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Pharmaceutical Process Research, Development, and Manufacturing
Expert has 17 years experience of research, development and manufacturing of APIs. Expert has three patents from research, development and manufacturing of etoposide and etoposide phosphate. He also has extensive experience with platinum anticancer drugs, including cisplatin, carboplatin, and oxaliplatin.…
Specialty and Fine Chemicals, Pharmaceuticals, Resins, Coatings
He has worked in the process development, manufacturing related to the technologies, chemistries. He has also worked in intellectual property strategy, commercialization of many different technologies. He is able to do this as he has cross- fertilized manufacturing and processes…
Legacy Application Support: Manage, Measure, Improve Using ITIL V3 Service Management Life Cycle
Exper spent 10 years as Director of MIS for the Revlon Health Care, Pharmaceutical Division and managed all IT activities for 5 companies within the division. Major accomplishments were designing and implementing complex pharmaceutical order processing/distribution system and integrating it…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Biopharmaceutical Development
Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most recently, VP of Biologics Development at…
Process Chemistry: R&D, GC, HPLC, Flash Chromatography, NMR, IR, Mass Spec, & LCMS, Synthetics
He has experience with process research and development, including scale-up to 10- and 15-L reactors. Included in his background is experience with the design, execution, and optimization of multi step organic syntheses aimed at both pharmaceutical intermediates and APIs. In…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Pharmaceutical Analytical Chemistry, Cosmetic Analytical Chemistry, Mathematics, General Science
Expert is a retired chemist with over 35 years of experience in the cosmetic and pharmaceutical industries. He evaluated and dispositioned all raw ingredients used in manufacturing cosmetics and OTC cosmetics. He developed a reduced testing program to improve efficiency…