Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...

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...

Organic Medicinal Chemist with Expertise in the Synthesis and Design of Medicinal Drug CandidatesMedicinal Chemist with a proven track record of success in the synthesis and design of medicinal drug candidates.Provide creative and innovative solutions to chemistry challenges including the safe design, conduct, interpretation and technical evaluation.Significant synthetic research experience in multi-step milligram to multigram quantities of intermediates and products, diversity design, crystallographic modeling and experience with protein-protein interactions.Molecule design in partnership with pharmacology and moving projects forward in a...

Seasoned engineer in pharmaceutical, biotechnology and medical devices manufacturing capital projects, processes and facilities compliant with GMP, FDA and ISO requirements.Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.Strategic planning leadership for process impro...

CMC Consultant Specializing in the Development of Small Molecule Therapeutics (Analytical, Chemistry, and Formulation)Physical and analytical chemistry for CMC support of small molecule drug development.Chemical and formulation process development for API and various dosage forms.Material characterization of API and dosage forms for process development and troubleshooting.Analytical development, method validation and transfer for development and commercial methods; data analysis and interpretation of trends.Coordination of CMC activities with toxicology, clinical, QA/QC and regulatory affairs line functionsProject and supply chain manageme...

Expert in applied statistics, biostatistics and mathematics - designs analyses for clinical trials, pharmaceutical exposure and efficacy, Medicare/Medicaid effectiveness and learning methodologiesClinical trials protocols, statistical analysis plan and clinical study reports.Bayesian inferential and decision analysis.Integrated Analyses of Efficacy and Safety.Due diligence.Pharmaceutical adaptive designs: blinded and un-blinded sample size adjustment, group sequential designs.Clinical trials sample size determination.Mixed models repeated measures models.Pharmaceutical product exposure modeling.Statistical programming in SAS (MACROs, IML,...