Expert Details

Expert in Biotechnological Pharmaceutical Chemical Process Development Design Engineering

Expert ID: 722788 California, USA

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Expert has applied his extensive background in chemical engineering in various areas including pharmaceutical process and product development; developing new products for pharmaceutical and consumer industries; process, equipment, and analytical method validation in biotechnology areas; and designing and improving various novel oily wastewater and hazardous waste treatment options. He is very well-versed in all theoretical (process modeling and mathematical modeling) and practical aspects of chemical engineering including but not limited to areas such as biotech process unit operations including Upstream, Downstream, and Fill-Finish operations, polymer processing, composites, the heavy chemical industry, pharmaceutical and biotechnological industries, wastewater treatment, and in other related areas. He has three patents in the areas of pharmaceutical process and product development.

He has applied concepts of chemical engineering to various separation methods in biotechnological separation methods. Specifically, he has designed, scale up, and operated large sacle Process Chromatography skids based on Affinity adn Ion Exchange chromatography chemistry. Additionally, he has developed and validated processes for various chromatographic separations including size exclusion, affinity, anion exchange, HPLC, and protein A chromatography. He has performed hands-on packing studies and has performed data analyses including residence time distribution (RTD) studies. He has evaluated chromatographic characteristics such as HETP, number of plates, symmetry, tailing, etc. He is well versed in analytical and process chromatography. Additionally, he has thorough knowledge of other separation methods such as distillation (azeotropic, binary, multicomponent, and flash), liquid extraction, filtration, and absorption/stripping.

He has developed novel pharmaceutical formulation for 3 products (3 patents): A Hydrogen peroxide dental bleaching gel, a eutectic based soldi dosage form to improve dissolution of sparingly soluble actives,and a fiber-based nutraceutical dosage form.

He has trouble shooted validated and commisioned large scale Freeze Dryers (Lyox 2 to 56) and is thoroughly familiar with Process adn Cycle development for Lyophilization, optimization of Freezing Primary Drying steps, Stoppering. Has conducted technical training sessions on Lyophilization. He has developed and modified Lyophilization cycles of various protein & biomolecules using various Lab equipment including Freeze-Dryer Microscope, DSC, Pilot Lyophilizers, BET surface area measurement equipment, TDLAS, Controlled nucleation technology

Expert has applied concepts of chemical engineering to evaluating and developing new drug delivery methods. He has studied various drug delivery methods using reservoir systems, matrix systems, osmotic systems, hydrogel systems, and erosion systems. He has developed a new matrix-type ocular delivery system for a glaucoma drug. He has operated pilot systems to manufacture drug containing polymer films by extrusion, calendering, and mixing. He has performed extensive data analyses of drug delivery systems to calculate drug deliver rates. He is thoroughly familiar with novel drug delivery systems such as liposomes, transdermals, and powders. He is very familiar with various polymeric materials and excipients used in drug delivery systems.

Expert has applied concepts of mass transfer in various areas. He has used diffusional mass transfer concepts to design zero-order drug delivery systems having features of reservoir systems. He has used mass transfer concepts to evaluate transdermal systems and osmotic systems. He has used mass transfer concepts to study and evaluate separation systems such as chromatography, reverse osmosis and ultrafiltration, freeze drying, and other related process areas.

Expert has extensive hands-on experience with various clean-in-place cycles and skids used for cleaning various biotechnological and other process equipment. He has developed various CIP cycles having pre-rinse, caustic wash, acid wash, post-rinse. and air blow phases. He is very familiar with PLC programming of CIP cycles. He is extensive familiar with troubleshooting CIP cycles for removal of dead-legs, adequate washing, choosing proper detergents for a product etc. He is extensively familiar with various acceptance criteria namely TOC, conductivity, pH, endotoxin, etc. used to validate CIP cycles. He is very familiar with swab and rinse procedures used to evaluate a CIP cycle.

He has worked extensively with various industrial freeze dryers (BOC/Edwards, Stokes, and Leybold). He has performed commissioning (SAT testing), IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) of various industrial freeze dryers. He has written, executed, and troubleshot IQ/OQ/PQ protocols in the biotechnological industry. He is thoroughly familiar with all the phases of an industrial freeze-drying cycle including freezing, primary drying, secondary drying, and stoppering. He has developed steam sterilization procedures for industrial freeze drying systems. He is thoroughly familiar with engineering and process/formulation related issues of a freeze-drying system. He has helped develop optimized freeze drying cycles for various products and are very familiar with various excipients used in various products. He is also very familiar with the vacuum systems and refrigeration systems, which are parts of an industrial freeze-drying system. He has trained technical personnel in freeze drying operations.

