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Pharmaceutical Consultant: Analytical Methods Validation, Computer Systems Validation and QA/QC - Technical Consultant #1026

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...

Expert consulting on mammalian and bacterial cell bioprocess, cell cultivation, cell purification and cell characterization. - Technical Consultant #1384

Expert consulting on mammalian and bacterial cell bioprocess, cell cultivation, cell purification and cell characterization.Cell culture/bioprocess, protein expression, protein purification, and surface sciences.Significantly improved recombinant protein yields (>10x to >1 g/L) in E. coli cultures by rational medium design and bioprocess optimization.Extensive cell culture experience for a wide range of cell types (e.g. mammalian cell lines, primary cells, bacteria and fungi).Specialized in cell selection, cultivation, characterization and recovery.Protein purification processes and protein purification strategies.Expertise spans from upst...

Validation and Regulatory Pharmaceutical Consultant - Technical Consultant #1431

Developing and validating standards for pharmaceuticals and biopharmaceuticals. Technical and regulatory aspects of pharmaceutical and biopharmaceutical development and manufacturing including analytical and bioanalytical characterization as well as stability testing and formulation development. Audit and FDA experience.Developing and validating standard and state of the art analytical methods to characterize pharmaceuticals and biopharmaceuticals.Expert in liquid and gas chromatography, capillary electrophoresis, spectrophotometry and mass spectrometry (single and triple quad and MALDI and ion - trap).Developing and validation of biologi...

Analytical Chemistry Pharmaceutical Consultant for Good Laboratory Management and FDA Compliance. - Technical Consultant #1602

Pharmaceutical Analytical Chemistry Consultant for Good Laboratory Management and FDA ComplianceGMP auditing of companies in U.S, Europe and Japan.Data integrity audits of quality assurance and quality control.Remediation of quality operation GMP inspection observations.FDA and foreign agency interactions by written response for applications and direct meetings for applications, inspections and other agency meetings.Successful FDA preapproval inspections of analytical lab.Successful FDA GMP and GLP inspections.Analytical method development, validation and method technical transfer.Separation science HPLC, ion chromatography, chiral, GC and...

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development and IND - Technical Consultant #1778

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development; IND Filing, Support of Phase I & II Clinical TrialsSynthetic and medicinal chemistry.The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.18 years o...

Analytical Chemistry, Drug Stability and Out of Specification Investigation - Technical Consultant #1790

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...

Bioanalytical, Microfluidic, and Nanotechnology Instrument Development Expert - Technical Consultant #1811

Scientific Engineering Consultant Specializing in Device and Instrument Development, Method Optimization in Bioanalytical, Microfluidic, and Nanotechnology ApplicationsDesign of microfluidic devices and instrumentation for analytical and forensic analysis.Development of biological sensor and methods for protein and DNA detection.Development of miniaturized methods for processing of biological samples.Integration of novel technologies to new applications and processes.Scientific writing for grant proposals and other scientific publications.

Analytical Chemist for Pharmaceutical and Biopharmaceutical Product Development and Validation - Technical Consultant #1906

Analytical Separations Scientist for Pharmaceutical and Biopharmaceutical ApplicationsAnalytical chemistry and biochemistry.Analytical biotechnology and biopharmaceutical regulatory science.Analytical method development and validation.Separations science and mass spectrometry.Thermal stability studies of immunoglobulins.Separation and quantitation of monoclonal antibodies in cell growth.Validation of chromatographic methods.Derivatization approaches for a fermentation derived, cyclic peptide analog.HPLC - High Performance Liquid ChromatographyUPLC - Ultra Performance Liquid ChromatographyGC - Gas Chromatography or General ChromatographerSF...

Life Science Industry Expert: Pharmaceutical Business Development, Drug Development and Portfolio Management - Technical Consultant #2045

National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...

Biotechnology Industry Expert: Pharmaceuticals, Drug Development and Drug Therapy; Oncology, Arthritis and Immune Diseases - Technical Consultant #2054

Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...