Sarah — fermentation subject matter expert

2016-Present DSM Nutritional Products, Belvidere, New Jersey Contract Engineering - Responsible of engineering package for fermentative biotechnological method of increased production of Vitamins. - Adept in Upstream processing including Sterilization of the equipment, CIP, preparation of medium, Calibration, Inoculum preparation and fermentation including biomass and product formation. - Responsible of Downstream processing constituted product extraction, purification&assay, waste treatment and by product recovery. Scaled up and commercialized the production of primary metabolites of microorganisms. - Utilized the Lyophilizer to enhance the stability of the protein pharmaceutical and allow it to be stored for longer periods for the next batch. - Provides SAP support for the quality management team and identify the number of times of a defect status and generate material defects reports. - Responsible of Monitoring and analyzing bioreactor-operating parameters such as physical parameters including time, temperature, pressure, agitation Speed, total mass, total volume, volume feed rate, viscosity of culture, power input, foam, shear, mixing time, circulation time, gas holdup, bubble size distribution, impeller flooding, broth rheology, gas mixing patterns, liquid level, reactor weight, foam level and chemical parameters such as pH, Redox potential, Dissolved oxygen, dissolved carbon dioxide, O2 in gas phase, CO2 in gas phase, lipid, Carbohydrates, enzyme activities, nitrogen, ammonia, mineral ions, precursors, inducers, growth stimulants, products, volatile products, conductivity, off gas composition and biological and cell properties such as respiratory quotient, O2 uptake rate, CO2 production Rate, Optical density, Cell Concentration, viability of cells, Cell morphology, cellular composition, protein, DNA, RNA, ATP/ADP/AMP, NAD+/NADH, activities o whole cells, specific growth rate, specific oxygen uptake rate, specific substrate uptake rate, metabolites, growth factors, growth inhibitors, biomass composition, biomass concentration to increase the fermentative biotechnological method of Vitamin production. - Supported Emerson Delta V system and troubleshooted instrument malfunction. - Delivered construction and start up services including valve sequence for startup from water batching, lower risk production to full-scale production in terms of phased completion. - Served as fermentation subject matter expert on site and Successfully Solved foaming related challenges constitute reduction in the working volume of the fermenter due to oxygen- exhausted gas bubbles circulating in the system, changes in bubble size, lower mass and heat transfer rates, invalid process data due to interference at sensing electrodes and incorrect monitoring and control and provide adequate provision for temperature control when design the inoculation vessel body by considering the Heat produced by microbial activity and mechanical agitation. - Troubleshot Process Equipment and Incident Investigation and Initiated Process Flow Diagrams (P.F.D.), Piping Instrumentation Diagram (P&ID) and defined control strategy. Successful in plant commissioning, HAZOPs and PHAs for multiple processes. - Responsible of Sterilization the fermenter by heating the coils of the fermenter with steam and sparging steam into the vessel through all entries, aparting from the air outlet from which steam is allowed to exit slowly. Held Steam pressure at 15 psi in the vessel for 20 minutes and sparged the sterile air into the fermenter after the cycle is completed and maintain a positive pressure to avoid vacuum and unsterile air drawn into the vessel and provided 3 approaches to solve foaming issues and minimizing the usage of antifoam such as by using a defined medium and a modification of some of the physical parameters such as pH, temperature, aeration and agitation, assuming that the foam is due to a component in the medium and not a metabolite or by implementing the mechanical foam breaker to minimize the impact on oxygen transfer rate. - Successfully Optimized inoculation development for industrial fermentation to maintain a healthy, active state thus minimized the length of the lag phase of Blaskeslea trispora to manufacture natural?-Carotene and Increased the dissolved oxygen concentration in the medium by increasing the air flow rate and the rpm of the impeller. - Led the Reduction of the contamination rate and increased the production by 4367 MT/yr and created $7M profit by disassembling all fermenter valves after an infected run and eliminating the use of threaded nipples or valves on a fermenter because the threads are a site of potential infection. - Developed operation protocols for CIP System and Provided commissioning to support design development process by performing multiple, detailed and rigorous design document and specification reviews and Oversaw and participated in the development of comprehensive and approachable commissioning reports to describe in-field findings and testing results. - Supervised the cleaning of centrifugal pumps and piping immediately after the transfer of Inoculum from seed fermenters and sterile feeds to the fermenter has been completed by air pressure. - Successfully Provided required cooling to cool media from sterilizing temperatures, to remove the exothermic heat of fermentation, to cool broth before harvesting, and to cool the compressed air and reclaimed some portion of the heat to produce hot water for the preparation of new substrate, and for general cleaning of equipment, platforms and floors. - Ensured that filters on the mass spectrometer don't plug and result in excessive back pressure. Saving potential $3M dollars cost. - Successfully Created $3M value per year by increasing fermenting time and Shortening the turn around time including emptying, cleaning, filling, batch sterilizing and cooling by utilizing continuous sterilization methodology, etc. - Managed all aspects of Statistical analysis and optimization of the usage of yeast extract to provide a range of B vitamins and substrate that would be too expensive to supply in the pure form on a routine basis to produce Arachidonic Acid for PUFA. - Successfully Eliminated contamination batches from 50% to 0% by analyzing the sources of contamination including contamination of the plant stock culture due to poor techniques, Contamination by the raw materials used in the fermentation, Contamination attributed to inadequate sterilization of the equipment, air or media involved in a fermentation plant, Contamination attributed to inadequate procedures, or procedures not being followed, or insufficient operator training, Contamination caused by lack of a definite routine maintenance schedule on all the fermentation equipment, Contamination by bacteriophage and construction materials, seals and valves, complexity of the plant, operator error, instrumentation failure, process air, transfer and feed lines, contamination from vegetative pre culture, critical medium composition and inadequate procedures. Slashed $5M operation cost. - Successfully Served as the customer and Vendor interface for the department on projects and Incorporated RFP, RFQ, IQ/OQ document and Completed project updates and reports working to achieve total project success

