Helping companies start or expand clinical / commercial production, solve problems, improve operations, reduce costs, and design / build / qualify / maintain facilities.

Expert in facility, equipment, and utility design, qualification, and operation for oral and sterile manufacturing facilities. Conducted regulatory readiness and GMP audits, remediated regulatory findings for several sterile facilities, wrote corporate level policies, and implemented best practices. Provided extensive international consulting services- hold visas for India and Brazil.

Development and leasing of commercial and residential real estate.

Selected as head of engineering for the combined Teva / Cephalon company. Created the Americas Engineering Group to manage design, construction, commissioning, and qualification of capital projects at office, laboratory, and 21 manufacturing facilities in the United States, Canada, and Latin America. Directed package engineering and provided oversight of maintenance activities.► Managed a capital budget of approximately $100,000,000 per year, with emphasis on new product launches, site consolidations, efficiency improvements, cost reduction, and GMP/EHS/DEA compliance.► Restructured engineering and facilities departments to achieve $1,000,000 per year savings.► Installed and qualified facilities and equipment for Teva's largest product launch in 2013.► Standardized capital, validation, and maintenance systems / procedures throughout the Americas.► Reduced operating costs by $2,700,000 per year using LEAN techniques.► Rapidly built OSD manufacturing facility in Mexico to replace impaired production capacity.► Sponsored automation, Lean, and Six Sigma projects, enabling 25% headcount reduction.► Directed global equipment remediation program to fulfill urgent commitment to FDA.

Created Cephalon’s corporate engineering group to manage global facilities as well as design, construction, and qualification of office, laboratory, and manufacturing facilities worldwide. Directed corporate security and global environmental, health, and safety.► Expanded production capacity at receiving site, transferred products, received regulatory approvals, and sold idle site, resulting in $10,000,000 per year savings. ► Wrote / implemented corporate capital policy to standardize business processes worldwide. ► Managed expense and capital budgets of $25,000,000 and $75,000,000/year, respectively. ► Exceeded department objectives while coming in more than $1,000,000 under budget each year. ► Identified and implemented cost-saving initiatives of $700,000 each year. ► Achieved OSHA incident rate below 1.0 in each year. ► Standardized maintenance procedures at North American sites using Maximo as CMMS.. ► Developed long-range plans for major manufacturing, laboratory, and office sites worldwide. ► Consolidated three sites in United Kingdom into one, saving $1,000,000 per year in rent.

Hired as Cephalon's first commercial manufacturing person. Created Cephalon’s worldwide commercial manufacturing organization using internal and contract facilities, both domestically and internationally. Established effective strategy for complex global supply chain and product inventory. Negotiated numerous domestic and international supply agreements. Led design, construction, and qualification of manufacturing plants. Directed clinical supply manufacturing, packaging, and distribution. ► Built commercial manufacturing organization to support $1.2 billion in annual product sales. ► Created company’s Competitive Sourcing Group to reduce manufacturing costs. ► Reduced PROVIGIL contract manufacturing cost by 70% over five years, saving $4,000,000 per year. ► Reduced ACTIQ manufacturing cost by 40% by transferring manufacturing in-house. ► Converted samples from bottles to blisters, saving $1,000,000 per year. ► Built new clinical supply manufacturing, packaging, and labeling facility. ► Negotiated numerous domestic and international contract manufacturing agreements. ► Directed $130,000,000 in domestic and international capital projects to increase capacity. ► Established excellent relationship with DEA to obtain quota for rapidly growing product.► Wrote manufacturing sections for domestic and international regulatory filings.Senior Director – Technical Operations, 1999-2000.Managed worldwide contract commercial manufacturing, contract clinical manufacturing, and clinical supply distribution. ► Launched PROVIGIL, company’s first drug product, ahead of schedule in U.S. ► Identified contract manufacturer and negotiated supply agreement, lowering costs 40%. ► Negotiated development and supply agreements for several drugs entering clinical studies. Director – Technical Operations, 1997-1999. ► Launched company's first commercial product, PROVIGIL, in United Kingdom and Ireland.

Hired as AutoImmune's first commercial manufacturing person. Managed technology transfer, scale-up, validation, and clinical / commercial supply operations at contract manufacturers. Produced drugs for phase III clinical trials. ► Engineered 3-fold increase in plant capacity through process and equipment optimization. ► Improved product quality and consistency through process optimization and control charting. ► Authored batch records, SOPs, and validation documents. ► Invented equipment resulting in $300,000 per year savings. ► Wrote sections for product license application to Center for Biologics Evaluation & Research.

Director – Manufacturing, 1992-1994.Directed start-up and qualification of a new $60,000,000 recombinant DNA drug production facility, which included fermentation, purification, aseptic processing, and clean room operations. ► Exceeded design productivity while meeting timeline and budget. ► Validated utility, laboratory, process, and computer systems to FDA standards. ► Established training, preventive maintenance, calibration, and change control programs. Director – Manufacturing Operations, 1990-1992.Led all manufacturing operations at the site, including quality, human resources, procurement, environmental, safety, and site services. ► Transformed company culture to a pay-for-performance system. ► Reduced operating costs by more than $1,000,000 each year.► Negotiated contract manufacturing agreements. ► Set company record for safety excellence.

Director – Process Development, 1987-1990.Managed 21 people responsible for scaling up new processes and improving existing processes. ► Managed scale-up and optimization of recovery process for recombinant DNA drug. ► Solved product quality problems and increased pilot production 400%. ► Developed design data for construction of $60,000,000 production plant. ► Implemented cGMP pilot operations and produced drug for clinical studies.Manager – Process Development, 1984-1987.Managed 14 people responsible for developing new and improved products and processes. ► Patented antibiotic recovery process and produced drug for clinical trials. ► Developed department safety program, reducing accident rate by 90%.Senior Research Engineer, 1983-1984Research Engineer, 1981-1983.FOR A DETAILED LIST OF ACCOMPLISHMENTS, please request my resume:610-457-8073boburban@comcast.net