Strategic Chemical and Specialty Chemicals Consultant: New Drug Applications and Development

Expertise

• Guiding clients through complex chemical technology development programs.
• Identifying new technology enabling business opportunities, process improvements, debottlenecking opportunities, and planning capital upgrades to increase productivity of specialty chemical plants.
• Defining the content of the(CMC) Chemistry Manufacturing Controls component of new drug applications (NDA) and developing the strategy for completion of necessary work in individual technology areas.
• Leading the effort to develop a guiding vision and organizational structure for startup specialty chemical companies.
• Assessing technologies for insulin production and evaluation for acquisitions.
• Establishing the optimum structure for the chemical technology and manufacturing functions of pharmaceutical companies.
• Leading new process development, process improvement, troubleshooting and plant productivity improvement efforts.
• Organic, inorganic and biotechnology products and processes.
• Establishing technology strategy to achieve company objectives.
• Assessing organizational requirements and designing optimum structures to meet client's strategic intent and sourcing key technical talent.
• Providing "Virtual CTO" capabilities to clients for crucial and challenging programs and leading organizational development initiatives.

Experience

Undisclosed Company, President, 2006 - Present

• Identified process improvement and debottlenecking opportunities, and planned capital upgrades to double the productivity of a specialty chemical plant.
• Led the effort that defined the content of the,(CMC)Chemical Manufacturing Control component of an new drug application (NDA) and developed the strategy for completion of necessary work in individual technology areas.
• Selected the optimum project management firm to lead a multi-hundred-million dollar expansion
• Led the effort to develop a guiding vision and organizational structure for a startup specialty chemical company.
• Assessed technologies for insulin production and evaluated a plant for acquisition.
• Established the optimum structure for the chemical technology and manufacturing functions of a pharmaceutical company.
• Provided intensive strategic coaching for 20 employees ranging from new supervisors to vice presidents in functions that included research and development, manufacturing, (HS&E) Health,Safety and Environmental commercial development, supply chain management, and clinical development.
• Facilitated the development of a strategic plan for a medical gases company.

Molycorp Minerals, LLC, Denver, CO, Vice President - Research and Development, 2012 - 2013

• Led the effort that optimized the composition and performance of a product for removal of arsenic from drinking water, and developed a commercialization plan.
• Institutionalized a rigorous data-based approach to product development along with statistical design and analysis to validate results.

FMC Corporation, Philadelphia, PA, Director Chemical Technology, 1991 - 2005

• Guided strategy development, opportunity assessment, planning and venture implementation for technology-enabled businesses-resulting in new markets and increased revenues for established products (e.g., persulfates and peracetic acid in environmental remediation and poultry processing, respectively).
• Led the effort to identify new technology platforms for the BioPolymer Division resulting in a new business unit with its own marketing and technical resources; NovaMatrix.
• Assembled the research and development effort, identified basic technology (in-licensed) and made breakthrough improvements to arrive at a technology to extract lithium chloride from South American brine sources.
• A major facility was constructed and is in operation in Argentina enjoying an industry low-cost position for lithium chloride.
• Developed a methodology ("Technology Review and Planning" format), to identify new business opportunities and operational improvements that integrates external market and technology input and aligns commercial, manufacturing and technology functions toward the most attractive business goals while improving employee effectiveness and morale in the process.
• Organized and led more than 30 reviews conducted on subjects that included plant troubleshooting, disaster recovery, cost reduction, new applications, pre-construction technology verification, new technology platforms, new business opportunities, potential business strategies, quality systems, customer service, and organization design.
• Led the effort to restore operations in two production plants that experienced major fires and identified the best future technology directions-organized and provided the resources to initiate and manage toll manufacture of products displaced from one of the plants that experienced a disabling fire.
• Conducted corporate-wide study of the process technology function that led to a reinvigorated and more effective and efficient process technology capability.
• Provided an entree into FMC for experienced new hires that rapidly moved into responsible divisional technical and commercial leadership positions.

Monsanto Company, St. Louis, MO, Research Chemist, 1967- 1987

• Supported the Technology Director and led the research effort to develop Bovine Somatotropin (BST)-an endogenous protein that improves the efficiency of milk production in dairy cows and is produced commercially by a biotechnology process.
• Initiated and managed the Monsanto BST research program from inception to regulatory submission and manufacturing startup.
• Managed the technical relationship with Genentech, the supplier of Monsanto's recombinant BST organism.
• Led biochemical, biological and pharmaceutical research on a worldwide basis including formulation of long range research and development plans, hiring people and building facilities-a research dairy farm, pilot plants and production facilities.
• Developed first-of-its-kind sterile, injectable, prolonged-release product for BST and developed a process for production of multi-ton quantities of bulk and finished products.
• Built and led a highly effective and motivated research and development department of more than one hundred scientists and support personnel.
• Provided the technology to allow Monsanto to advance from a clean-slate start to a leadership position in BST, shutting out established pharmaceutical companies. Monsanto Sales were reported to be approximately $250 million.
• BST business was sold to Eli Lilly in 2008 for $300 million and other considerations.
• Managed chemical research, developed a process and produced material for human clinical trials of an anti-cancer drug.
• Developed numerous processes for detergent materials, and managed pilot plant production of ton quantities for market evaluation.
• Initiated and led innovative programs in Monsanto's Corporate Technology HR Function to improve assessment, acquisition, placement and development of technical personnel on a corporation-wide basis.

Honors & Publications

Credentials

• FMC Chairman's Award for Lithium Chloride Production Process

Academic and Professional Affiliations

• American Chemical Society

Education

• Ph.D. Inorganic Chemistry, University of Florida, Gainesville, FL
• B.S. Chemistry, Florence State College, Florence, AL