2016 Prinston Pharmaceutical, Cranbury, NJ Contract Engineering - Supervised implementation, commissioning, and validation of clean room spaces and process equipment. - Responsible of Production operations associated with the manufacture of all cGMP products. Developed weekly/monthly goals and schedules to manage activities. Responsible of cGMP and FDA-compliant record keeping - Responsible of Process development and scale-up and Responsible of Pharmaceuticals testing and associated equipment - Design of Experiments (DOE) and Bid Analysis. Acted as a liaison on technical issues with related companies. - Responsible of Pharmaceuticals production and associated equipment. - Responsible of Equipment Qualification and Validation IQ/OQ/PQ, SOPs. - Led new facility renovation project, conduct Needs assessment, Front-end planning, Preliminary design, Construction document development, Procurement, Construction, Start-up and validation. - Analyze the contamination risks of injectables which are heat-sensitive and cannot be terminally sterilized and to prevent contamination of the product during transport to and loading of the lyophilizer, contamination of the product during the lyophlization cycle, cross-contamination between containers in the lyophilizer, product loss and difficult cleanup due to entrained powder and worker exposure to toxic compounds being lyophilized - Developed Project Management plan, Gantt chart, Project schedule and WBS, etc. Set Goals and Led kick off meeting and status meetings. Developed Plans for Scope Management, Time Management, Cost Management, Human Resource management, Risk Management, Quality Management, Procurement Management and Stakeholder Management. Familiar with CFR 210&211. Supervised execution of contracts and delivery of purchased items. Prepared RFQ and RFP. - Facilitated Irbesartan solid dosage Scale up from lab to pilot plant to FDA-compliant production-scale. - Delivered user requirement specifications for high shear granulator and fluid bed dryer, etc. Saved $1M initial cost and $10M operation costs. - Performed common Excipients selection including binders, fillers(diluents), disintegrates, lubricants, glints, and anti adherents. Developed PFDs for Wet granulation, Dry granulation, Direct compression, Extrusion, Film coating process,etc. Responsible to Develop film coating process and Analyze surface effects in film coating. - Responsible toTreat the exhausted gas from film coating processes. - Facilitated film coating automation and evaluated and compared coating automation systems such as Data acquisition system, Distributed control system and Centralized control system. - Validated Solid Dosage Forms including validation of raw materials, analytical method validation, Equipment/Facility Validation, Define and control process variables, Validate Tablet Composition, Process Evaluation and Selection and Equipment Evaluation. SAT/FAT ( testing) & commissioning of control systems. - Managed all aspects of the work of Sharing documentation, batch records, SOPs, logbooks, etc with the pilot plant and manufacture facility and responsible for process technology training, equipment SOP writing and Validations. - Managed all aspects of the work of product development and comparison of wet granulation-aqueous/non-aqueous, dry granulation-slugging/roller compaction, and direct compression and comparison of open cycle and closed cycle spray drying system, and selected particle growth methods according to particle size range, etc. - Calculated fluid bed spray rate and analyzed significant process variables such as inlet air temperature, humidity, fluidizing airflow, nozzle and position, atomization air volume and pressure, binder spray rate, etc on fluid bed granulation process. - Validated screen-sizes and milling rates (pre-granulation), dry blend mixing times (pre-granulation), the quantity and rate of addition of the granulating vehicle, the specific granulating time(s), the temperature and air flows employed during the drying process, loss on drying of the granules, screen-sizes and milling rates (post-granulation), times and speeds used during all blending operations, and all coating parameters and conditions during initial formulation. - Successfully Analyzed Factors affecting the formulation of sustained release potassium chloride tablets such as Effect of polymer concentration, etc. - Optimized oral solid dosage pharmaceutical process by analyzing process parameters and product attributes for different unit operation. - Successfully Analyzed mixer load, granulation fluid addition Rate, total amount of granulation fluid, impeller/chopper speed, and wet mix time and observe product attributes such as granulation end point, torque, granule size distribution, drying rate, and dissolution for wet granulation. - Successfully Analyzed load, inlet temperature, bed temperature, airflow rate, %RH of drying and observe product attributes such as moisture content(LOD) as a function of time, drying time, and end point. - Successfully Analyzed effect of process parameters on granular properties. - Troubleshot film coating defects, identify flaw causes and provide remedy. - Compared coating methods such as sugar coating, film coating and compression coating. - Successfully Analyzed control variables and measured responds for each process step such as pre blending, granulating, drying, sizing, blending and tableting. - Developed water system for USP WFI and Optimized film coating components including polymer, plasticizer, pigment/opacifier and vehicle. Selected plasticizer in different categories such as polyols, organic ester and Oils/glycerides. Compared pigment and dyes. Provided energy conservation solutions such as adding exchanger to recover the heat from tablet coating system dry air exhausting to the atmosphere at the inlet of the coating pan. - Successfully Avoided recirculation of the exhausted air through the drying process due to possible contamination of the product and high solvent or moisture content of drying air. Slashed $3M from costs through process improvement

