Pharma DMFs Compilation, Review and Filing in Various Regulatory Authorities and Marketing Procedures (CP/DCP/MRP/NA) i.e., Europe, EDQM, USFDA, TPD-Canada and TGA-Australia with Accordance to Filing Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries. USDMF: United States Drug Master File, (Open and closed part). Certificate of Suitability (CEP-COS) of EDQM. eCTD Compilation. DMF-Life cycle management. Technical Packages for Pharma Intermediates. DMF review as per ICH guidance. Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Interme...

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

SME Level Chemistry Professional in Area of Chemical Sensors, Ion Mobility Mass Spectrometry Devices, Raman Imaging Devices, CBRNE Detection and Illicit Drug Analysis Summary  Technically accomplished Chemical, Material Analyst and analytical instrumentation. Provide soundness applying wide variety of material analysis techniques; including but not limited, chromatography, spectrometry, spectroscopy and thermal analysis to solve real-life chemical detection scenario.  Hands on with new product development, sustaining existing products, qualification, customer service and application support. Proven leadership ability to effecti...

Ph.D. Chemical Engineer, Focusing on Energy Alternatives, Process Engineering, Start-ups, Profitability Intellectual Products and Management Consulting ExpertAlternative and renewable energy: Bio-ethanol from vegetable starch or sugars (corn, sugarcane, high dry-matter tubers, sugar beets), bio-Diesel fuel from triglycerides (virgin and used vegetable oils) and algae, bio-fuel and animal feed co-production, renewable diesel fuel, solar thermal and renewable electricity from wind, photo-voltaic, bio-gas, biomass/municipal solid waste. Energy storage: Batteries, pumped hydro, hot/cold water storage, compressed or liquefied gas storage wit...

Expert in Polymers, Plastics, Materials, Plastics & Adhesives; Solving Challenging Industry Problems Resulting in Sales Exceeding $2 Billion.Summary Ph.D. Chemist, Scientist and Executive in chemical and polymer industries with broad a range of experience including research and development, intellectual property, manufacturing, and business development. Specific focus to polymers, plastics, materials, composites, adhesives, coatings, and failure analysis. Providing over 30 years of industrial experience as a Scientist, R&D Manager, Director of Research and Development, Chief Technology Officer, and Director of Manufacturing with the...

Water Treatment Support for Government Approvals, Products, Product Nationalization – Standardization and Consulting for Intellectual Property, and Discovery Involving Litigation Issues. Summary Industrial water treatment providing over 46 years in this industry ranging from sales management, new construction and commissioning of thermal systems, laboratory management, governmental, and environmental regulatory compliance, product management, full- service water treatment, marketing, and consulting. Execute product and problem-solving methods for the prevention of scale, corrosion, fouling, and microbiological growth applied to...

Consultant for Pharmaceutical Marketing Research and Drug Program ManagementSenior consultant with 15 years of research experience in academic and industrial settings with a Ph.D. in Immunology.Marketing research of competitive assessment of pharmaceutical market segments and geographical regions.Pharmaceutical and biotechnology drug development, drug company portfolio analysis, strengths, weaknesses and opportunity assessment.Pharmaceutical and biotechnology drug and intellectual property valuation.Clinical trials, FDA filings, product lifecycle management and project management.Experience in collaborating with customers, at different le...