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...

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...

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...

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...

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...

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...

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...

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...

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...

Pharmaceutical Srategic Product and Portfolio Management Consultant for Generic Pharmaceuticals and Biosimilar drugs for Domestic and International Marketing. IP, Regulatory, and icensingGeneric pharmaceutical strategic product and portfolio management for generic pharmaceuticals.Biosimilar drug development, intellectual property, regulatory and licensing.Generic commercial issues and legal strategies for developing generic medicines.Commercial aspects of generic industry with extensive international experience at senior level.European marketing and business development in the generic pharmaceutical industry.Consultant to non-European com...