Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

Ph.D. Biochemist Specializing in Agrochemicals, Biomass, Biofuels, and InsecticidesLife science industrial biochemistry and biotechnology technical and strategic problem solving.Insecticide and agrochemical discovery and optimization.Biomass to biofuels enzymes, pretreatment and associated technologies.Renewable chemicals.Accelerated food pathogen detection technology.Undisclosed Company, Proprietor, PresentAgriculture, agrochemicals, renewable chemicals and life science.Serving domestic or international clients.Technical problem solving, project or strategi...

Ph.D. Chemical and Biochemical Engineer Specializing in Cell Culture and Sterile Drug Product Process Development, Technology Transfer, Scale-up, and Manufacture.Fermentation and cell culture development, scale-up, and manufacture.Sterile drug product development, technology transfer, and manufacture.Current good manufacturing practices (cGMP).Metabolic modeling.Educator for undergraduate Bioengineering program and workshop facilitation.Undisclosed Company, Owner, 2011 - PresentPr...

Biotechnology Expert with Extensive Domestic and International Product and Process Development Experience in Pharmaceutical, Biofuel, Chemical, Agricultural and Nutraceutical IndustriesConducting and directing product, process and manufacturing development activities for biologically-derived materials used in the pharmaceutical, biofuel, chemical, agricultural and nutraceutical industries.Production of biosimilars, monoclonal antibodies and industrial recombinant proteins. Activities include research, development, production, biocomparability, technology management in CMOs, FTO landscape critical for biosimilars, licensing, business deve...

Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

Ph.D. Biochemist Specializing in Immune Response and Ph.D. Biochemist Specializing in Immunology and Vaccine Development Against Emerging and Neglected Infections, M.D. Hematologist Specializing in HIV/AIDS, Child Abuse - Neglect and Global HealthMore than 17 years' experience in the fields of immunology, infectious diseases, cellular biology and clinical research.Vaccine development and validation.Immunoassays development and validation.Disease-specific biomarker research.Infectious diseases research and development, in particular in Virology (HIV and Dengue virus), including clinical interventions.Inflammatory response research and devel...

Cell Biology and Repair Consultant with Three Dimensional Models of Miniaturized Tissues for Drug Screening and Animal Models of Cancer and of Diseases Related to Protein FoldingSpecific focus in cell-based assays with primary cells, tissue-based assays, three-dimensional cultures and tissue bioengineering.Adult stem cell technology and tissue regeneration.Tissue bioengineering.Mouse models of cancer; cancer cell biology.Cellular chaperones and co-chaperones.Cell based assays and analytical method development.In vitro 3D models of disease for drug screening.Melanocytes and melanoma.Keratinocytes formation and function.Biology of hair folli...

Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

Oncologist specializing in Biomarker Discovery through Molecular Biological Techniques and High Throughput Genomic/Transcriptomic Solutions, Specifically ncRNA and miRNAMicroRNA and ncRNABiomarker discoveryHigh throughput genomics and transcritptomicsCancer (hematological malignancies and solid tumors)Molecular biologyBioinformatic analysis and pipeline developmentProject managementClinical liaisons and clinical trial developmentBiomedicine MicroRNA and ncRNABiomedicineUn...

Recombinant DNA E. Coli Fermentation Development Expert Specializing In Fermentation, Scale-Up, Technical Transfer and ValidationDevelopment of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Scale up of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Technical transfer of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Validation of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.