Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Executing 30 years in Safety, Health and Industrial Hygiene Management for Various Industries: Paper, Packaging Manufacturing, Petrochemical, Telecommunications, Brewing and Rubber Consulting.Industrial hygiene management providing over thirty years of experience with focus to safety and health management. Establish safety management systems supporting culture changes, applying safety engineering, training, OSHA negotiation and program development. Providing solutions to reduce workman’s compensation claims. Excellent communicator with technical, written and verbal skills, and providing expertise in the following industrial industri...

Food Consultant for Food Process and Start Up. Product and Process OptimizationFood Process and Product DevelopmentDeveloping new food formulation and new food processes.Development of formulation and processes for non-fruited bakery fillings, icings, toppings, and release agents; coffee and juice; peanut butter; fruit strips and ropes, nutrition bars, protein gummy bears, protein fruit strips.Experience in fats (lipids), emulsifiers, sugars, proteins, maltodextrins, sugar alcohols, starches and gums.Expert testimony in legal cases such as companies suing each other over a product failureExperience in USDA actions shutting down operations...

Laboratory, Plant Operations, QA/QC Management, Compliance and ExpertCertified chemist with focus in oil, water and gas analysis, including research, product testing, in-process control, production planning, process operations, statistical quality control, experimental techniques, product development and technical documentation.Laboratory operation and Quality Control Management-QCM.Environmental consulting and sampling techniques.Plant startup and analysis for the oil, water, steam plants and facilities.Laboratory method validation and SOPs modification.SOPs modifications, method validations, author work instructions and critical task as...

Display Technologies Expert: System Considerations and Optical Aspects. AMLCDs, Backlights, Avionics and Industrial Displays, Touch, New Technologies; QD, OLED, Micro-LEDs, 3D Displays, Medical DispSummary Committing 25 years’ experience in display technologies in the domestic and international commerce with focus to military, avionic, medical and industrial displays environments.  Promoting optics development, an avid author of many publications, and inventor of numerous patents. Display technologies and systems. Active Matrix Liquid Crystal Displays, (AMLCD) development and backlights. Touch technologies. Color science, p...

Risk Management Consulting in Business Continuity Planning, Management, Testing for Small and Mid-sized Businesses Throughout the United States and Internationally. Business continuity Disaster recovery Financial technology controls Financial technology problem management Risk management Technology control Compliance: Federal Deposit Insurance Corporation (FDIC) and European  Pharmaceutical Research Association (PRA)  Standards. Cyber security Digital product management Financial customer service Project management Agile methodologies Microsoft and Google applications Rally

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...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...

Ph.D. Biochemistry Food and Nutrition Expert. Food Emulsion Biochemistry and Physical Chemistry, Fermentation and Coagulation within Non-Dairy SystemsNutritional food and beverage product development, bridging between chefs, food technologists, protein chemists and biochemists, and executives.Industry research planning, methods development, rapid prototyping, product development management and troubleshooting, patent applications, product upscaling, co-packer and business-to-business relations, and brand ambassadorship to both businesses and consumers.Product-specific reduction and elimination of eggs and dairy ingredients in a variety o...

Polymer Scientist Working in: Polyurethane Applications, Polymer Foams, Polyurethane Dispersions, Coatings, Adhesives and Elastomers, Rigid foam formulations, Urethane Acrylates -Coating ApplicationsSummary Polymer Scientist that is creative, a problem-solver, strategic, with expertise in developing and commercializing of new products and intellectual properties for polyurethane applications, including polymer foams, polyurethane dispersions, coatings, adhesives and elastomers.  With a career resulting in many publications, under 100 patents, and a variety of commercial products that have generated more than $100 million in revenue....