He has extensive hands-on experience with various industrial lyophilization operations including protein lyophilization. He is thoroughly familiar with various cryoprotectants, e.g. sucrose, mannitol, and trehalose used to formulate protein formulations meant for freeze-drying. He is very familiar with stability issues of freeze-dried protein formulations such as agglomeration, deamidation, and chain unfolding. He has participated in cycle development and scale-up of protein formulations optimized for freeze-drying. He is very familiar with optimizing freezing, primary drying, and secondary drying phases of a freeze-drying process.

He has extensive hands-on experience with industrial Refrigeration systems used for providing refrigeration to freeze dryers, and various freezers. He is very familiar with various critical components of an industrial refrigeration system including compressors, suction accumulators, oil separators, condensers, expansion valves, piping, various temperature and pressure switches, etc. He has troubleshot refrigeration skids for refrigerant leaks, chilling water problems, and other technical issues. Expert has extensive hands-on experience with industrial vacuum systems used to provide deep vacuum in freeze-drying and other systems. He is very familiar with Roots blowers, oil-sealed vacuum pumps, various valves, gages (MKS, Pirani, and RGA) used in vacuum systems. He has troubleshot vacuum systems for various technical problems including leaks, back-streaming, controls etc. He is very familiar with various flow regimes in vacuum systems including volume gas, surface gas, viscous flow, and molecular flow.

Developed a novel hydrogen peroxide dental bleaching gel and its application procedure from bench scale to manufacturing for a U.S. company with Japanese affiliations (patent granted). He developed the formulation, manufacturing process, laboratory testing procedure, etc.He is currently consulting for various biotech companies for process and product development, analytical methods, and equipment validation projects.

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1989 Degree: Ph.D. Subject: Chemical Engineering Institution: Clemson University, USA
Year: 1984 Degree: M.Sc. Subject: Chemical Engineering Institution: The University of Calgary, Canada
Year: 1980 Degree: B.S. Subject: Chemical Engineering Institution: Jadavpur University, India

Work History

Years Employer Title Department Responsibilities
Years: 2001 to Present Employer: Undisclosed Title: Director of Technical Services Department: (Undisclosed) Responsibilities: Expert is responsible for designing and starting up large scale process chromatography skids, commissioning, cycle development and troubleshooting Large scale Freeze Dryers, validating various biotechnological processes including sterilization, thermal mapping of process vessels, IQ/OQ/PQ of various processes including freeze drying, CIP, pasteurizer, and bioanalytical method development. He is responsible for writing protocols, executing protocols, data analyses, and final package preparation. He is also responsible for troubleshooting and development of various processes including chromatography column packing, operation, CIP skids, and DCS routines.
Years: 1998 to 2001 Employer: (Undisclosed) Title: Senior Scinetist Department: Somerset, NJ Responsibilities: He was responsible for developing various dosage forms including gels (lidocaine), suspensions, parenterals, and controlled delivery products (matrix type to deliver ocular drugs). He was responsible for designing experiments, executing experiments, writing reports, setting up an R&D lab, managing lab personnel, scale-up, and technology transfer. He prepared CMS docs for ANDA and NDA submission.
Years: 1997 to 1999 Employer: (Undisclosed) Title: Research Engineer Department: CHANTILLY, VA Responsibilities: Expert researched new processes for developing drug microparticles to improve solubility, microfluidizers, and rotational atomizers. He developed and patented a eutectic drug formulation. He managed a product development lab for nutraceutical products such as multivitamin soft chews, bars, and tablets.
Years: 1995 to 1997 Employer: (Undisclosed) Title: Process Development & Research Engineer Department: Alexandria, VA Responsibilities: He developed pilot scale and full-scale wastewater treatment systems for removing heavy metals using chelate binding chemistry (using polyethyleneimines and pH control) and polymer ultrafiltration. He specced out pumps, tanks, ultrafiltration membrane modules, and control systems. He troubleshot chelate binding, ultrafiltration, and diafiltration (to regenerate polymer). He built skids, conducted pilot studies in electroplating facilities, wrote reports, and gave presentations. He supervised chemists, chemical engineers, and technicians. He also developed automation.
Years: 1993 to 1995 Employer: (Undisclosed) Title: Process and Environmental Engineer Department: Baltimore, MD Responsibilities: Expert developed novel oily wastewater treatment systems using cement plant wastes (fly ash); this was a DoE SBIR project). He performed bench scale systems to evaluate flocculating efficiencies of various types of fly ash, designed a pilot systems consisting of oily wastewater separator, DAF (dissolved air flotation), flocculators, and clarifiers. He performed pilot studies in POTW sites in Maryland. He wrote reports, and performed calculations and analyses. He troubleshot a sulfamic acid-based nickel electroforming bath for nickel electroplating of a ceramic mold for fast prototyping.
Years: 1990 to 1993 Employer: (Undisclosed) Title: Process and Environmental Engineer Department: Signal Hill, CA Responsibilities: He troubleshot a used oil re-refining facility using a flash distillation process; he troubleshot oil-fired heaters, heat exchangers, distillation columns, and process vessels. He developed membrane systems for antifreeze recycling, and absorbers for treating acid gases. He operated and designed various units of an industrial wastewater treatment system consisting of oil separators, DAFs, polymer/alum-based flocculators, clarifiers, sand filters, and activated carbon filters. He wrote environmental permits for the facility and interacted with the SCAQMD (Southern California Air Quality Management District). He wrote reports and performed process calculations. He supervised engineers and technicians.
Years: 1989 to 1990 Employer: (Undisclosed) Title: Technical Director Department: Summerville, SC Responsibilities: Expert set up a polymer characterization (physical and chemical) laboratory for testing incoming resins including polyester (PET), nylons (nylon 6, 66), and polyurethanes. He conducted various tests and a troubleshot monofilament extrusion process. He evaluated finished monofilaments using various physicochemical tests. He performed mechanical testing of monofilaments using Instron testing machines. He supervised chemists and technicians.
Years: 1986 to 1989 Employer: (Undisclosed) Title: Research Associate and Ph.D. Student Department: Clemson, SC Responsibilities: He designed various bench scale procedures to prepare carbon fiber-epoxy composites (unidirectional filaments) using a resin impregnator and compression molding. He evaluated composites for interfacial bond strength using various destructive and non-destructive tests using double cantilever beam method (DCB), tensile testing, crack propagation, microscopic testing, SEM, and dynamic mechanical analysis (non-destructive). He wrote his Ph.D. thesis and a paper based on these findings and published in the Journal of Composite Materials.

