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More than 20 years' experience in the fields of molecular and cellular biology, immunology and infectious diseases.14 years' experience in the biotechnology and pharmaceutical Industry.Assay development and drug discovery/development specifically for immunology and autoimmune diseases.Immunoassay development and validation to support PK/TK/Immunogenicity studies.Biotherapeutic drug development.Biomarker research and development.Autoimmunity, immunology and inflammation research and development.Genomics.Infectious diseases research and development.Undisclosed Company, Director Immunochemistry Services, 2006 - PresentHead of staff of 76 runn...
Analytical chemist specializing characterization and analysis of unknown materials, laboratory operations and REACH compliance, Certified Quality Auditor, CQA,Specialize in the analytical in-process / laboratory problem resolution and cGMP auditing / compliance and gap analysis of pharmaceutical suppliers.Process analytical technology solutions and project management.Preparations for REACH compliance in the European Union (EU).Established a satellite pharmaceutical testing laboratory in Hyderabad, India.Pharmaceutical ingredient supplier (cGMP) auditing (ASQ-CQA) including quality systems and regulatory affairs.Qualification of Asian sun...
Electrical Engineer Consultant: Electromagnetic Technology, Field Wave Propagation, EMI Shielding and Device ImmunityElectromagnetic technology, field wave propagation and device immunity and electromagnetic wave shielding.Product design in automotive, terrestrial broadcasting and consumer electronics.Wireless RF/microwave transmitter and receiver design for digital TV broadcasting.Hybrid data encoders and decoders.Software radio system architecture and modular design.EMC and EMI, (electromagnetic capability and electromagnetic interference) analysis, immunity and RF radiation testing with field propagation analysis.RF/Microwave 0 to 12GH...
Urethane chemist with experience in specialty films, corrosion inhibitors and chemical trade with China.Chemical product commerce with China.Polyurethanes chemistry - polyurethane flexible foam production based on polyether and polyester polyols.Specialty films production by the solvent band casting process.Corrosion inhibitor production; specialty chemical production and sales; and production of artificial sweeteners.Operations, new product formulating, research and development.Plant and chemical process shut down.OSHA, EPA and regulatory compliance in chemical plant operations and chemical plant shut down.Increased profits after restruct...
Consultant for API Synthesis and Development and New Business Development in the Pharmaceutical IndustryResearch, development and manufacturing of active pharmaceutical ingredients (API).Operation of contract manufacturing organizations (CMO) serving the pharmaceutical industry.Start up of new business in the global pharmaceutical, biotech and healthcare industries.Experienced with pharmaceutical compliance issues related to health, safety, environment and quality regulations.Senior management positions with record of business unit revenue growth rates of 30% - 75% while controlling the cost base.Driver of continuous improvement, major cha...
Expert in Photocatalysis, Zeolite, Zeolite Synthesis and Purification of Materials with Catalysts, VOC, ZnO, Aluminosilicates, solid acid catalysts.Photocatalysis for volatile organic compound (VOC) decomposition.Gas separations and purification using microporous solids.Zeolite catalysis and zeolite synthesis.Photocatalysis of ZnO and GaN solid-solutions.Titanium dioxide (TiO2) as a photocatalysts.Photocatalysis with ETS-10 materials.Aluminosilicates as solid acid catalysts.Preparing methlamines acidic molecular sieve catalysts.Characterization of advanced nanoporous materials.
Consultant on Human Cell R&D, Cell Culture, and Production of Mammalian CellsCulture of established cell lines (attached or in suspension) for production of biologicals, such as CHO cells and hybridomas.Design and optimization of cell culture media with emphasis on the development of animal component-free formulations for biopharmaceutical applications.Scale up and process optimization of mammalian cell cultures from research and development to pilot production.Application of design of experiment software to the development, scale up and optimization of cell culture processes for increased productivity and reduced costs.Research and devel...
Molecular biology consultant expert in pharmacology, oncology, endocrinology with expert witness and interpreter of scientific literature experience.Pharmacology: Mechanisms of drug action and side-effects.Oncology: Specializing in breast cancer, endocrine regulated cancers and lung cancer.Endocrinology: Hormone replacement therapy with estrogens and progestins.Steroid receptors, steroid hormones and mechanisms of action.Dose-response curves: Tamoxifen, raloxifene, fulvestrant, SERMs, letrozole, anastrozole, exemestane and aromatase inhibitors.Molecular biology, biochemistry, biophysics.Recombinant DNA technology, PCR, mutagenesis, cl...
Expert in Drug Stability, Drug Chemistry, Drug Development Test Method Development, Data Management, Outsourcing, Technical Training and Regulatory ComplianceDrug stability: Pharmaceutical analysis and validation and transfer.Technical knowledge across multiple disciplines of drug development.In depth knowledge of drug stability, cGMP/GLP and method development and validation.Experience with current FDA regulations and compliance, ICH, and global requirements, cGMP/GLps, CMC, IND, NDA, sNDA and annual reporting.Experienced addressing commitments related to FDA Consent Decrees.National and international oral presentations on "Stability" an...
Engineering Consultant Providing Transportation Planning for Federal Transit Administration, Airport, Bus, Rail and Ferry Terminals, People Movement, Toll and Bridge Management.Mass transportation planning, transportation engineering and related project management.Transportation experience with rail, bus, truck, bridge, terminal and people movement (escalator and elevator) systems.Management of certification and maintenance programs for a major mass transit system.Project management oversight for Federal Transit Administration (FTA) projects.Success in winning and managing major, multi-year, transportation contracts.Experience with toll ro...