Shiva Kurre

WORK HISTORY

EDUCATION

ABOUT SHIVA KURRE

I am an accomplished professional with 25+ years of experience and a proven track record of success in a wide range of pharmaceutical manufacturing operations of which 8 years in leadership roles. I am highly motivated and committed to creating value in manufacturing and technical operations and believe in continuous improvement and new ideas to spur growth in the business. I am skilled in handling a wide range of cGMP operations in the area of oral solid, liquid, topical, and aseptic dosage forms. I have hands-on experience in commercial manufacturing and packaging operations, plant maintenance and engineering services, EH & S, operational excellence, application of lean manufacturing and statistical tools, technical services, new product launches, product portfolio management, site mergers, and consolidations. I am an excellent cross-functional collaborator, detail-oriented critical thinker, problem solver, team builder, and effective communicator. I thrive working in a collaborative matrix environment. Core Competencies:Provide leadership in pharmaceutical operations: • Commercial operations: Manufacturing, Packaging, Engineering services, Operations Strategy, Operational Excellence, supply chain, and EH & S. Operations Budgeting, resource planning, and supporting plant-level P&L.• Technical Operations: Project management, new technology introductions, Process Development, CMC for ANDA/NDA filings, Process Validations, Equipment Validations, and Cleaning Validations in multiple manufacturing sites.• Greenfield projects, facility, equipment commissioning, and startup. Deployment of Quality systems, Regulatory and Compliance Management. Change management, Process engineering, process optimization, application of Lean manufacturing principles, statistical process control, Product portfolio management, strategy deployment, value stream mapping, Kaizen, and Kanban.• Proven leadership qualities in hiring, coaching, mentoring, and developing people\'s talent, capabilities, and team building. Six Sigma Green Belt Certified. Promote a culture of teamwork, collaboration, empowerment, and accountability across the plant operations. Ensure quality and right-first-time philosophy as the highest priority in operations, and champion a LEAN manufacturing and Quality Culture.