Project Manager Management
Resume:
DAVID W. BUTLER
*********@***.***; http://www.linkedin.com/in/DWButler
EXECUTIVE SUMMARY
I am a dynamic, dedicated and action-oriented leader in pharmaceutical engineering and operations, seeking senior level
management position with a growing organization. 15+ years international experience in strategic and tactical planning,
implementing capital growth projects with budgets up to $50+MM in facilities, processes and laboratories. 10+ years
background bringing Operational Excellence to reduce costs and improve quality, implementing Lean Six Sigma and
Lean Manufacturing methodologies. Well-versed in management of cGMP and QbD for operations and facilities on 4
continents. A veteran enabler of safety and environmental programs, having implemented and managed behavior based
safety programs (Dupont-based program) and projects for compliance with new regulations.
PROFESSIONAL EXPERIENCE
COLORCON Inc., Harleysville, Pa. 1998 - present
Dir Global Engineering & Facilities, US & UK Micron Tech, Inc (MTI, Owned By Colorcon) 2012-Present
• Direct and manage all global capital engineering projects for equipment and facilities.
• Strategic planning & engineering to meet the three year business sales objectives.
• Apply six sigma and lean concepts to improve productivity, quality and safety.
• Responsible for global EHS including safety program implementation and environment permitting & reporting.
Selected Accomplishments:
• Deployment of flexible containment for extra protection during API processing.
• Identified critical facility system redundancy needs with a capital plan to address.
• Chair all safety committee meeting and identified potential safety issues with a remediation plan.
• Strategic facility planning for the UK facility expansion.
Director of Operations, US Micron Technologies, Inc (MTI, Owned By Colorcon) 2010-2012
• Directing day-to-day manufacturing and facility operations for a >$20MM business, ensuring compliance with
the cGMP and regulatory policies and procedures.
• Leading strategic and technical management of staff, equipment and facility.
• Maintaining flexible resource scheduling and responsiveness to meet/exceed customer needs.
• Managing safety programs and processes for a manufacturing facility of 30 technicians, 3 supervisors and
maintenance staff.
• Driving continuous improvement and Process Excellence, by developing and maintaining operations metrics for
productivity, production output and safety.
• Developing and managing operations expense budget of >$15MM and capital budget of >$5MM.
Selected Accomplishments:
• Used Root Cause Analysis (Kepner Tregoe) to identify production deficiencies, and resolved problems
through hands-on operator training, improved procedures and Six-Sigma improvement projects. Saved $100k in
manufacturing costs.
• Benchmarked performance of MTI versus the industry, through an hourly rate market analysis comparing
current industry standards with that of MTI. Analysis showed market adjustments were needed in salaries and
various expenses; all recommendations were approved by executive management.
• Developed new system for of post micronization templates, for measuring operator output and schedule
adherence. System was used in a Pareto analysis of losses, to formulate strategic goals for manufacturing.
• Developed Master Scheduling system in Excel/MS Project, increasing schedule adherence by 10% in first
year.
Senior Global Project Engineering Manager 2007-2010
• Was recruited from prior staff-management role for a line-management role, directing and managing the two
largest capital projects in company history, with a combined budget of $67MM.
• Managed from design to completion a green-field $47MM LEED Gold Certified HQ, including R&D Center and
Laboratories, consolidating employees from 5 separate sites. Project was completed on-time, on budget, on
specification, and received awards/nominations for energy efficiency, architectural design, and data center design.
D. W. Butler (*********@***.***) Page 2 of 3
• Managed from design to completion $20MM API processing facility, doubling capacity in response to customer
demand. Designed the entire facility based on Lean Manufacturing and energy minimization principles, to
minimize fixed costs and operational complexity.
Director of Global Engineering 1998-2007
• I spearheaded global strategic planning plus management and execution of capital project portfolio, to
support company growth from $200MM to $400MM in sales.
• Provided the leadership and communications for safety and environmental processes and programs
worldwide.
Selected Project Accomplishments:
• Constructed manufacturing and distribution facilities for oral solid dose coatings, excipients and pigments in US,
Brazil, China, India and Japan, with combined project budgets of $50MM.
• Constructed new Technical Service Labs in Canada, Brazil, Argentina, Mexico, Germany and China budget $7MM.
These centers gave local focus on customers, helping double revenues within 5 years.
• Piloted and validated new blending technology for pharmaceutical excipients, improving quality from 90% to 95%
FTR (first time right) and reducing cycle times by 30%.
• Led construction of new, $5MM US manufacturing facility for Modified Release product line. Capacity was
necessary to meet forecasted demand, and product sales increased by 50% in the 2 following years.
• Led strategic facility planning for Global HQ, NA Operations, and R&D, with a capital budget of $25MM.
• Implemented Lean Manufacturing in batch processes, eliminating constraints and reducing cycle times by 25%.
• Instituted behavior-based safety program (based on Dupont STOP) to reduce at-risk behaviors by 50% worldwide.
Centocor Bio Pharmaceuticals Inc., Malvern, Pa. 1998-1998
Sr. Project Engineer
• Design and project management of facilities for R&D Labs and Pilot Plants.
• Developed and executed facility strategic plans and led all lease-space negotiations.
• Manufacturing project budgets, schedules, equipment specs, project implementation and validation.
• Engineered corporate and research facility space programming and with $5MM project capital budget.
MARSAM Pharmaceuticals Inc., Cherry Hill, N.J. 1997-1998
Project Engineer
• Engineering & Project Manager for production facilities, offices and labs, with a $5MM capital budget.
• Engineering & Project Manager facility expansion for sterile powder and liquids processing units, including
process equipment and QA/QC lab. Budget $1.6MM.
• Engineering & Project Manager for powder batching & blending facility oral solid dose. Total budget $650K.
• Prepare, executed and completed IQ/OQ/PQ validation protocols for facility and equipment projects.
NOVARTIS CONSUMER HEALTH, INC., Fort Washington, PA 1987-1997
Project and Facility Services Manager
• Engineering Project Manager for oral solid dose manufacturing capital projects for granulating, tablet and capsule
manufacturing. Project budgets $50K to $2.5M.
• Engineering Project Manager for oral suspension manufacturing and packaging capital projects. Project budgets
$10K to $700K.
• Managed Building Services Dept day-to-day operations; reduced waste costs by 25% with recycling.
• Increased productivity of 5 processes by reducing batch cycle times up to 50% and by implementing SMED (quick
changeover) methodology.
• Developed and executed 24 oral does and liquid suspension facility/equipment validation IQ/OQ/PQ protocols,
preparing final reports and SOP’s, to bring the company into compliance with changing regulations.
EDUCATION
Columbia Southern University (Continuing Education): Project Management, (GPA 4.0)
Penn State University: Business Management Courses (GPA 4.0)
Penn State University: Mechanical Engineering Certificate
American Institute of Design: Associate’s Degree
PROFESSIONAL DEVELOPMENT & ORGANIZATIONS
Villanova University: Black Belt & Green Belt in Lean Six Sigma for Manufacturing.
D. W. Butler (*********@***.***) Page 3 of 3
Franklin-Covey: Leadership Training Series
ISPE Delaware Valley Chapter
SOFTWARE
Oracle Business Applications, AutoCAD, Visio, MSOffice Suite: Word, Excel, Powerpoint, Access.
Contact this candidate