Pharmaceutical - Medical Device Manufacturing, Operations and Quality Consultant

Expertise

• Pharmaceutical and medical device strategic planning, organizational development, supply chain management, and business focus.
• Implementing creative and innovative processes and solutions from a strategic, overall perspective, leveraging highly motivated teams to deliver optimal performance and results.
• Pharmaceutical, chemical and device manufacturing.
• Managing multiple global plant operations.
• Regulatory specific to: FDA, DEA, NRC, DOD, OSHA, (with International credentials).
• Developing high performing cultures.
• Acquisitions, divestitures and re-structuring.
• Product design, manufacturing and sterilization.
• Financial Management/P&L responsibilities.
• Quality systems and regulatory compliance.
• Supply chain management.
• Operational Excellence, Six-Sigma, Lean and 5S.
• Pharmaceutical and medical device operations ensuring high product quality, regulatory compliance, customer service, safety, (operational efficiency) and effectiveness.

Experience

Undisclosed Company, Service to Controlling Board of Directors, 2016 - Present

• Contract services organization committed to reliable and timely delivery of top quality products and services to the global life sciences industry.
• Director - Board of Directors and Executive Management Team.

RGMC, Consulting, LLC, President, 2015 - Present

• Consulting Services for pharmaceutical and medical device industries, specializing in operations, quality, regulatory compliance, supply chain, engineering, technical services research and development.
• List of clients: Cerberus Capital Management, Albany Molecular Research Inc., ICU Medical Inc., Regulatory Compliance Associates, AlphaSights, Gerson Lehrman Group, Guidepoint Global Partners, Coleman Research, Cognolink, and Third Bridge.

B. Braun Medical, Irvine, CA, Vice-President and General Manager, 2012 - 2015

• Pharmaceutical products operations for a $4 billion euro, 40,000 employee global medical products company.
• Led site operations for 1,450 employees, 4 building campus with a $300 million operating budget.
• Supporting production of sterile injectable pharmaceuticals, including general IV solutions, amino acids, and cephalosporins in a variety of drug delivery systems.
• Included molding operations (resin formulation, extrusion, injection, blow, FFS, assembly), and departments: Manufacturing, Quality, Technical Services/Engineering, Supply Chain, Finance, Human Resources, and Operational Excellence. Reported to Senior Vice President / Chief Operations Officer.
• Developed strategic plan for organizational optimization and reduction of 2 Director positions resulting in improved efficiencies and throughput, regulatory compliance, quality, and safety.
• Led organization through 3 successful FDA and multiple international regulatory agency inspections (including EU, Canada, Brazil), re-acquiring favorable (VAI) regulatory status.
• Initiated positive cultural change through training of all 1,450 site employees in OZ Accountability Culture principles and executing transformational tools.
• Completed commercial production start-up of the first new IV container technology in over 25 years.
• Achieved record annual throughput across 5 most business critical of 7 product categories totaling over 200 million units.

Teva Parenteral Medicines, Inc., Vice-President of Operations and General Manager, 2010 - 2012

• Directed site operations for 860 employee, 11 building campus and supporting injectable oncology products business for this $500 million, 860 employee subsidiary of Teva Pharmaceuticals USA, (an $18 billion global pharmaceutical company).
• Reported to Executive Vice President of Global Quality reporting to CEO.
• Developed strategic plans for regulatory compliance remediation, resumption of manufacturing operations, and return to market of key oncolytic products on FDA's drug shortage list.
• Participated in, and made presentations at, key meetings with the FDA and coordinated efforts with multiple consultants leading to the lifting of an FDA Warning Letter issued.
• Planned and executed 2 significant workforce reductions, reducing site headcount from 860 to 350 employees.

Covidien, Hazelwood, MO, Vice-President, 2006 - 2009
VP of Manufacturing Operations, Imaging Solutions

• Led 9 global manufacturing facilities, ($670 million operating budget) producing medical devices, active pharmaceutical ingredients and finished products for Contrast Media and Nuclear Medicines (reactor and cyclotron based). This including parenteral (injectable) products, generating sales of $1.1 billion, for or this $10 billion global healthcare products company employing 41,000 people worldwide.
• Managed Division Engineering ($80 million capital budget), and other departments: Operational Excellence, Contract Manufacturing ($45 million direct P&L), Supplier Reliability, and London radio-pharmacy operations. Reported to the Division President.
• Reduced operating costs $40 million and distribution costs $10 million by improving quality, safety, regulatory compliance and supply chain reliability through Lean, Six-Sigma, and 5S operational excellence and quality improvement programs.
• Restructured operations to merge two $1 billion divisions (Imaging and Pharmaceuticals).
• Implemented substantial quality, safety and regulatory compliance improvements at key sites to achieve successful FDA, NRC and OSHA inspection results.

