ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Benchmark all CDMOs with scorecards for quantitively decision making. * Created plans to produce and distribute clinical materials in Biologics plants, GLP Cytotoxic Labs and Radioisotope labs to allow company to have more control, flexibility and capability for toxicology studies, phase I/II clinical materials in R&D project portfolio. Reduced ~$4 million operating costs and up to 12 months of time-to-market duration. * Transferred and validated clinical to commercial manufacturing plants equipped and started up plants that contained cell culture and fermentation USP and DSP areas, wet granulation processes, aseptic Fill/Finish facilities, complex USP/WFI water systems, Clean HVAC and Building Automation Systems. Reduced estimated validation time by ~ 25%. * Supported cross-functional, cross-continent teams while assuming accountability for multi-year projects that entailed the build and start-up processes for multi-facilities manufacturing sites. Completed assignments in successful product delivery, ISO 14001 certification, and savings of > $5M through increased efficiency of manufacturing systems and reduced capital needed to increase ROI. * Scaled up and transferred existing legacy manufacturing processes to a New Manufacturing Facility complying with applicable FDA, EU, JP cGMP, ICH regulations, used QbD approaches to increase long-term compliance and reduced risks for obtaining regulatory approvals. * Successfully synthesized complex solid, parenteral and biologic facilities including processing equipment, aseptic filling operations, critical utilities, clean HVAC systems, Loss Prevention, process controls and automation for the plant. Gained extensive technical and project management expertise in all phases/stage gates of drug products development and manufacturing for successful project implementation. * I developed, reviewed and approved corporate engineering design standards and policies for use in multi-sites. I created SME Risk assessment matrix for introducing new products to external sites. Career Track

Highlights:

• Engineering
• Manufacturing
• Compliance
• ECMS
• HVAC
• Infrastructure
• Material Handling
• OSHA
• Business Development
• Management
• director
• consultant
• regulatory compliance