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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…
Materials Technology, Powder Metallurgy, Advanced Ceramics, Process & Product Development, R&D, Lean
25+ years of experience in successfully managing and spearheading R&D and Operations projects to completion. Developed new products and processes, led cross-functional teams, project management and implementation, mentored subordinates and peers, provided team building and leadership, problem solving skills, and…
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…
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…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Formulation Development
Expert has over 20 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms and parenterals dosage forms with leading companies as TTK, Parke-Davis, Strides, Banner Pharma…
Molecular Psychiatry and Neuroscience, Neuropharmacology, Cancer Immunotherapy
Expert has combined his extensive expertise in molecular biology, immunology, molecular neuroscience and psychiatry, and cancer biology to develop a new avenue in the discovery of suitable molecular targets for complex treatment of neurodevelopmental disorders (e.g. ADHD). The new treatment…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Product Development, Delivery Systems, Technology Assessment
Expert is an industrial scientist and formulator with 50+ years of experience in the chemical specialties area with a specialization in health care and beauty aids. He has been associated with Unilever and several pharmaceutical companies including Johnson and Johnson…