Drug Quality and Compliance Expert in Analytical Chemistry, Drug Stability, Out of Specification Investigation, Manufacturing Change Control and cGMPSummaryPharmaceutical quality and compliance, analytical method development and validation.Interpretation of changing regulations.Thirteen years of pharmaceutical industry experience operating within both GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) environments that included eight years of pharmaceutical research and development, hands on technical and research experience, in analytical method development, validation, and application and five years of technical and...

Aerosol Expert for Performance Studies and Regulatory Agency Compliance, Including Quality Assurance of OTC Drug Products.Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.Quality assurance, control and regulatory with experience in manufacturing OTC drug products.Communication and compliance with FDA, EPA, CARB.Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.Undisclosed Company, Quali...

MD with expertise in neurosciences and brain imaging, with extensive experience in medicine, clinical research and analysis including GCP regulations and specializing in clinical neurology, radiology and pathologyA practicing Medical Doctor with 10 years of experience in neurosciences, five years in nuclear medicine, and one year in molecular biology and pathology.Assessments of brain trauma patients, disability cases, for the insurance industry.Extensive experience in data analysis of PET, SPECT MRI, fMRI, and EEG with source localization.Extensive experience in medicine, clinical research and analysis including GCP regulations, specializ...

Medical Device Design and Product Development Expert Specializing in Class III and Class IIb Devices (Coronary and Peripheral Bare Metal Nitinol, SS, Cobalt Chromium and Drug Eluting Stents and Balloons, Scoring Balloon Catheters, Vascular Grafts, Hemodialyzers)Medical device design, product development and commercialization experience of 21 years with a record of building and leading high performance product development teams, developing and commercializing new products, and driving increased revenues and profitability.Successful track record in large (Medtronic, Baxter) and start-up (AVE, AngioScore, NanoVasc) corporations.Research, prod...

GMP, ISO Quality, Compliance, and Audit Expert for Pharmaceutical and Medical DevicesGMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.Document control, training, supplier and quality assurance.Auditing, document control, training, supplier and contract quality assurance.Process validation and contractor managementQuality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Inject...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

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...

Ph.D. Chemical and Biochemical Engineer Specializing in Cell Culture and Sterile Drug Product Process Development, Technology Transfer, Scale-up, and Manufacture.Fermentation and cell culture development, scale-up, and manufacture.Sterile drug product development, technology transfer, and manufacture.Current good manufacturing practices (cGMP).Metabolic modeling.Educator for undergraduate Bioengineering program and workshop facilitation.Undisclosed Company, Owner, 2011 - PresentPr...

Synthetic Drug Product Development Expert - Marketing and IP Management, Including Qualification of Drug Product Manufacturers and Preparation of Regulatory FilingsMore than 30 years leadership in the pharmaceutical and chemical industry.New compounds and discoveries in chemical processes.Expertise in the chemistry of vitamin D and analogs, anti-infectives (macrolides, quinolones, HIV protease inhibitors), taxanes, peptidomimetics, and other anticancer drugs, steroids, prostaglandins and cannabinoids.

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,...