Quality Control Manufacturing
Resume:
Binalkumari Mistry
San Jose, CA 95148
*************@*****.***
Summary:
•Holds M.S Degree in Organic Chemistry. Team player and able to work under pressure, multitask and time management ability, attention to detail.
•Strong work experience of Analysis By various Methods in GMP Environment
•Employed different techniques for the component separation along with troubleshoot equipment and calibration.
•Utilize the HPLC and UV/visible spectrophotometer instrument for formulating and qualifying ESA products for bio-analytical applications conforming to FDA approval requirement.
•Ability to operate UV spectroscope and pH
•Ability to operate and handle sensitive IC and HPLC equipment for ion and biochemical analyses, Performing lab activities with accuracy such as in solutions and buffer preparation, pipetting, chromatography result analysis.
Education:
•M.S: Organic Chemistry, South Gujarat University, India 2008
•B.S: Chemistry, South Gujarat University, India 2003
Coursework Covered in M.S:
•Organic Chemistry, Organic Polymers, Theoretical and Natural Products Chemistry, Medicinal Chemistry, Industrial Chemicals and Analysis, Physical and Inorganic and Petroleum Chemistry, Instrumentation and analytical Chemistry. Laboratory Project Course Work in Organic Synthesis of basic Dyes and Drugs.
Skills:
•Ability to operate and handle sensitive IC and HPLC equipment for ion and biochemical analyses,
•Ability to operate UV spectroscope and pH
•Ability to interpret chromatography data
•Skilled to troubleshoot analytical equipment
•Skilled in packing analytical and guard columns of various dimensions, testing and validating chromatography consumables for production
•Ability to handle various sensitive organic, inorganic and bio- chemicals and standard laboratory equipment
•Ability to follow Standard Operating Procedures (SOPs) and design procedures as necessary.
•Knowledgeable and able to work with computers, MS office
•Ability to work independently and minimum supervision
•Team player and able to work under pressure, multitask and time management ability, attention to detail.
•Buffer and reagent preparation
•Pipetting and titration work
Work Experience:
ThermoFisher Scientific Jun 11 – Present
Resin Technician
•Synthesized several Cation Exchange Resins and Anion Exchange Resins, Packed and Tested on Chromatographic Equipment’s for separation of various cations from the analyte mixture, interpret data and troubleshoot as necessary for eventual transfer to column production and quality control
•Performed sulfonation reactions of raw resins to manufacture sulfonated resins for chromatographic applications. Performed scale up reactions as necessary
•Worked on the testing of resins followed by agglomeration with latexes and validating different kinds of latexes for ion-exchange applications.
•Prepared different kinds of appropriate eluents for analyzing various kinds of cations, anions and monoclonal antibodies.
•Interacted and worked with senior colleague within the division and across the division for inputs to trouble shoot and qualify several ion exchange resins and latex products.
•Analytical Reagents and Standards Kit
•Utilize the HPLC and UV/visible spectrophotometer instrument for formulating and qualifying ESA products for bio-analytical applications conforming to FDA approval requirement.
•Evaluate Peak areas, peak heights, retentions times of eluted ions with the given data sheets.
•Manufacturing Vitamin-D,CS/IS Standard Kits
•Manufacturing Catecholamine Standard Kits
•Manufacture Plasma Metanephrine and HMBA Standard kits.
•Preparation of various mobile phases for like Vitamin D mobile phase, MD-TM mobile phase, UTAC mobile phase etc.
•Worked in manufacturing various reagents for application towards cation exchange, anion exchange and carbohydrates analyses.
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