Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

Physical Organic Chemist Specializing in process Research and Plant Scale Up of Organic Compounds and Polymers, Lab Synthesis of Specialty Polymers and Monomers, Kinetic Studies and Experimental Designs, and Polymer Characterization and IsolationFree radical polymer synthesis including emulsion, solution, bulk, suspension, ATRP (Atom-Transfer Radical-Polymerization).Condensation polymer synthesis including polyesters, nylon, polyethers (Ullmann synthesis).Small molecule organic synthesis (1-4 steps) with emphasis on acrylic and methacrylic monomers.Characterization of organic molecules using standard techniques such as NMR, IR, UV/Vis, mas...

Ph.D. Bioengineering Consultant Specializing in Biomaterials, Electrospinning (Polymer Fibers), Surface Conjugation, Biocompatibility, Microfluidics, Cell Mechanics, Tissue Engineering (Craniofacial Organs)Synthesis of polymer hydrogels for tissue engineering and regenerative medicine.Fabrication of electrospun polymer fiber mats.Polymer surface conjugation with bioactive peptide sequences.Polymer and peptide characterization.Microfluidic laboratory setup for tumor metastasis modeling and kinetic studies.Advanced quantitative microscopy imaging and data analysis.Streamlining molecular biology laboratory operations.Project Management, qual...

Veterinary and Surgical Anatomy Expert with Medical Device ExperienceVeterinary and surgical anatomy in domestic species.Animal and human anatomical variation studies, impacting medical device development and testing in success and failure.Human anatomy.Human and animal physiology, histology and pathology.Canine cardiac anatomy and implications of pacemaker and cardiac catheter use in dogs in veterinary medicine and biomedical research.Human cadaver dissection.Independent Consultant, 2016 - 2017ProjectPreparation of a technical report on the comparative anatomy of the hum...

Ph.D. Engineer Consultant Specializing in Microfluidics, Point-of-Care Diagnostics for Medical Devices for Disease Detection and Infertility DiagnosticsBiomedical engineer developing medical devices and products for early disease detection and infertility diagnostics.Develop microfluidic-based platforms from proof-of-concept through commercialization.Develop micro and nanotechnologies with application in medicine and biology.Expert in developing point-of-care biosensors for infectious diseases.Five years of experience in grant writing (NIH, NSF, DoD, Foundations) (R21, R01, SBIR, STTR).Worked with Human Leukemia, Breast, and Prostate Canc...

PhD Biology Consultant with Expertise in DNA-RNA Identifying and Sequencing, and Analysis of Genotyping and Expression MicroarraysGenomics, bioinformatics and biotechnology.Chip-seq, RNA-seq, DNA re-sequencing and de novo analysis.Analysis of Genotyping and Expression Microarrays.Strong programming experience with Perl, Bash, Java, R, and MySQL.Thorough knowledge of standard bioinformatics tools including UCSC and NCBI.High-performance computing including SGE clusters.Expert Witness ExperienceAnalyzed GenBank and PubMed to identify prior art for the BRCA1 patent litigation.

Ph.D. Oncologist with Expertise in Cloning Studies and Flow Cytomertry Panel Design and Immuno-Oncology Study Design in Humanized MiceImmuno-oncologist in various immunological and flowcytometric assays designs for humans and mice.Flowcytometry: Designing and running panels (both intracellular and surface) using various machines on 4-10 color platforms (BD FACS Aria, Calibur, LSR II, Canto, MoFlo) on human PBMCs, AML samples from patients and mouse cells ex vivo and in preclinical humanized models of mice on NOG platform.Creating and studying in vivo mouse models to analyze T and myeloid cells from humans and mice (RAG/BALB/C57Bl6) for in...

Biological and Biostatistical Consultant Specializing in Molecular Biology, Epidemiology, Genomics, and Application Development for Infectious DiseasesInfectious disease epidemiology, molecular biology, and disease ecology and evolution.Genomics.Bayesian statistical analyses.Bioinformatics.Scientific, technical, grant application, and popular press writing.Biomedical research, application, and development.Microbiology, parasitology, and host-parasite interactions.Diagnostic development.Biosafety level 3.

Educator and Scientist in Forensic Sciences: Biology Nano Technology, Immunotoxicology, Animal Cell Culture, and NonocompositesHalloysite nanotubes, Nanobiotechnology, DNA nanoparticle interactions, Animal Tissue Culture, Primary Culture, Cell cycle pathways, Cell expression, Protein purification, Process developmentComplianceLaboratory Quality System and Internal Audit as per ISO/IEC 17025:-Updated Version and NABL Requirements.Occupational Health and Safety Management System. (OHSMS 18001).Preparation and execution of SOPs.Statistical analysis and evaluation of data routine environmental monitoring of TC lab using microbiological load e...

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...