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Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
Medicinal Chemistry/ Synthetic Organic Chemistry-Research and Patent Litigation
Experienced Medicinal Chemist and Consultant: expert at synthetic organic chemistry, pharmaceutical chemistry, pharmaceutical patent litigation, patent analysis: 1) Eight years of consulting experience, beginning in Jan. 2012, writing expert reports following patent analysis covering obviousness, claims validation, enablement; depositions given.…
Bioanalytics, Chemistry
As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
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…
Pharmaceuticals
During Expert’s 30 years in Pharmaceutical Research and Development, he developed extensive expertise in novel drug delivery systems and assessing external drug delivery companies while at Parke-Davis/Warner-Lambert, Pfizer and SCD Pharma Consulting. He also managed a team of scientist developing…
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…
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,…
Intellectual Property, Licensing, Various Technologies & Tech Standards
Expert is the Chief Intellectual Property Officer of a large healthcare conglomerate based in Los Angeles, CA.; Comprised of numerous companies which proudly hold foundational intellectual property in a number of disciplines including by not limited to blood based biopsies,…
Pharma/Biotech Market Access, Pricing & Reimbursement, Business Development Europe and Latin America
Pharmaceutical executive with 17+ yrs. experience in international, corporate and local/regional roles at leading pharmaceutical companies in Europe and Latin America. Strong experience in general management, business development and licensing, alliance management, project and transition leadership, marketing and sales, strategic…