2015-2016 Monolith Materials, Redwood City, California Contract Engineering - Developed innovative, cost effective, and environmentally sustainable technologies that convert natural gas into chemicals and materials for customers around the world. Utilized Six Sigma methodology defining, measuring, analyzing, improving and controlling the process. - Successfully started up and shut down Seaport Plasma Carbon black Pilot Plant - Programed, troubleshot and optimized the process and utilities control systems in manufacturing processes so they can compress project schedule, detect off spec product and detect machinery health. Supported DCS system and troubleshot instrument malfunction. Slashed $1.5M cost

2014-2015 TRF Energy Solutions, Houston, TX Contract Engineering - Successfully Fabricated and commissioned Process Equipment for 18 sites

2014 CDI Corporation, Houston, TX Contract Engineering Played Key roles in eight projects: Kinder Morgan, Export Terminal, Pasadena, TX, NGL Plant Eaglebine Project, PSV UpGrade, Huntsville, TX, Yoakum Compressor Station, Huntsville, TX; KMYY, Sino 2014 Silane FBR Granular Polysilicon, Led in front-end engineering for a 1,000 MTPY Fluid Bed Reactor, a third-generation Solar technology; Huntsman, Reactor Upgrade, Conroe, TX Responsible for process studies of Polyol Reactor upgrades and E6 OSP Diversification Project, Port Neches, TX; Solvay USA, Solvay DAWN Project, Pasadena, TX, Supervised to build and operate a large-scale alkoxylation unit in Pasadena, Texas; BASF, VTA Skid Installation, Freeport, TX, Managed all aspects of the work of process studies covering alternative configurations to recovery heat in Crystallization Sterol Plant. Performed Heat exchanger sizing and Optimized tube pitch and configuration to enhance efficiency and slashed $100,000 cost

