Global Pharmaceutical Creation and Implementation of Systems to Increase Efficiency, Sustain Regulatory Compliance, Interpretation of Regulatory Requirements: Quality Systems, cGMP, Good Laboratory Practices, IND/NDA/ ANDA/ DMF and CAPAGlobal market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manu...

Chemical Process Engineering Expert - Pilot and Production Projects, Including Solids HandlingContributing to over 40 years in chemical engineering working with industry leaders: Dupont, Air Liquide, Day Zimmermann and Hercules.Advanced process technology for research and development organizations in the chemical industry of over 30 years.Led major scale-up from bench through production.Over 20 major start-ups to date totaling in excess of over $75 million in capital equipment. (Bench>pilot> commercial expert).Particle and powder technology: Subject Matter Expert (SME) concentrating on drying, spray drying, grinding, particle morphology...

Novel Nanomaterials Expert with Synthetic Procedures (Colloidal, Wet-Chemical, Solvothermal, Hydrothermal, MOCVD, etc.). Nanoparticle Based Profiling, Targeting, Imaging and Therapy of Cancer Cells, Drug Delivery, Pathogen Mimicking for Immunotherapy and Personalized Medicine.Development and troubleshooting of novel nanomaterials based on synthetic procedures (colloidal, wet-chemical, solvothermal, hydrothermal, MOCVD, etc.).Extensive experience with synthesis of (magnetic, plasmonic, radioprotectant nanoparticles) metals (Au, Ag, Pt, Pd), metal-oxides (MO), metal chalcogenides (-S, Se), and magnetic hybrid composites (M@MO), quantum dots...

Medical Affairs, Medical Writer, and Ophthalmology Expert for Strategic Advisory Boards and Product Launch Medical Writer and Corporate Trainer, Medical-Legal ReviewerCreation of backgrounders and slide sets for pharma and medical device companies.Live training.Medical writing: drug dossiers, medical letters, protocols, abstracts, posters, manuscripts, regulatory writing - CSRs.Creation and administration of Investigator Initiated Study Proposals program.Key opinion leader engagement.Anatomy, physiology, and pharmacology of eye.Methods training for the conduct of clinical trials.Medical-legal review of educational background materials and...

Pharmaceutical Quality Assurance and Regulatory Compliance: GMP, GAP, CMO's, FDA, EU,FDA and EU regulatory compliance.Global quality assurance in the pharmaceutical industry.GMP's - Good Manufacturing Practices.Quality systems, (CAPA, Corrective and Preventive Actions, change control, SOP's, and non-conformance investigations).483's, warning letters and consent decree remediation.GMP's audits, due diligence audits, for cause audits, and mock PAI's audits.Process improvements.Project management.GAP assessments.Sterile products, aseptic process, system simulation tests, HEPA filters, water systems testing, dry and steam sterilization.Soli...

Expert PhD Metallurgist: Mining, Process Development, Energy Reduction, Waste Treatment and Custom Chemicals for Commercial IndustriesProcess development and optimization, through research and development for the chemical, mining, and metallurgical industries.Laboratory services in development processes for primary and secondary metal production, hydrogen technologies, and waste treatment.Reduction processes in energy costs and environmental impact of metal production.Data generation for feasibility of novel process.Reaction mechanisms of commercial processes and new process development and evaluation.Chemical analysisTechno-economic analy...

Pharmaceutical and Biotechnology Medical Affairs Consultant. Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials. Expertise in Ophthalmology, Rheumatology, Dermatology, Cardiology, and GastroenterologyStrategic Advisor and support in in multiple therapeutic areas including: Ophthalmology, Rheumatology, Dermatology, Cardiology, and Gastroenterology.Clinical and Scientific Reviewer of promotional and advertising materials for existing brands, new products, press releases, educational materials, field training materials.Scientific conte...

Polyethylene and Polypropylene (PE and PP) Expert with Process Technology Licensing and Technology Transfer ExperienceSummaryOver 25 years of experience in Polyethylene and Polypropylene (PE and PP), process technology licensing and technology transfer, including:Polyethylene plants start-ups and troubleshooting worldwide.Polyethylene manufacturing operations improvement in licensed plants worldwide.Negotiating sale of new PE and PP licenses and extension of existing licenses.Developing synergistic relationships with multifunctional teams of legal, technical, and business associates to service PE & PP licensees.Chemical IP transfer and L...

Optical Lens Design,Laser Beam Propagation (Single and Multimode, Stray Light Analysis, hologram Modeling, GRIN Media Modeling, Diffraction Analysis, Thin Film Coating Modeling, Modeling of Complex Sources and Detectors, Thermal Analysis and Fiber Coupling AnalysisDesignerLens Designer with Zemax Optic Studio - Professional LicenseSpectrometer designerSmartphone accessory designerHead-mounted display designerPicoprojector designerAnalystStray light analystPolarization analystDiffraction analystThermal analystFocused EffortsFiber optics modeling expert.Thin film modeling expert.Laser beam propagation expert.In-house optical prototyping benc...

Safety, Industrial Hygiene, Security and Environmental Management for Industry and Government Agencies, Specializing in Chemical and Mining SectorsNational and international safety, industrial hygiene, security, and environmental management.SOCMA, including process hazards analysis, management of change and pre-start-up safety reviews, industrial safety and industrial hygiene, fire protection, emergency response both on and off-site, security, product stewardship and environmental issues.New safety and preparedness sustainability programs and waste minimization for various industries.EHS site assessments for safety and health evaluations,...