Pharmaceutical and Biotechnical Quality Assurance Consultant - Regulatory, GMP, GLP, ISO, ICH, FDA, Drug Development, Manufacturing and Aseptic Processing. PhD Consultant Specialized in New Product Research, Scale-Up, Compliance, Production Development, New Applications and CommercializationPharmaceutical and biotechnical quality assurance.Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.Managing multiple projects and complex priorities.Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.Focused AreasProduct releaseProduction batch recordChange controlCommissioning,...

Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

Pharmaceutical, Biotech, Diagnostics and Drug Discover, Commercial Development and Medical Device ProfessionalProduct development programs and projects.Analyze markets, align technology solutions with healthcare market needs, develop insights and business strategy for future customer needs.Develop initiatives programs and drive action plans.Defining and executing winning strategies for successful business growth through deployment of strategic directions, risk management and operational excellence techniques.Pharmaceutical, biotech, diagnostic,and drug discovery.CROs, and medical device markets working within matrix team(s) to identify op...

Bioengineering Consultant with Expertise in Parental Products, Vaccine Production, Protein Purification (Recombinant Protein), Scale up - Downstream Processes, CMC, IND and IMPDPharmaceutical drug development, regulatory affairs, and commercial manufacturing of biologics and combination products.Recombinant proteins of different classes, vaccines, plasmids, small molecules, and combination products involving controlled release formulations.Preform scale up of downstream processes.Development and optimization of protein purification in the recombinant protein production.Regulatory requirements for biopharmaceutical development and manufactu...

Accomplished chemist and regulatory professional for Pharmaceutical and Biotechnology industries. Pharmaceutical Development Services, CMC and Analytical Chemistry, QC, INDs/NDAsAccomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).CMC programs for oral, inhaled, topical and parenteral dosage forms.Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufactur...

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...

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...

Pharmaceutical Operations - Small to Mid-Sized Companies, from Technology Transfer through Packaging and Distribution, and with Companies Under Regulatory or Financial DuressLife sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.ServicesLean Six Sigma Black Belt.Pharmaceutical manufacturing.Pharmaceutical process engineering.Pharmaceutical continuous improvement.Quality engineering and quality systems.Quality Systems Implementation.Cont...

Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...

Biopharmaceutical Industry Consultant - Computational Technology, Therapeutic Areas; Immunology, Oncology Delivering Clinical Candidates, Structural Biology and Medicinal Chemistry.Biopharmaceutical industry leader-small molecule and antibody drug discovery.Structural biology and medicinal chemistry.Broad knowledge base- hands-on; advanced computer simulations and biology, create, lead projects, identify unseen opportunities. Internal and external collaborative projects.Analysis-evaluation for Pharmaceutical licensing opportunities.Pharmaceutical due diligence, target-technology assessment.Align drug discovery and technology validation eff...