Veteran Pharmaceutical Industry Leader responsible for managing all training activities at the Monroe Site. Also responsible for Training, Certification, and Auditing all personnel working in the core aseptic manufacturing area concerning proper gowning and aseptic techniques. Oversight for all QA responsibilities related to material release, batch review, and final batch release. Member of senior site leadership team and SME for all issues related to Aseptic Practices and Training.

Manufacturing and Pharmaceutical industry professional with over 29 years of experience in shop floor management, process improvement, product development, business development and marketing, and supply chain optimization. 14 years in agricultural, performance, and pharmaceutical intermediate chemical manufacturing. 15 plus years in contract/private label BFS (Blow Fill Seal) pharmaceutical development and manufacturing. Multiple years in each of many cross-functional leadership roles. ✔An unprecedented breadth of hands-on experience in every aspect of product development, manufacturing, packaging, business development and marketing, and supply chain management.

Led cross-functional, interdepartmental team in product acquisition and transfer project for eight major product lines. Implemented supplier redundancy program and improved Supply Chain by qualifying secondary/tertiary sources for all critical components and materials. ✔ Used leverage of additional suppliers to annualize cost reductions and increased return on recycled process scrap. Reduced spare parts inventory and achieved average annual savings of 3 – 5% per product line/year.

Streamlined the manufacturing process, increased productivity, and reduced costs while continuing to expand rapidly. Led engineering and operations team responsible for equipment and process improvements. Developed company-wide continuous improvement program. Set up project management program to coordinate all capital, new product, process improvement, and regulatory projects. Developed and mentored employee-driven continuous improvement teams.✔ Completed documentation reduction program that reduced process documentation by 30% and sample reduction project by ~15% per process. Implemented laser marking application to replace outdated typeset marking system. The project reduced process scrap by an average of 18% across six manufacturing lines. Built an in-house Warehouse Management System.

Led a newly established Business Development department in developing marketing materials, preparing business reports, and presenting the company to prospective equity partners. Worked with core senior team in a management buyout and led re-branding project for the company after equity buyout.✔ Negotiated supply agreements with pharmaceutical companies to grow manufacturing business and contract manufacturing agreement with former competitor. Developed blueprint and initial launch plan for a subsidiary generic pharmaceutical company.

Promoted to further refine the organizational structure of the organization, positioning it under one umbrella. Established new department organizational structure. ✔ Reduced costs by 20% through the elimination of redundant roles, implementing new schedules, and outsourcing noncritical tasks.

Brought in to restructure the management team to drive down decisions to shop floor and streamline the setup and turnaround. Established aptitude and skills assessment program for all new employees. Developed minimum standards and recruiting expectations. ✔ Increased capacity by 25% through the implementation of standardized container design. Reduced changeover time by 50% by streamlining the master batch record and eliminating redundant and unnecessary steps.

Oversight of day to day operations for agricultural, pharmaceutical and performance chemical manufacturing.