Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and ExpertRadiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation. Oversee fast-paced radiopharmacy production environment. Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry. Demonstrated extensive and consistent...

Medical Device, Medical Drug Delivery Design and Development for the Biotechnology and Pharmaceutical IndustriesAccomplished engineer/scientist with over 35 years’ experience in the design and development of drug products, pharmaceutical manufacturing processes and medical devices. Successful track record of progressing products from lab bench to commercialization. .Technical Competencies Drug product development and characterization, Process development and scale up, Project management, Identifying and managing vendors, CROs, CMOs, Tech transfer & trouble-shooting, Authoring CMC regulatory submissions, Development of micro-...

Analytical chemist expert in development, validation and transfer of methods for pharmaceutical regulatory filings such as IND, ND, NDA, eCTDSeparation science HPLC, ion chromatography, chiral HPLC, GCAnalytical method development and validation analytical method technical transferLaboratory equipment and instrument qualification and calibrationDesign and setup of GMO and GLP Analytical LaboratoriesRaw material and drug substance characterizationPhysical chemical characterization and structure elucidationProject management for bioanalytical and analytical laboratoriesBioanalytical method developmentQuality assurance for GMO and GMOP labora...

Biologics Pharmaceutical Development and Manufacturing Consultant for Clinical and Commercial Products. Formulation Development Work and Stability Testing, from Early Stage Through Commercial, for Proteins, Monoclonal Antibodies, Vaccines and Small Molecules.Biologics pharmaceutical development and manufacturing, working in process development, purification, formulation, lyophilization, analytical development and stability for both clinical and commercial products.Formulation development work and stability testing, from early stage through commercial, for proteins, monoclonal antibodies, vaccines and small molecules.Sterile fill support f...

Seasoned engineer in pharmaceutical, biotechnology and medical devices manufacturing capital projects, processes and facilities compliant with GMP, FDA and ISO requirements.Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.Strategic planning leadership for process impro...

Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

Senior pharmaceutical R&D professional focused on analytical methods, methods validation, validation of computer systems and quality assurance and quality systems. Experience with parenterals, liquids, solids and semi-solids.Analytical Techniques: GC, HPLC, GC/LC/MS, FTIR, UV-Vis.Stability-indicating method development, validation and transfer.Analytical equipment validation: IQ, OQ, PQ.Part 11 compliance and GAP analysis.Validation master plan development.Stability protocol development.CTD dossier preparation.Cleaning validation strategy.LIMS and Laboratory Data Acquisition Computer systems.Coumadin, Percodan, Naloxone, Numorphan and N...