Phosphates, Phosphoric Acid, and Alkali Process Development ConsultantChemical and process development.Analytical method development.Membrane filtration and separation.Carbon treatment and absorption.Solvent extraction of phosphoric acid.Electrochemical cell operation.Crystallization processes for carbonates, phosphates and peroxides.Ion exchange processes to remove heavy metals.Processing of phosphate salts including dipotassium phosphate (DKP).Statistical process control.Experimental design.Undisclosed Company, Senior Chemist and Laboratory Manager, 2007 - PresentGlass...

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...

Ph.D. Organic Chemist Pigment Specializing in High Performance Pigments Process Development Including Quinacridones, Isoindolinones, Condensation Azos, Quinacridones, and PerylenesHigh performance and conventional organic pigment research and development.Process and product Improvement.Plant design and start-up.Fine particle technology.Surface treatments.Literature searches.Independent Consultant, PresentOrganic pigments development for various clients in the pai...

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...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

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...