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Pharmaceuticals, Formulation R&D, Oral Solid Dosage Forms
Expert is a Pharmaceutical Formulations Development Scientist, with 6+ years of experience in the pharmaceutical field, tablet capsules, and solid oral dosage forms. He is familiar with the process analytical technology (PAT) tools, design of experiments, and stability studies ICH…
Transport Refrigeration and the Cold Chain
I have been in the Cold Chain and mobile service industry for over 35yrs and have been involved in many projects and innovations in the Cold Chain and in other industries including the telematics sector - pharma transport - monitoring…
Construction Project Management
Results-oriented construction management and owner’s rep professional with 25+ years project management experience utilizing multiple alternative delivery methods on a diverse portfolio of project types ranging from $68K commercial renovations to complex, large scale, multi-site/multi-year capital improvement programs valued over…
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…
Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Manufacturing and Warehousing Facility Layout Planning
With over 35 years of experience, Expert has held the positions of Vice President of Operations, Director of Engineering, and Manager of Industrial Engineering. In addition, as a consultant with international experience, he has completed over 150 projects ranging from…
Confectionery and Chocolate Product Development; Manufacturing Problem-Solving
Expert has over 30 years consulting experience in confectionery and chocolate, in the U.S.A. and in more than 30 other countries. He has 19 years hands-on production and plant management experience in confectionery and chocolate in England and Ireland. Expert…
Packaging Machinery, Automatic Cartoning, Casepacking
He is familiar with the latest in vision technology, progammable logic controllers, servo motors and drives from all the large vendors such as Allen Bradley, Automation Direct, Emerson and Toshiba and how they relate to specific tasks in automation as…
Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance
In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…