Description
SUMMARY OF EXPERIENCE: Results-driven Pharmaceutical Manufacturing and Technology Transfer professional with over 27 years' experience in global pharmaceutical (Ethical and Generic) and personal-care companies. Managed operating efficiencies and quality through strategic planning, partnering, teamwork, and effective problem solving techniques in plant operations that generated significant improvements. Effectively leveraged expertise in Food and Drug Administration's good manufacturing practices, risk mitigation and cross contamination management, enterprise resource planning, and operational excellence to meet corporate objectives. Demonstrated strengths include: proven organizational leadership, extensive knowledge of production operations and technology transfer, product and process re-engineering, ability to manage cultural changes within workplace and ability to implement strategic projects through multi-functional teams. A creative problem solver with strong interpersonal and communication skills and the ability to consistently meet corporate targets. CAREER ACCOMPLISHMENT * Hands-On experience in Manufacturing, Packaging, Technology Transfer, Product and Process Re-Engineering of Solid Dose, Semi-Solid and Liquid and operations. * Managed the start-up of Sterile manufacturing operations. * Implemented lots of cost improvement initiatives reduction in change over down time, batch campaign scheduling, product yield, right the first time documentation system, reduction in OSHA incidence and product back order issues by effectively utilizing available resources. * Implemented a 24/7 shift operation with zero cost to my company * Coordinated and Conducted Site audit /due diligence audits which include site preparation for FDA, MCA, MHRA, DEA and OSHA. * Participated in a complex technology transfer, supervising teams of employees, managed third party contract manufacturing, pilot plant operations and scale-up production size batches. * Managed comprehensive validation programs including cleaning and process for large-scale pharmaceutical and personal care products. * Coordinated team of research scientist that conducted BA/BE study of USA and EU developed products. * Led a team of scientists that developed Branded and Generic products for the launch in USA and EU market and also technology transfer to other Emerging Markets. * Managed Watson Labs Pharmaceutical site at Copiague New York for 3 years. * Led a team that launched Excedrin and Aspirin-Free Excedrin Gel Tabs at Bristol-Myers Products * Increase Capacity by over 25% at PII
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