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...

Ph.D. Expert Developing Immunology and Molecular Assays, Due Diligence, Gene Editing, RNAi, Automated Cloning, CRO, CMO and IND SubmissionsAssessments and due diligence for funding of synthetic biology companies. Mentor to start-ups within the Biological portfolio to attain seed and series funding.Synthetic biology, specialty chemicals, and nutraceutical products.Develop and execute cell-based, immuno, and molecular assays for release of large molecule therapeutics.Development of assays for large molecule therapeutics from multiple modalities including monoclonal antibodies, antibody-drug conjugates (ADC), T-cell engagers, and small pept...

Ph.D. with expertise in Drug Metabolism and Pharmacokinetics, Pharmacodynamics, and Toxicokinetics. Investigational New Drug approval experience in USA and ChinaDMPK (Drug Metabolism and Pharmacokinetics), PD (Pharmacodynamics), TK (Toxicokinetics), Toxicology, and Safety fields.Oversight of outsourced GLP studies and in-house non-GLP studies for candidate drugs in oncology, inflammation, anti-virus, and hypertension fields.IND (Investigational New Drug) approval both in U.S.A. and China, as well as 15 years of experience in small molecular novel drug discovery and development, and 20 years of experience in drug metabolizing genes/enzymes...

Food processing expert including extraction, concentration, extrusion, drying, ultrafiltration, nanofiltration, reverse osmosis, industrial waste recovery, rheological and transport characterization Modeling, simulation and control of chemical and food industry processes. Renewable energy: Energy from biomasses. Membrane Science and Technology Biotechnology and biotechnological processes; Food industry unit operations: Extraction, concentration, extrusion and drying. Acoustics.

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...

Fermentation design and optimization, solid state fermentation, purification operations and production of small and large molecules by biochemical routes.Design of fermenters, fermentation optimization and solid state fermentation.Pilot plant fermenters.Bubble column fermenters.Spray drying of bioproducts; ultra filtration of bioproducts.Fermentation contamination abatement.Solvent extraction of fermentation products and biproducts.Experience with: Enzyme production, organic acid production, amino acid production, omega 3 fatty acid production, yeast fermentation and starch conversion technology.AccomplishmentsDesigned products and fermen...

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...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

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...

Multi-Disciplined Expert Working in the Health, Energy, Environment, Advanced Material-Coatings Industries covering areas in: Biomaterials and Bone Tissue Engineering, Drug Delivery, BiodegradablesSummary Materials Science, Technology and Manufacturing Engineer in Research and Development, (R&D) providing over 27 years of experience working in the industry and academia, Included in Stanford University’s List of World’s Top 2% of Scientists, USA Metallurgy engineering, coatings and corrosion consultancy: Providing graduate level  educational in the STEM area, maintaining a high standard of quality and connecting R&D....