2012 -2014 Fluor Corporation, Sugar Land, TX Process Engineer Played key role in nine Projects: Sasol North America, Inc. Motivated in front-end engineering for a 1500 kTA ethane cracker and five derivative units (LDPE,LLDPE, EO/MEG, Guerbet, Ziegler, ETO); PEMEX-Fluor Salamanca Refinery Expansion, Salamanca, Guanajuato, Mexico; Wanhua Chemical Group Co, LTD MDI project. Aided in developing a large MDI project in TX (capacity is 400K MT/y) proposal; HQC Yuhuang Chemical, EG FEED Project, Responsible for setting up of 2x300,000 mt/year polymer grade EG project with NG as feed located in Texas; Exxon Neftegas Limited, Odoptu OS2, Sakhalin, Russia; BP-Husky Refining LLC, Toledo Refinery Small Projects, Toledo, OH; Marathon Petroleum Co., FCCU Flue Gas Reliability Study, Garyville, LA; BG Group NGL Marine Export Facility Study, Lake Charles, LA; Conoco Phillips ULSD Project, Lake Charles, LA

2011-2012 Oil Field Development Engineering, LLC, Houston, TX Facilities Engineer - Played key role in Helix Project and Castor Project

2010-2011 Performance Coatings International, West Caldwell, NJ Chemical Engineer - Evaluated organic/inorganic compounds for chemical and physical properties, composition, structure, relationships, and reactions. - Gained experience in use of chromatography, spectroscopy, and spectrophotometry while upgrading equipment, formulas, processes and analytical methods. Generic Recombinant Human Tissue Plasminogen Activator (tPA) Project, Cornell University, Ithaca, NY 2010 - Lead cost reduction solution by utilizing the highly engineered process of the simulated moving bed (SMB) process for implementing chromatographic separation to separate one chemical compound or one class of chemical compounds from one or more other chemical compounds to provide significant quantities of the purified or enriched material instead of using simple (batch) chromatography. - Identify Key factors of both high-density base matrix and salt-tolerant ligand adsorbent to enhance the efficiency of expanded bed adsorption and minimizing dilution arising from biomass or viscosity in feedstock and reducing dilution buffer consumption through high-density base matrix and eliminating dilution of feedstock step through the lack of sensitivity of the ligand to ionic strength and salt concentration. - Selected and compared chromatographic methods for separating and purifying proteins through physical properties that vary from one protein to the other, including size, charge, hydrophobicity, and specially binding capacity including separation method through size exclusion(gel filtration) chromatography (SEC) based on the difference of protein size or shape, took advantage of the charge-charge interaction between protein and ligand through Ion exchange chromatography, took advantage of the hydrophobic interaction between protein and ligand through hydrophobic interaction chromatography (HIC) or reversed-phase chromatography (RPC), utilized specific binding between protein and ligand through affinity chromatography (AC) and analyzed the advantage of the reduced desorbent consumption of SMB chromatography compared with fixed bed chromatography. - Compared the cost of batch and CSTR (4 months per run) bioreactor operations. - Designed a reverse osmosis/deionized water purification system to supply all process water. - Determined the steam requirements for sterilization of the bioreactors. - Did an economic opportunity exist for the production of generic tPA - Estimated the actual production cost per 100 mg/dose to make tPA. - Specialized in pharmaceutical product design, synthetic chemical drugs and genetically engineered drugs. - Researched in synthetic route, starting materials and selection of reactions. - Carried out small scale experiments to predict the genetic rates and conversions - Scaled up from lab to pilot plant to manufacture sufficient quantities of product for clinical trails. - Conducted process simulation, equipment sizing and cost estimation. - Specialized in generic engineering drugs, identify the target protein and the gene sequence that codes for the protein, with the knowledge of the disease and work backwards to find a protein that inhibits the chemical reaction involved in that disease. Measured the quantity and purity of the protein expression, and determine the rate and conversion of the protein growth and the purification of the yields which are the basis of design cultivation, fermentation and separation equipment. - Employed automated lab benches and permitting hundreds and thousands cell clones to be evaluated experimentally in parallel

2008 China Petro Dalian Factory, Dalian, China Intern Chemical Engineer - Tasked to troubleshoot chemical manufacturing processes, assess chemical equipment and perform research for development of improved chemical manufacturing methods. E DUCATION Cornell University, Ithaca, NY, Masters in Chemical Engineering Dalian University of Technology, Dalian, China, Bachelors in Chemical Engineering