Expert Details

Expert in Pharmaceutical and Fine Chemicals, Small and Large Scale Manufacturing

Expert ID: 735625 South Carolina, USA

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I earned my PhD at the Technical University (TU) of Karlsruhe, Germany in Organic Chemistry. I have knowledge and experience in the following realms: - Phospholipids - Pharmaceuticals (R&D, Manufacturing) - Vitamins.

Highly motivated, results oriented professional with over 35 years of pharmaceutical and fine chemicals industry experience. Exceptional knowledge in organic process chemistry. Very creative and innovative. Able to come up with “out of the box” ideas to improve existing and developing processes. Excellent technical support and problem solving skills. Diverse background with hands on experience in manufacturing, validation, technical support and quality.

Fluent in English and German.

Manufacturing ~ Validation ~ Technical Support ~ Process Optimization ~ Chemistry Issues


Education

Year Degree Subject Institution
Year: 1983 Degree: Ph.D. Subject: Organic Chemistry Institution: TECHNICAL UNIVERSITY OF KARLSRUHE
Year: 1984 Degree: Post doc. Subject: Institution: University of Rochester
Year: 1978 Degree: Masters Subject: Organic Chemistry Institution: TECHNICAL UNIVERSITY OF KARLSRUHE

Work History

Years Employer Title Department Responsibilities
Years: 2016 to Present Employer: Undisclosed Title: President Department: Responsibilities: • Owner & President of consulting business specializing in services to small and large scale manufacturing in the pharmaceutical and fine chemicals industry.
• Expertise in manufacturing, validation, technical audits and process optimization.
• Experience with starting materials, intermediates and API’s.
• Excellent problem solving abilities. Quickly understand new issues as they are presented and rapidly come up with potential solutions.
• Experienced in and familiar with all kinds of Membrane Processes (Reverse Osmosis (RO), Nano-Filtration (NF), Micro-Filtration (MF), Electro-Dialysis (ED), Gas Pervaporation and Pervaporation).
• Knowledgeable in and familiar with various types of Distillation Technologies (Wiped Thin Film Evaporator, Falling Film Evaporator, Short Path Distillation, Forced Circulation Evaporator, Continuous Distillation, Pressure Swing Distillation and Stripping).
• Experienced with several forms of Extraction Technologies (Centrifugal Extractors, Counter-Current Extraction (Using Different Column Types)).
• Very familiar with Process Scale-Up from lab to pilot plant and mini plant to large-scale manufacturing.
• Experienced in converting Batch Processes into Continuous and Quasi-Continuous Processes.
• Knowledgeable in Process Analytical Technologies.
• Experienced in the use of Fixed Bed Reactor Systems.
• Strong back-ground in Ion-Exchange Technologies.
• Experienced in Acquisition and Analysis of Thermal Hazard and other Chemical Safety Data.
• Capable of developing Mass-Balances and Manufacturing Cost Calculations for chemical processes and experienced in General Budgeting.
• Knowledgeable in requirements for testing and handling of Chemical Waste Streams.
• Experienced in solvent recovery operations.
• Experience in performing cost calculations for the production of intermediates and API’s. Used these calculations to assess potential cost saving opportunities.
Years: 2010 to 2015 Employer: Title: Scientific Fellow, Senior Chemistry and Process Optimization Expert Department: Responsibilities: • Advisor and consultant of the Manufacturing, Science, and Technology (MSAT) group.
• Providing chemistry support, guidance, and advice to the members of the MSAT group and to its customers.
Years: 2009 to 2010 Employer: Ideation, Innovation Implementation Title: Manager Department: Process Optimization of I3 Team Responsibilities: • Managed the Process Optimization Team to ensure a high level of technical expertise was provided in support of the manufacture of Active Pharmaceutical Ingredients (APIs).
• Established a team with a strong sense of urgency, innovative ideas to prevent and resolve chemistry issues.
• Interacted and exchange information and expertise with the global MSAT group.
• Responsible for all production recipes and MBR generation in Manufacturing.
• Responsible for all process fits for new products in regarding of chemistry.
Years: 2000 to 2009 Employer: Process Optimization Lab Title: Manager Department: Responsibilities: • Managed the Process Optimization Laboratory (POL) which was tasked with supporting chemical manufacturing. This support included trouble-shooting from both an analytical and process perspective as well as improving existing Manufacturing processes through reductions in cycle times, yield increases, and both quality and financial improvements.
• This lab was also responsible for developing and optimizing new processes coming into Manufacturing and also for participating in the transfer of processes both coming in and going out of the facility including small scale production laboratory, In Process Control (IPC) Laboratories, and Environmental Testing Laboratories.
Years: 1989 to 2000 Employer: Hoffman-La Roche Title: Manager Department: Chemical Technical Lab / Process Development and Support Responsibilities: • Managed a department of ~30 employees that was responsible for a variety of tasks, including process development and optimization for the synthesis of a variety of vitamins and their intermediates, trouble-shooting existing processes, and providing analytical investigations.
• Performing tasks involved effectively coordinating laboratory, mini-plant, and pilot plant groups to develop and transfer these processes into Manufacturing
Years: 1985 to 1989 Employer: Lipoid KG Title: Manager R&D Department: Responsibilities: • Head of the research and developing department that was responsible of the syntheses for a variety of phospholipids (lecithines) and also for performing small-scale manufacturing. Besides developing the syntheses, these tasks included modification via hydrogenation, enzymatic conversions, and purification of lecithines from various natural sources, and the analysis of the products and intermediates..
Years: 1984 to 1985 Employer: Institute of Organic Chemistry of TH Karlsruhe Title: Scientist Department: Responsibilities: • Under a grant from DFG (Deutsche Forschungs Gesellschaft), performed original research on heterocyclic chemistry. Continued a line of research during my doctoral studies.

Career Accomplishments

Publications and Patents Summary
Publications: 6

Fields of Expertise

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