Akorn Inc., Decatur, IL, Vice-President and General Manager, 2005 - 2006

• Specialty pharmaceuticals company engaged in the development, manufacturing, and marketing of branded and multi-source pharmaceutical products.
• Led all Decatur operations, including expansion and start-up projects within 2 existing manufacturing facilities.
• Oversaw departments that Included: Manufacturing, Quality, Technical Services and Engineering, Corporate Research and Development, Production Planning, Purchasing and Distribution. Reported to President and CEO.
• Transformed operation from Warning Letter to favorable FDA regulatory status in 7 months through focused implementation of facility, quality systems and personnel improvements.
• Reduced process cycle times 40% (from 5 weeks to 3 weeks) fill-to-release through process mapping and lean implementation.

Hospira Inc., Rocky Mount, NC, 1993 - 2005
Vice-President - Operations, 2004 - 2005

• Led plant operations at 3 different sites consisting of over; 2,600 employees, (which employed 14,000 worldwide) a $350 million budget, and 12 direct reports of this $2.5 billion global medical products company
• Responsibilities included production of sterile injectable products, molding and assembly of medical devices (such as IV infusion sets), and sterile processing of 70% of all Hospira medical device products through a 1.3 million curie Gamma Radiation facility. Reported to Vice President of Global Operations.
• As member of "top 50" corporate executive team, exceeded expectations for communicating and implementing the new corporate identity and strategic vision to Rocky Mount and Buffalo plants.
• Along with Head of Acquisitions for the purchase of a new emulsions plant, achieved media recognition by partnering and negotiating with NC Secretary of Commerce to secure a $1.2 million Job Development Incentive Grant.

Divisional Vice-President - Rocky Mount Operations, 2003 - 2004
Director of Operations, Rocky Mount, NC, 1999 - 2003

• Directed all operations at the highest throughput injectable drug manufacturing plant of its kind worldwide, with 2,400 employees, $1 billion in sales, and a $320 million operating budget for a 1.4 million sq. ft. facility.
• Delivered record throughput of 640 million units, by designing and constructing a $20 million facility expansion and renovating existing manufacturing, laboratory and office areas.
• Results were presented to Abbott Board of Directors as a benchmark for other facilities.
• Achieved record cost reductions of $17 million through result-driven leadership and a driving focus on key performance indicators.

Plant Manager, McPherson, KS, 1994 -1999
Plant Renovation Manager, 1993 - 1994

• Managed plant operations with 530 employees and a $79 million operating budget for a 294,000 sq. ft. facility.
• Promoted to Plant Manager after only 11 months as Plant Renovation Manager.
• Led facility through two acquisitions (Sanofi and Abbott) while continuing to deliver quality and financial performance, including $45 million in contract manufacturing revenues (direct P&L accountability).
• Developed and managed a 13-person Research and Development organization for the rapid development, approval and launch of generic injectable products.
• Under Sanofi Pharmaceuticals ownership, played a key role in Sanofi's divestiture, including delivering sales/business presentations to prospective buyers (including Abbott).
• Received "Excellence" (High Performance Work Teams).

Survival Technology (Meridian Medical), St. Louis, MO, Senior Director of Operations 1990 - 1993

• Recommended by President of Syntex to join Survival and direct all site operations for production of Syntex product line, representing 480 employees and a $30 million operating budget.
• Implemented major capital improvements and site expansion during a substantial surge in key government DOD military contract demands for nerve gas antidote (in auto-injector delivery system devices) at the outset of the Gulf War, while also meeting requirements for Syntex's product launch.
• Tripled overall production output within an 18-month period.
• Negotiated 3-year labor union contract, resulting in no significant cost increases.
• Featured as 'CEO' on front page of local business magazine.

Syntex Laboratories, Inc. Palo Alto, CA, Manager

• Oversaw packaging engineering and contract manufacturing.

Alcon Laboratories, Fort Worth, TX, Manager

• Oversaw packaging research and development.
• Received U.S. Patent

Honors & Publications

Academic and Professional Affiliations

• Parenteral Drug Association (PDA)
• International Society of Pharmaceutical Engineering (ISPE)
• Pharmaceutical and Medical Packaging
• Biotech & Pharma. Professionals Network
• Board of Advisors - Rocky Mount Area Chamber of Commerce
• Board of Directors - Nash Community College Foundation
• Board of Visitors - North Carolina Wesleyan College
• Board of Directors - Communities in Schools of the Rocky Mount Region, Inc.
• Member - Rocky Mount Industrial Organization
• Pharmaceutical Manufacturers Association (PHARMA)
• Chairman - Rocky Mount Area American Heart Association (Heart Walk)
• Sponsor - Drug Abuse Resistance Education (D.A.R.E.)
• Institute of Packaging Professionals
• The Society of Packaging and Handling Engineers

Awards

• CEO with Spirit" Award for leadership contributions
• "Excellence" Award for vision and training of High Performance Work Teams
• Featured as 'CEO" on front page of local business magazine.
• Academic Excellence Award from Michigan State University

Patents and Presentations

• U.S. patent (subject matter: Method For Dispensing Substances)
• With local Governor: Presentation and facilitated the Master of Ceremonies of on site facilities tour.
• Master of ceremonies in conjunction with the visit and presentation by North Carolina Secretary of Commerce and providing a personal tour of the facility.

Education

• B.S. Package Engineering, Michigan State University, E. Lansing, MI
• B.S. Microbiology/Public Health, Michigan State University, E. Lansing, MI