Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...

Ph.D. Expert Developing Immunology and Molecular Assays, Due Diligence, Gene Editing, RNAi, Automated Cloning, CRO, CMO and IND SubmissionsAssessments and due diligence for funding of synthetic biology companies. Mentor to start-ups within the Biological portfolio to attain seed and series funding.Synthetic biology, specialty chemicals, and nutraceutical products.Develop and execute cell-based, immuno, and molecular assays for release of large molecule therapeutics.Development of assays for large molecule therapeutics from multiple modalities including monoclonal antibodies, antibody-drug conjugates (ADC), T-cell engagers, and small pept...

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.

Ph.D. Materials Scientist Consultant with Expertise in Medical Devices, Biosensors, Implants, Biomaterials and Adhesives.Design and manufacturing of medical devices including implants, orthopedic devices, and cardiovascular devices.Characterization of medical devices and medical device coatings.Synthesis, processing, and characterization of polymers.Biocompatibility of biomaterials, medical devices, and implants.Flexible and biocompatible materials for neurological devices and wearable electronics.Design and characterization of materials for energy storage in medical devices.Electronic biocompatible applications implantable sensors.Expert...

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...

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...

Analysis of Soft Materials Expert Witness Reports and Mechanical Characterization of Soft Matter - Ph.D., Medical Device Expert Experienced researcher with a demonstrated history of project management in academic and industrial settings. Excellent communication and presentation skills in chemistry, materials science, data analysis, and polymers. Measurement of tensile and compressive properties of biomedical polymers and metals. Expert Witness Experience  Aided in characterization and compilation of results for hernia mesh litigation. Prepared data for thesis advisor to serve as expert witness in this litigation.

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...