Ph.D. Oncologist with Expertise in Cloning Studies and Flow Cytomertry Panel Design and Immuno-Oncology Study Design in Humanized MiceImmuno-oncologist in various immunological and flowcytometric assays designs for humans and mice.Flowcytometry: Designing and running panels (both intracellular and surface) using various machines on 4-10 color platforms (BD FACS Aria, Calibur, LSR II, Canto, MoFlo) on human PBMCs, AML samples from patients and mouse cells ex vivo and in preclinical humanized models of mice on NOG platform.Creating and studying in vivo mouse models to analyze T and myeloid cells from humans and mice (RAG/BALB/C57Bl6) for in...

Designing, Commissioning, Qualification and Validation in the Pharmaceutical IndustryPharmaceutical standards regulations: BPF, BPL, GMP, Europ%uFFFFe Pharmacop%uFFFF and FDA 21CFR part.11.Quality assurance and the standards regulations requirements for the pharmaceutical industry.MethodologyRisk Analysis (AMDEC, HACCP)Six SigmaTechnical ExecutionPharmaceutical quality assurance and the standards regulations requirements.Design, quality, commissioning and qualification documentation of pharmaceutical processes.FAT, (Factory Acceptance Testing),SAT, (Site Acceptance Testing) commissioning, (re)qualification and validation tests.Aseptic pro...

Estuarine and Marine Ecosystems Assessments, Studies, Determining Aquatic Ecosystems and Marine And Atmospheric ConsultingExtensive wet lab, dry lab, and field work experience including:  Environmental ecosystem assessments in the computing languages R and Matlab. Application of multivariate, univariate, and spatial statistics to environmental datasets. Image analyses in ImageJ. Application of high-performance liquid chromatography (HPLC) and microscopic approaches for environmental samples. Analysis and interpretation of next-generation sequencing data and molecular samples for microbial community assessments. Culturing and i...

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...

Strategic Chemical and Specialty Chemicals Technology Management: New Drug Applications and DevelopmentGuiding clients through complex chemical technology development programs.Identifying new technology enabling business opportunities, process improvements, debottlenecking opportunities, and planning capital upgrades to increase productivity of specialty chemical plants.Defining the content of the(CMC) Chemistry Manufacturing Controls component of new drug applications (NDA) and developing the strategy for completion of necessary work in individual technology areas.Leading the effort to develop a guiding vision and organizational structur...

Pharmaceutical Microbiology Quality and Regulatory Consultant with Expertise in Process Validation, Steam Sterilization, PDA's, ASQ Certified.Regulatory affairs and quality assurance certified with ASQ.Over Twenty-five year's expertise in sterile process validation, steam sterilization and aseptic processing.Pharmaceutical microbiology, and chaired PDA's Microbiology and Environmental Monitoring Interest Group for over fifteen years.GMPs, data integrity, sterile process validation, steam sterilization, microbiology, environmental monitoring, regulatory updates, and conducting regulatory submissions.Expert Witness ExperienceInternational pa...

Large Molecule Bioanalytical Consultant with PK, PD, and ADA experience. Over 20 Years Experience Developing and Validating Bioanalytical Methods to Support Drug Development Programs.  Experience in Summary  Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist.  Expert in Ligand Binding Assays including immunogenicity. Successfully implemented complex acid...

Ph.D. Biochemistry Food and Nutrition Expert. Food Emulsion Biochemistry and Physical Chemistry, Fermentation and Coagulation within Non-Dairy SystemsNutritional food and beverage product development, bridging between chefs, food technologists, protein chemists and biochemists, and executives.Industry research planning, methods development, rapid prototyping, product development management and troubleshooting, patent applications, product upscaling, co-packer and business-to-business relations, and brand ambassadorship to both businesses and consumers.Product-specific reduction and elimination of eggs and dairy ingredients in a variety o...

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Medicinal chemist and Pharmaceutical Technology Consultant with Expertise in Drug Research, Drug Formulation, Drug Analysis, Drug Synthesis and Purification, In-Vitro, In-Vivo (Efficacy and Pharmacokinetics) and Dosing RoutsDiscovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formul...