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.

Medical Device Consultant with Broad Experience in Business Management, R&D, and Regulatory Compliance: FDA, ISO, CEMedical device product development, market positioning, strategic planning, and branding strategy.Regulatory affairs and compliance, (FDA, ISO and CE approval processes).Technology leader providing equivalent support for the health care, security, intellectual property, and space industries while successfully developing new businesses in the U.S. and abroad.Budget and resource management, contract management and negotiation, change management and restructuring, profit and loss accountability, forecasting and trend analysis,...

National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...

Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...

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...

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 Regulatory Strategy Assessment, Development and Execution for Novel Therapeutics, Interactions with Regulatory Authorities and Regulatory Due DiligenceStrategic regulatory aspects of the development of novel therapeutics encompassing initial registration - approval and life-cycle management of multiple pharmaceuticals (in multiple therapeutic areas).Planning and execution of interactions with regulatory authorities (esp. US FDA).Regulatory due diligence review and appraisal of therapeutic development programs, regulatory aspects in the development of a pharmaceutical for the legal defense.Regulatory due diligence input on po...

Senior Pharmaceutical Professional Specializing in Global Business Development in the Healthcare Industry Focused on: Medical Devices, Drug Development, Regulatory Affairs, Quality, cGMP, FDA, Pharmaceutical and Clinical ResearchSenior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.Global pharmaceutical business development.Regulatory affairs, quality control, clinical research industries and operations.Submission preparation: IND, CTD, ANDA, NDA and MAA.Clinical research including protocol and medical writing.Strategic planning and business analysis.New pharmaceutical development and...

Ph.D. Biochemist Specializing in Protein Purification and CharacterizationProtein purification and refolding.NMR and Crystallography protein purification using LC-MS to characterize proteins.Over 40 years of industry experience in drug developmentCurrent GMPSpecializing in developing new and very effective purification methods.Specializing in assay development.Purification of human insulin and Insulin analogs.Human monocyte/neutrophil elastase inhibitor, developed the expression of MNEI in E coli.Undisclosed Company, President and Founder, 2006 - 2013Acquired facilit...

Research and Development Consultant in the Chemical, Pharmaceutical and Cleaning Industries - Detergents, Special Detergents, Laundry Additives, Bleaches, Surface Care Cleaners and DegreasersResearch and development management in the chemical industry.Product development of laundry products: Detergent and laundry additives.Product development of hard surface products in home care.Project management of consumer goods research and development.Product development of antibacterial consumer goods products.KPIs (Key Performance Indicator) in research and development management.Specific Product FocusActive chlorine preparations containing stabi...