Ph.D. Cellular & Molecular Medicine Consultant with Expertise in Pharmaceutical Development, DNA and RNA Sequencing, Translational Research and Clinical Trial Development SpecialistPreclinical pharmaceutical development and therapeutic analysis in rodents.Investor due diligence of preclinical data.Cancer genetics, genomics, epigenetics, and epigenomes.Bioinformatics.Genetically engineered and transplantable animal models of disease.High throughput and next generation DNA and RNA sequencing.Genome engineering using CRISPR.Molecular biology and pharmacology.Biomarker development and testing.

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...

Pharmaceutical Microbiology Quality and Regulatory Consultant with Expertise in Process Validation, Steam Sterilization, PDA's, ASQ Certified.Regulatory affairs and quality assurance certified with ASQ.Over Twenty-five year's expertise in sterile process validation, steam sterilization and aseptic processing.Pharmaceutical microbiology, and chaired PDA's Microbiology and Environmental Monitoring Interest Group for over fifteen years.GMPs, data integrity, sterile process validation, steam sterilization, microbiology, environmental monitoring, regulatory updates, and conducting regulatory submissions.Expert Witness ExperienceInternational pa...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Consultant in Computational Modeling. Drug Design, Proteins, Small Molecules, Genetics, Machine Learning, Artificial Intelligence, Bioinformatics and Biomedicine, Materials Discovery, Robotics & ContrSummary  Drug discovery consulting and research and development in Biomedicine. Providing over ten years in biomolecular computational methods (small molecules and proteins, proteomics, genetics).   Drug Discovery and Biomedicine - Health  High throughput virtual screening and docking. Drug candidate identification. QSAR (Quantitative Structure Activity Relationship) and QSPR (Quantitative Structure Property...

Interpretation and Analysis of Technical Intellectual Property Related Documents in English and Japanese. Biochemistry and Cellular Biology Background in Biologics and Small Molecule Drug Discovery and Development. Drug Substance In Vitro Assay Development and StandardizationInterpretation and analysis of highly technical Japanese documents in English.Pharmaceutical and biotechnology research project management.Biochemistry - cellular biology background: Biologics and small molecule drug discovery and development.Liaison and interpreter for licensing and material transfers to and from Japanese organization.Manager of in vitro pharmacol...

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...

Multi-Disciplined Expert Working in the Health, Energy, Environment, Advanced Material-Coatings Industries covering areas in: Biomaterials and Bone Tissue Engineering, Drug Delivery, BiodegradablesSummary Materials Science, Technology and Manufacturing Engineer in Research and Development, (R&D) providing over 27 years of experience working in the industry and academia, Included in Stanford University’s List of World’s Top 2% of Scientists, USA Metallurgy engineering, coatings and corrosion consultancy: Providing graduate level  educational in the STEM area, maintaining a high standard of quality and connecting R&D....

Control Malfunctions in Human and Other. Finding Solutions through Carbon Based Research considering Molecular Forces and Biomolecular Systems. Bioinformatics Computational biology Bioengineering Proteomics Protein science Structural biology PERL programming Biocomputing Nanoscience Computer Biophysical chemistry Undisclosed Engineering College, Karur, Tamilnadu, India Professor, 2018 - Current Teaching and Research Professor - Department of Chemistry, 2014 - 2018 Karunya Univer...