Medicinal Chemist Specializing in the Design and Synthesis of Antibacterials and other Antiinfectives. Drug Development and Project Management from idea to Clinical Trials.Antibacterial chemotherapy including beta-lactams, quinolones, DNA - gyrase and top IV inhibitors, peptide antibacterials, pleuromutilins, glycopeptides, oxazolidinones, 2-component signaling, natural products, single enzyme targets such as the Fab and Mur proteins, GlmU, LpxC, and mechanism based small molecule inhibitors projects.Antiviral chemotherapy: HIV and Herpes antivirals, HIV protease, HIV integrase, HIV-NCp7 (nucleocapsid protein).All aspects of medicinal che...

Doctorate in Environmental and Occupational Health (with dual certification, Industrial Hygienist (CIH) and a Certified Safety Professional). in Pharmaceutical Exposure-Control, Exposure Assessment Strategies, Analysis of Industrial Hygiene Data, Ventilation Engineering and Indoor Air QualityIndustrial Hygienist (CIH).Certified Safety Professional - air quality evaluations, noise analysis, and safety programs.Exposure assessment.Analysis of industrial hygiene and exposure data.Pharmaceutical exposure control.Local exhaust ventilation.Indoor air quality.

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Senior pharmaceutical R&D professional focused on analytical methods, methods validation, validation of computer systems and quality assurance and quality systems. Experience with parenterals, liquids, solids and semi-solids.Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.Stability-indicating method development, validation and transfer.Analytical equipment validation: IQ, OQ, PQ.Part 11 compliance and GAP analysis.Validation master plan development.Stability protocol development.CTD dossier preparation.Cleaning validation strategy.LIMS and Laboratory Data Acquisition Computer systems.Coumadin, Percodan, Naloxone, Numorphan and N...

Extensive experience in toxicology, pharmacology, product safety, and regulatory standards.Consulting in toxicology and product safety evaluation and assessment to the following industries: OTC drugs, pharmaceuticals, cosmetics, personal care products, chemical household products, medical devices and biotechnology.Establish and manage product safety compliance, regulatory standards and approvals.Design and manage safety evaluation and toxicology research programs that meet industry standards and are successful in achieving regulatory approval.Consultation and scientific support for product liability and toxic injury.California Proposition...

Protein engineering and protein evolution related to drug resistance and molecular toxicologyRandom mutant library generation.Protein engineering.Mutagenicity assays, (Ames' test).ColE1-based plasmid regulation.DNA repair, specifically repair of reactive DNA methylation.Drug resistance: targets, evolution.Microbial genetics.Molecular pharmacology.Molecular toxicology.Undisclosed University, Assistant Professor, 2007 - PresentHead of a research team including a senior scientist, technician, graduate student and several undergraduate assistants.Obtai...