCATION
Stevens Institute of Technology
Master of Science - MS, Chemical Biology
Stevens Institute of Technology
Bachelor of Science - BS, Chemical Biology
Parsippany Hills High School
High School Diploma
ABOUT AUSTIN RUTH
Graduate student at Stevens Insitute of Technology and majoring in Chemical Biology and gaining a certificate in Drug Discovery. I am excited to use my experience with leadership and passion for biology and chemistry to help others and make a difference. Currently, I am looking into the pharmaceutical industry for professional opportunities. I am interested in the research and design field for medicinal chemistry, the business aspect of the pharmaceutical industry, biochemical research, and cancer research. I look forward to furthering my education and skills in these areas!
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