Canada
Manufacturing: • Lead the manufacturing team in manufacturing ARC's liquid adhesion barrier medical device successfully where products are used in two clinical trials. • Maintained high quality standard complies with ISO 13485. • Determined potential hazards and risks in ARC's manufacturing process and developed prevention and mitigation strategies and solutions to minimize risks (FMEAs). • Maintained manufacturing-related documents in Design History File, Device History Record, Device Master Record and Medical Device Files to meet regulatory requirements and contributed to regulatory submissions resulting in two successful clinical trial applications and numerous Health Canada Special Access Program applications. • Served as Material Review Board member to actively review and resolve non-conformances and CAPAs. Supply Chain Management: • Led negotiation and execution of agreement with contact manufacturing organization. • Identify, acquire and evaluate suppliers to provide materials and/or services that are essential to ARC's operations. • Manage purchase of materials and services for production, shipment, and distribution of ARC's products.
Formulation: • Key contributor to invention and R&D activities including structural characterization and modification, physiochemical properties determination, and extraction & purification studies of polysaccharides, resulting in new intellectual property and multiple internationally granted patent families. • Established in-process and final product specifications through innovative formulation and development work in designing and formulating ARC’s safe and efficacious surgical adhesion liquid barrier medical devices. Manufacturing: • Co-developed and supported scale-up of manufacturing process for ARC's medical device products. • Directly involved in hands-on manufacturing of medical device products under GMP conditions, supporting production from development through scale-up. • Designed and executed installation, operational, and performance qualifications (IQ/OQ/PQ) for manufacturing equipment and processes. • Maintained a GMP and ISO 13485-certified manufacturing facility for production of key medical device components.
ARC Medical Devices Inc. is dedicated to the reduction of harmful surgical adhesions through development of innovative polysaccharide-based liquid medical devices. As part of the diverse team, I am a key contributor to R&D activities including structural characterization and modification, physiochemical properties determination, and extraction and purification studies and optimization of ARC's liquid medical devices' key components which resulted in creation and expansion of ARC's patent families. I have co-designed, co-developed and scaled-up the manufacturing process for ARC's products complies to ISO 13485 along with in-house safety and quality specifications.
• Aid in developing and improving novel techniques to neutralize endotoxin’s toxicity • Discovered major breakthrough in reaction mechanism between endotoxin and Polymyxin-B • Characterized endotoxin bioactivity in whole blood via ELISA and chromatography • Developed alternative economic method in treating endotoxemia and sepsis
• Synthesized and investigated novel solid solution systems for practical lead-free piezo- and ferroelectric materials • Characterized ferroic materials with X-ray crystallography and magnetic susceptibility tests • Determined phase transitions and critical behavior of materials via dielectric spectroscopy • Employed SEM to study the micro-structure of materials and structure-property relations