Global Quality Expert for Sterile Injectable and Medical Devices with Extensive Experience Interacting with FDAQuality for small and large volume sterile injectable and medical devices.Quality assurance policies for sterile injectable dosage, and product assurance.Procedures for out of specification (OOS) results for analytical and biological laboratories for sterile injectable dosage.Quality investigation teams to investigate high and medium level deviations to determine root cause, implement appropriate CAPAs and check for CAPA effectiveness.New product development and sterility assurance of sterile disposable products.ISO 9001 certifica...

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 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...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...