Career Accomplishments

Associations / Societies
Expert is a member of AIChE and IIChE.
Licenses / Certifications
He is a registered P.E. in Chemical Engineering.
Awards / Recognition
Expert was awarded the National Merit Scholarship during his undergraduate studies.
Publications and Patents Summary
He has three patents in the areas of pharmaceutical formulation and processing. He has two publications in technical journals.

Additional Experience

Training / Seminars
He delivered various technical seminars to company personnel on the topics of design and development of large scale Biotech Purification Process trains including Chromatograhy, Tangential Flow Filtration, Dead End Filtration, In-line dilution. statistics, fundamentals of freeze-drying, bioanalytical methods, and column packing studies.
Vendor Selection
He has sources of various process equipment including pumps, piping, ultrafiltration membranes, RO membranes, tanks, valves, chemicals, and lab equipment.
Other Relevant Experience
He has managed R&D and engineering projects of various sizes. Has 3 patents for developing various Pharmaceutical formaulations.

Has fluency in 3 languages: English, Hindi, and . Bengali. Has varied degrees of proficiency in German and French.

Language Skills

Language Proficiency
German Reasonably proficient in speaking, reading, and writing German.
French He is reasonably proficient in speaking, reading, and writing French.
Hindi Fluent in Hindi.
Bengali Fluent in Bengali.

Fields of Expertise

biotechnology process engineering, chemical engineering, chemical separation, drug delivery, mass transfer, clean-in-place, freeze drying, protein lyophilization, refrigerant piping, vacuum technology, pharmaceutical process engineering, chemical plant operation, chemical plant start-up, chemical process design, chromatography, purification, skid, oil separator, melt extrusion tableting process, chemical industry, industrial biotechnology, ampule, titration, Karl Fischer technique, drug release polymer, food biotechnology, hot plate, food product development, analytical testing, Generally Recognized As Safe, drug degradation, analytical chemistry instrument, carbon film, analyte, chemical indicator, skin permeability coefficient, freezer, polymer drug-delivery method, polymer drug-delivery microsphere, cream, chemical plant management, parenteral drug delivery, chemical manufacturing facility evaluation, transmittance, chemical plant layout, controlled-release drug delivery technology, food processing technology, chemical plant, food heat transfer, chemical analysis separation, drug dosage form development, chemical precipitation process, distillation, quantitative chemical analysis, qualitative chemical analysis, chemical plant design, solvent extraction, food engineering, controlled-release drug delivery, food extrusion screw, food formulation, chemical process, analysis technique, process chemistry, on-line process analysis, ocular drug delivery, dosage form, analytical chemistry distillation, chemical analysis, calorimetry, atmospheric distillation, analytical chemistry

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