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Food, Cannabis, Quality, Compliance, Edibles, Manufacturing, Processing and Operations
US Navy veteran who found a place in food and regulatory compliance after serving active duty. Experienced in baking, dairy, beverage, confections, chocolates in the food sector for over ten (10) years. While pursuing an MBA (graduated in 2019) pivoted…
HPAPIs, Pharmaceutical
Imaginative and resourceful professional with multi-faceted leadership experience in project/program management and drug development and manufacturing. Possesses key business skill sets including: strategy planning and execution, new product development, negotiation and influencing, and continuous process improvement. Strong technical skills to…
Fire Origin and Cause, Products Liability, Equipment Failure, Management, O&M Evaluation
Expert has performed accident investigation activities and assisted legal staff in preparing for court cases including providing sworn testimony regarding issues of fire and explosion origin and cause, equipment performance, manufacturing processes, and management negligence in personal injury cases. He…
Formulation Science, Formulation Chemistry
Expert is an experienced ‘Formulation Scientist’ offering outstanding Product Development skills for Oral Liquids, OTC Products, Hand Sanitizers, Personal Care Products, Topicals Products, Tablets, Parenteral Products. Expert can also help in modifying existing formula, offer expert guidance on product design,…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Pharmaceutics
Excipients are broadly defined as any pharmacologically inert components other than the active pharmaceutical ingredient (API) that are added intentionally to the pharmaceutical formulations. Unintentional variability in the properties of the excipients may have a range of influences on their…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
Food Science & Technology, Project Portfolio Management, and RD&I
As a food scientist with 25 years of experience in product development and a passion for sharing knowledge, Expert's mission is to help entrepreneurs and businesses overcome those challenges, providing immediate access to food innovation expertise. Experienced in the commercialization…