Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Medicinal Chemist Consultant for API Process Research, Development and API Process Start-upSynthetic organic chemist and small scale chemical process research and development.Chemical process research and development for "small molecule" drug substances.Guidance for scale-up to provide material for Phases 1 - 3 and manufacturing.Pharmaceutical facility start-up troubleshooting.Assistance with CMC section of filings.Pharmaceutical laboratory process research leading to technology transfer and scale up.Design and implementation of practical, cost-saving, processes and procedures.Experienced with 12 hands-on manufacturing start-ups of drug su...

Bench-Scale Chemistry, Process Scale-Up, Pilot Plant Operations, Process Hazard Analysis, Toll processing, Technology Transfer, Fractional Distillation (Packed and Spinning Band Columns), Molecular DiSummary  Directing chemical research and process development in fast-paced manufacturing environments. Develop processes such as; Synthesis of silane and siloxane compounds for electronic applications (chemical vapor deposition) and silicone oligomers and polymers for diverse applications including coatings and personal care products. Focused Areas Synthetic organic chemistry. Analytical chemistry GC-FID, GCMS NMR, HPLC, AA, FTIR, U...

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...

Chemical Engineer for Chemical Plant Process Design and Economic Evaluation: Polybutylene Terephthalate and ButanediolSenior Consultant with ten years of research and design experience in the Process Economics Program of SRI Consulting.Experience includes 8 PEP Reports and becoming a winner of the 1996 Monsanto "Million Dollar Research Challenge" (Competition was International).Preceded experience of over 33 years of diversified research, development, and design work with Dow Chemical, a Fortune 20 company.During this time expertise was demonstrated in creative problem solving in basic and applied research, new product and process developm...

Mechanical Engineer Conducting diagnostics on existing systems and design. (IAQ), studies, forensics for ventilation design services for industrial, commercial, & residential buildings ConsultingForensic engineering for plant operations worldwide: Applying engineering principles to the investigation of failures or other performance problems in the commercial and residential property industries. Testing and evaluation of failure conditions to avoid real-world critical failure of plant operations. Design, manage, and installation of computer control systems for large-scale hotels and industrial applications. Civil engineering: Electric...

Engineering Consultant Expert in Kaolin Mineral Extraction and ProcessingIndustrial mineral facility layout, design and mineral facility operations.Mineral deposit development, extraction and process optimization.Kaolin mining and kaolin processing.Development of high performance teams.Mineral extraction in Brazil.Acquisition assessment.Independent Consultant, PresentProvides business and technical assistance primarily to industrial mineral companies.Expertise on improvements in current operations and process optimization.Identification and evaluation of potential acq...

Registered Civil Engineering Expert for Chemical Manufacturing Facilities with Specialized Knowledge in Piping Standards and DesignOver thirty-five years in process facility mechanical design and construction for the chemical industry.Work process redesign and implementation.Piping expert: Fabricated equipment design and specification, thermal fluid heat transfer system design, specification and standard writing, and work process redesign and implementation.Piping flexibility analysis, piping standards, and design tools development.Owner oversight of contractor front-end and detailed engineering.

Business & Academic Environments- Production & Operational Teams, Building B2B Industrial Companies in Plastics, Life Sciences Industries, and ISO 9001 AuditorSummary  Chief Technologist with the successful execution of production and operational teams in business and academic environments. Developed materials and products for B2B industrial companies, in plastics and life sciences industries. Deploying over 15 years of experience in processing plastics, chemicals, and downstream products including films and medical devices.  Author, composing and presenting, scientific papers, grant applications, Patent Inventor, and patent b...

Chemical Engineering Consultant for Refinery, Alternative Energy Studies, Research and Development, and Commercial GasificationMore than over 40 years of experience as a process engineer based on a long-term career with Exxon Research & Engineering Company.Process technical advisor for new and recommissioned hydrogen (H2) plant startups.Troubleshooting and resolution of H2 plant incidents.Independent ConsultantAssessed feedstock changes pertinent to the CoSyn Technology and H2 plant consulting for Syncrude H2 Plant...