Canadian regulatory affairs expert prepares pharmaceutical and medical device submissions and audits manufacturing quality practicesPharmaceutical Good Manufacturing Practices (GMP) for Canada.Regulatory Affairs Canada, submission preparation.Change control and complaint management.Pre-approval inspections.Pharmaceutical Quality Systems, clinical trial supplies.Qualification and validation: process, equipment, cleaning and test methods.Water for pharmaceutical purposes.Bioanalysis.Adverse event management; deviation and out-of-specification investigations.Sterile product manufacturing; environmental monitoring.FDA, QA, QC, quality assuran...

Expert in building design, building inspections, HVAC systems and forensic evaluation.Senior mechanical consultant specializing in building inspections and HVAC systems.Forensic examination of buildings including design, reconstitution and building use.Building inspection, building construction and building program management and maintenance.HVAC building controls, refrigeration and utilities.Building engineering and construction.Certified construction inspector.Co-founder and Principal Engineer of EngineeringCompanyOver thirty years designing, engineerin...

Specialist in pharmaceutical research and development, synthesis and scale up of experiments, anti-cancer drugsBiotechnology and pharmaceutical research and development:Pharmaceutical process research and process development.Multi step organic drug synthesis: Route and reagent selections; literature and patent survey of synthetic routes; synthesis of API or API intermediate to ensure non infringing routes.Skilled at the use of Boron reagents.Drug discovery:Strategies for discovery of new Inotropic agents (synthesis of modified Adenosine Monophosphate) for heart failure.Discovery for synthesis of novel prodrug oligonucleotide for Cytarabi...

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...

Chemical Process Design Engineer: Organic, Inorganic, Pharmaceutical and fine Chemical Processes, PFD's, P&ID's, Heat, Material Balances and Equipment DesignChemical process design, engineering, and troubleshooting of organic and inorganic processing plants.Directing process engineering project teams for the preparation of process evaluations, cost studies, preliminary and detailed design, PFD's, P&ID's, heat and material balances, equipment design specification.Heat and material balances (HMB).Equipment scale-up.Polymerization.Hydraulics, distillation, and plant utilities.Vaccine compounding and vaccine formulation.Vial filling Lines.Wat...

Drug Analytical Support Consultant with CMC and Consent Decree ExpertiseAssessing specification and CMC analytical development for pharmaceutical drug substances and drug products.Analytical project planning and strategies for early, mid and late stage development programs.Writing, editing, and reviewing analytical technical reports.CMC and regulatory submission documents for Health Authority and FDA responses.HPLC method development, validation and transfer.Subject matter expert for the isolation and identification of synthetic impurities and degradation product unknowns.Contract Research Organization (CRO) management.Analytical Investiga...

Consultant for Oral Drug Delivery Dosage Forms with Controlled Release and Sustained ReleaseOral solid dosage form formulation and process development.Drug delivery technology for controlled release dosage forms (osmotic, matrix and multiparticulates) and enhancing the oral bioavailability of poorly soluble compounds.Controlled release and sustained release drug dosage forms.Spray dried and hot melt extruded dispersions.Development and application of drug delivery technology.Extensive experience in formulation and process development for controlled and sustained release formulations and poorly soluble compounds for oral delivery.Osmotic sy...

Microbiologist Consultant for Microbial Cell Culture and Fermentation, Process and Equipment Validation ExpertOver thirty years of research, development, QA/QC, technical service, validation, manufacturing and engineering management experience in the food, pharmaceutical and biotech industries.Design, construction, scale-up, start-up, validation and operation of biotechnology and pharmaceutical manufacturing equipment and processes.Validation activities for pharmaceutical processes, for example, in an aseptic fill and finish facility for ophthalmic and parenteral solutions.Microbial physiology, biochemistry and genetic mechanisms controll...

Chemical Consultant for the Synthesis of Protected Amino AcidsSummary: Senior research scientist known for creative, practical and goal oriented work and education in organic chemistry. Extensive experience in pharmaceuticals and fine chemicals research and development and pilot plant design and operation. Research career involves chemical process design, product development and optimization and scale-up of APIs and fine chemicals.Synthesis of steroids and steroidal intermediates, APIs related to hormone replacement therapy (HRT).Synthesis of protected amino acids and amino acids linked to resins.Custom synthesis of protected nucleosides...

Chemical Engineer Consultant: Water, Process Utilities, Sustainable Fuels and Biomass to Energy.Pharmaceutical water system design, equipment, pharmaceutical water standards, P&ID, facilities construction and validation.Process engineering expert with a focus on water treatment facilities, process utilities, sustainable fuels, petrochemicals and biomass to energy.Analysis of construction contracts, engineering claims and engineering standard of care issues for process design and construction.Twenty years of experience in membrane filtration with a focus on pharmaceutical and biotechnology waters, water for injections and purified water sy...