Pharmaceutical chemist experineced in regulations and good manufacturing procedures.Drawing on expertise in the areas of:FDA regulationsNew Product DevelopmentMarketing Research and MarketingFinancial Aspects of Product DevelopmentFormed my own business. Served clients in the areas listed. Interfaced with FDA on such issues as: establishing Drug Master File (DMF), chemicals extracting from package into medicinal preparation, validation procedures, etc. Prepared and delivered training seminars on Effective Communications, Negotiating Techniques, Business Aspects of the Technical Function, Strategic Planning, and delivered seminars for other...

Photopolymer consultant specializing in optoelectronic technology, digital printing and imaging and new business development for optoelectronic devices and materials.Photopolymer consultant for for optical communications and digital printing and imaging.Acquisition strategy and indepth due diligence experience for acquisition of optical materials and optical device new businesses and technology.Consultant for flexographic printing, printing plates, photo resists and overall imaging technology.Expert witness on technology issues related to optoelectronics, photopolymers, lasers and related business arrangements.

Molecular biophysics with expetise in development of novel biomimetic ligands.Biomimetic ligand design and characterization, biomolecular recognition.Expert and consultant in molecular biophysics.Skilled in surface chemistry, colloid chemistry and nanoscale particle synthesis.Polymer physical chemistry and synthesis of collodial systems.Molecular, nanoscale to microscale applications.Drug development process (NDA%u2019s. IND%u2019s).Applied analytical methods %u2013 Nuclear Magnetic Resonance, High Pressure Liquid Chemistry, Mass Spectrometry.Scientific Translation: Fluent in German, Swedish and English.

Protein and peptide identification, mapping, purification and analysis expert.Identification of post-translational protein modifications (phosphoproteins)Peptide mapping and protein ID by LC/MS/MSEnzymologyAnalytical ultracentrifugationMass spec analysis of proteins, peptides, organic molecules by LC/MSAutomated protein purification and electrophoresisCalorimetryHPLCImmunological TechniquesMerck & Co., West Point, PA 1986-2005Senior Research Fellow (1994-2005)Evaluated new protein analytical platforms and performed protein analysis for all proteins submitted f...

Microbiologist expert in agricultural immunoassay and analytical method development and biosecurity, especially antigens, antibodies, animal hematology, off-flavors in food, mycotoxins, fatty acidsAgricultural chemistry, specializing in immunoassay and analytical methods development, including ELISA, Western Blot, Monoclonals.Separation chemistry using LC, HPLC, GC, GC/MS.Familar with "Electronic nose%" SAW portable GC.Experience in antigen and antibody purification.Animal hematology such as Ig, Complement, Lysozyme.Off-flavors in food using GC/MS, other instruments and trained dogs.Mycotoxins detection in grains and forage including ergot...

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...

Protein Chemistry Consultant Specializing in Protein Purification, Characterization, Analysis, Research and Protein DevelopmentDeveloped novel procedures for purification of proteins from recombinant sources including: bacteria, yeast, mammalian cells and viral expression systems.Purified recombinant proteins containing affinity tags such as six-histidine and glutathione transferase; published new procedure for purification of c-myc tagged proteins by immuno-affinity chromatography.Large-scale production of native proteins from animal tissue and blood products.Developed two commercial products for clinical diagnostics market.Isolated and...

Microbiologist Consultant for Microbial Cell Culture and Fermentation, Process and Equipment Validation ExpertOver thirty years of research, development, QA/QC, technical service, validation, manufacturing and engineering management experience in the food, pharmaceutical and biotech industries.Design, construction, scale-up, start-up, validation and operation of biotechnology and pharmaceutical manufacturing equipment and processes.Validation activities for pharmaceutical processes, for example, in an aseptic fill and finish facility for ophthalmic and parenteral solutions.Microbial physiology, biochemistry and genetic mechanisms controll...

Consultant for Biopharmaceutical Process Development, Operations and cGMP CertificationOver thirteen years in the life science industry with more than ten years of downstream process development, technology transfer and cGMP experience for combined biopharmaceutical, in vitro diagnostics and medical device industry.In depth experience in finding and implementing practical solutions to both midstream and downstream processes.Four years of hands on experience working in the clean room environment, witnessing and troubleshooting the processes, data analysis and quality oversight within a highly regulated cGMP manufacturing environment.Four ye...

Ph. D. Protein Drug Products Expert including Enzymes, Antibodies and Antigens and the Purification and characterization of proteins and glycoproteins.Purification and characterization of proteins and glycoproteins.Protein and glycoprotein drug products including enzymes, antibodies and antigens.Enzymology - development of reliable, linear assays (colorimetric, fluorometric, radioactive), kinetic analysis of enzymatic reactions.Technical writing and editing (e.g., CMC sections of new drug applications, biological licensing agreements; technical reports, white papers, development reports, validation reports).Miscellaneous separation techniq...