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Formulation Liquids, Soft Gelatin, Two-piece Hard Capsules, and Process Development in Pharma
Expert has developed Soft Gelatin Capsules containing non-aqueous solution, suspension and self-emulsifying formulations for a variety of new chemical entities (NCE), prescription, highly insoluble compounds and OTC drugs. This experience included conducting solubility studies with hydrophilic/lipophilic excipients, as well as…
Recycling, Scrap Metal, Paper, Plastic, and Rubber
Expert has almost 40 years of experience in the recycling and scrap processing industry. He spent the first 15 years in senior management at scrap processing companies, where his vast responsibilities included operations, sales, marketing, quality control, environmental compliance, and…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Pharmaceutical Discovery and Preclinical Development
SPECIFIC PRODUCTS IVIG (Gammar-P IV ) Rhone Poulenc Rorer Marketed AMP – 579 Rhone Poulenc Rorer Phase II Fenofibrate (TriCor) Abbott in-licensed from Fournier. Over $1 Billion in annual sales. ABT-538/ABT-378 (Kaletra) Abbott over $1 Billion in peak annual sales…
Polymers, Plastics, Composites, Plastic Pipe, Composite Pipe, and Failure Analysis
Throughout his 41-plus-year career experience in the plastics industry, Expert has worked in research and development, product development, technical services, application development, failure analysis, sales, marketing, market development, business development, R&D management, small business unit management, trade association management and…
Non-GMO Seeds, Commodity Exports, Asian Grain Trading, Food Grade Agricultural, IP Handling, Bulk Grain Brokering, AgTech
Oversaw five R&D seed breeding programs focusing on soybeans and corn as well as specialty non-GMO, food grade, and industrial varieties. Managed three different multi-commodity export trading/merchandising business units (two of which were foreign-owned by Asian trading companies). Developed numerous…
Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production processes he…
Lighting: Components and Systems, Field and Accident Investigations, Codes and Standards
Expertise in virtually all technical, business and legal aspects of lighting. Consulting services include lighting systems, lighting controls, accident investigations/field issues, and codes and standards. A specific field of expertise is in the technical and legal review of metal halide…
Lifting, Supporting and Elevated Access Equipment
Expert services covering lifts, hoists, jacks, cranes, industrial machines, hydraulic equipment, tools, material handling, fork lifts, aerial work platforms, loaders, automotive lifts and scissors lifts. Forty plus years of engineering, manufacturing and management experience to provide services relating to product…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…