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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…
PAEK Process Development and Manufacturing
Expert has over 10 years' PAEK experience. During this time, he served as new product development chemist, project leader, and manufacturing manager for PEKK commercialization. As a new product development chemist, he assumed hands-on responsibility for laboratory process and product…
Process Development, Commercialization, Scale-Up; Separation and Purification – Filtration, Activated Carbon
During his career, Expert functioned as a senior-level executive (Senior VP positions) with over 40 years of experience in the Chemical Process and Materials industries. His track record is characterized by: merger and acquisition experience, development of new product lines…
Drug Delivery Technologies;Therapeutic Polymers; Biomaterials
Expert is the Principal and Consultant at a consulting company. The company provides advisory and consultancy services in the areas of drug discovery, therapeutic polymers and biomaterials. He has extensive experience in these areas and co-invented eight therapeutic polymers to…
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…
Radiology, Nuclear Medicine, Nuclear Pharmacy, Molecular Imaging, Patient Safety, Compounding
Director of Radiopharmacy and Associate Professor of Radiology and Medical Physics at a University Medical Center. He is also an adjunct faculty member at several colleges of pharmacy. Expert has expertise in research, development, and clinical use of radiopharmaceuticals for…
Biotechnology (Immunology/Oncology) – Clinical Pharmacology, Pharmacokinetics/Pharmacodynamics
Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of antibodies/antibody drug conjugates Trained in Pharmacokinetics and Pharmaceutical Chemistry, Expert has been working in the leading US biotechnology companies in…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Sustainability, Environmental Chemistry, Water and Wastewater Treatment
Treatability studies and process design for chemical, photochemical and biological treatment of groundwater, wastewater, and leachates. Utilization of respirometric technique for biological treatment of wastewater, soil bioremediation and evaluation of toxic effect of pesticides and heavy metals on biological systems.…
Global Procurement, Chemical Engineering, Manufacturing, Chemicals, International operations,
With over 17 years of experience managing new product development teams, Expert is currently Vice President of Research and Development. He is responsible for strategy, the new product pipeline, project management, resource allocation, product innovation, and intellectual property. His team…