Avinash Ganesh Email & Phone Number

South San Francisco, Ca, Us

Los Angeles, California, United States

San Diego, California, United States

• Led and managed a team of 5 in validation activities to migrate 30+ analytical instruments to an Industrial Control Network (ICN) in a GMP facility within 6 months, ensuring 100% compliance with GMP standards.• Drove continuous improvement by creating visual KPI dashboards in Power BI to analyze process metrics, identifying optimization opportunities that increased validation project completion rate by 80% in 4 months.• Coordinated cross-functional collaboration by hosting weekly meetings and leveraging Power BI dashboards to resolve 2-3 validation project roadblocks weekly with QA, Regulatory, QC, and Engineering teams.• Facilitated process mapping sessions across cross-functional teams for new validation strategies, streamlining validation protocol workflows by 25% and reducing drafting and execution cycle times by 2 weeks.• Collaborated cross-functionally to validate 3+ analytical methods for testing drug product specifications, ensuring accuracy and reproducibility to enable delivery of high-quality therapeutics to patients.• Proficient in managing the validation process across the full lifecycle of various laboratory instrumentation, including but not limited to: ProteinSimple Jess system, NC-202 Cell Counter, Sciex PA 800 Plus, NanoDrop One C spectrophotometer, ddPCR Droplet Reader, Spectramax Plate Reader, High-Performance Liquid Chromatography (HPLC), Osmometer, High-Intensity Aerosol Counter (HIAC) Particle Counter, Kaye Validator, Incubators, Ultra-low temperature freezers (-150°C, -80°C), Standard temperature freezers (-20°C), Refrigerators (2-8°C)

San Diego, California, United States

• Authored, executed and reviewed SOPs, validation protocols, and technical documentation for 20+ analytical instruments, ensuring regulatory compliance with cGMP and data integrity per 21 CFR Part 11 requirements.• Optimized cycle development efficiency by 40% through iterative process improvements, leveraging agile methodologies to meet validation project deadlines effectively.• Identified root causes and implemented corrective actions for 15+ deviations by conducting in-depth investigations, resulting in enhanced product quality and compliance with regulatory standards.• Coordinated with QA, IT, and Engineering to facilitate seamless transfer of 20+ instruments to permanent GMP facility, ensuring compliance with cGMP, GDP, and data integrity per 21 CFR Part 11 requirements.• Conducted 20+ comprehensive risk assessments, identifying potential risks and developing effective mitigation strategies for analytical equipment

Lafayette, Indiana, United States

• Reduced manufacturing time by 66% by utilizing Zuken's E-CAD Design Software, E3 series to design electrical connectors to streamline wire harness manufacturing processes.• Assembled 50+ electrical panels and wire harness formboards with precision tools, achieving a 30% reduction in manufacturing lead time while maintaining high quality standards in electrical component assembly.• Developed the Kirby Risk Additive Manufacturing Database using SQL in Microsoft Access, optimizing documentation and organization of 3D parts and prints, improving retrieval times by 50%.

Indianapolis, Indiana, United States

• Developed and simulated multiple layout configurations using FlexSim, resulting in a 78% increase in daily throughput from 323 to 576 parts, optimizing production efficiency.• Conducted cost analysis and financial modeling for proposed manufacturing solutions, achieving a 467% ROI and reducing annual operating costs by 25%, contributing to a projected annual profit increase of 15.03%.• Implemented a final ideal layout solution that met client demands, resulting in a daily throughput of 704 trim plates, surpassing daily demand of 700 trim plates, while reducing average system lead time and work-in-progress parts by 30%.• Implemented troubleshooting protocols for equipment issues, resulting in a 30% reduction in average downtime per month, enhancing production uptime and operational efficiency.

• Constructed a socio-demographic model for Tippecanoe County which simulated population, households, occupations, and routines• Designed a static network based model which accurately mirrored population and businesses to simulate day to day life• Analyzed results from running disease spread model over simulated population to determine optimal mitigation strategies for COVID-19• Utilized R/Rstudio to clean and analyze data files, as well as to build network-based models for simulation

Palo Alto, California

• Conducted testing on company's miniature microscope product, collecting and analyzing data sets using Python and Excel, leading to a 15% increase in product reliability.• Developed and maintained work instructions, Bill of Materials (BOMs), process specifications, and reports for microscope testing, achieving a 20% improvement in testing efficiency and documentation accuracy.• Utilized power tools to construct testing environments and employed precision measuring devices to inspect microscope parts, achieving a 25% reduction in testing setup time and ensuring parts met quality standards.• Designed and implemented a Python-based process automation program for file management, resulting in a 30% reduction in administrative workload for the Quality Control team, enhancing overall workflow efficiency.

Palo Alto, California

• Shadow and provide assistance to Mechanical Engineer• Perform mechanical testing of accessories (protection cone, cable, baseplate) for microscope• Perform mechanical assembly and testing of other components for new microscope development

Bachelor'S Degree, Industrial Engineering

High School Diploma