Experience

Formulated Solutions

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Technical Services Manager

  • Jul 2001 - Present

  Cleveland, Tennessee, United States Formulated Solutions site was formerly Beiersdorf, Bayer, Merck, and Schering-Plough. • Participate in and manage the technical transfer of more than 50 new lotion, liquid, and aerosol formulas and packaging presentations from corporate R&D into the local manufacturing site, including process development, stability/clinical batches, & scale-up. • Execute and manage the pharmaceutical Validation program including Process Validation, Cleaning Validation, and Packaging Validation for… Show more Formulated Solutions site was formerly Beiersdorf, Bayer, Merck, and Schering-Plough. • Participate in and manage the technical transfer of more than 50 new lotion, liquid, and aerosol formulas and packaging presentations from corporate R&D into the local manufacturing site, including process development, stability/clinical batches, & scale-up. • Execute and manage the pharmaceutical Validation program including Process Validation, Cleaning Validation, and Packaging Validation for $500-million cGMP manufacturing site. • Responsible for designing of several systems to maintain compliance requirements and scientific excellence for a diverse Consumer Products facility. Examples include design and maintenance of site-wide Cleaning Validation family program, creation and administration of cGMP major change control system, and representation of the technical side of the site with FDA/ISO/DEA/CHA/ANVISA regulatory inspections. • Improved efficiency and reduced costs with multiple projects relating to equipment cleaning and throughput. Examples are reduced alcohol usage for cleaning and batch change (40% reduction), extended campaigns and efficiency gains in change-overs (20% increase in throughput), and batch size optimizations that reduced change-overs, cleanings, and manpower requirements (10% reduction in product base cost). • Completed program for Merck-equivalent of Six-Sigma Green Belt & Black Belt to accomplish the improvements listed above and others. Also utilized Kaizen and Toyota Kata processes. • Administered a group of up to 14 professionals and multiple validation/scale-up contractors and coordinated day-to-day operation of a long-running Co-Op program with University of Tennessee engineering school students. • Site go-to resource for a wide variety of scientific, compliance, and technical processes, products materials, and systems. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist/Sr. Scientist/Group Leader

  • Jul 1989 - Jul 2001

  Broomfield, Colorado, United States • Formulated eleven bio-equivalent generic solid dosage forms from pre-formulation through product launch. This includes ingredient selection, formulation development, process development, and scale-up. • Lead technology transfer process from R&D to the production floor for the products personally developed. • Managed the Technical Services function for over four years, supervising process validation and production troubleshooting. • Completed coursework for CQA certification and… Show more • Formulated eleven bio-equivalent generic solid dosage forms from pre-formulation through product launch. This includes ingredient selection, formulation development, process development, and scale-up. • Lead technology transfer process from R&D to the production floor for the products personally developed. • Managed the Technical Services function for over four years, supervising process validation and production troubleshooting. • Completed coursework for CQA certification and helped to train over 50 operations and quality employees in the proper use of Statistical Process Control. • Designed and taught a 2-day course entitled “Pharmaceutical 101” to over 900 employees. This course provided a hands-on experience demonstrating the history, manufacturing processes, and technical challenges of the modern pharmaceutical industry. • Holder of two US patents (5,952,003 & 6,110, 493) for the formulation and manufacture of powder-filled Terazosin Capsules that are bio-equivalent to brand name liquid-gel capsules and tablets to treat hypertension and benign prostate hyperplasia. • Author of technical article, “A Statistical Approach to Blend Uniformity Acceptance Criteria” in Drug Development and Industrial Pharmacy; volume 22, issue 11. Show less



KV Pharmaceutical

• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Research Associate

  • Aug 1987 - Jul 1989

  St Louis, Missouri, United States • Manufacture and packaging of pilot and clinical scale batches of solid and liquid dosage forms including immediate and sustained release products, nutritional supplements, and veterinary supplies. Processes included tableting, encapsulation, granulation, blending, film coating, sugar coating, bottle and unit-dose packaging. • Maintenance of accelerated stability chambers and physical testing of samples. • Administered R&D raw material inventory including DEA regulated materials.