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IT: Software Consulting, Manufacturing and Supply Chain (Warehouse and Inventory) Management and Traceability, and CGMP
Expert is an operationally focused, multi-disciplined, senior IT professional specializing in the installation and/or project recovery of complex/multi-dimensional manufacturing and supply chain-related systems and equipment. He is highly technically and operationally but with the abilities experiences, and temperament needed to…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production processes he…
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…
Concentrated Apple and Fruit Juice Production & Plant Management, Process Design, R&D
M.S. degree in chemical engineering, 27 years of experience in R&D, process design, quality systems and plant management mainly for concentrated apple and pear juice production, but also grapes and peaches. Responsible for processing more than 1.3 billion tons 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…
CGMP,Pharmaceutical Manufacturing and Operational Excellence
Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…
Bioprocess Development
Expert specializes in the development and selection of recombinant protein expression platforms, translating discovery candidates into development programs and the generation of preclinical material. She has successfully built infrastructure, incorporated process improvements and identified innovative approaches for development. She effectively…
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
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…