Manager Chemist

Bhautik Shah

Email: *********@*****.*** Phone: 908-***-**** 1746 Holly road, North Brunswick, NJ.

SUMMARY

Analytical Chemist with extensive expertise in modern analytical instrumentation supporting Quality Control and R&D. Experienced in all aspects of physical and chemical analysis of active pharmaceutical ingredients, drug products, raw material, and excipients. Able to collaborate with any team and a dependable individual contributor. utilize my skills and experience in Pharmaceuticals formulations, petrochemicals & chemical corporations.

TECHNICAL SKILLS

HPLC/UHPLC, GC, LCMS for Assay, Impurity, Validation of analytical test method and transfer of analytical methods.

Firm Knowledge of FDA, ICH, and EMA

Skillful in using Waters HPLC/UPLC Acuity-H, LCMS, GC, UV, FT-IR, Karl-Fisher Titrations, Potentio-Metric Titrations, Thermo-Fisher Dionex and shimandzu.

Expert in Waters Empower 2/3, Chromeleon 7, and Chemstation.

PROFESSIONAL EXPERIENCE

Akorn Pharmaceuticals March 2017 - present

Validation Chemist II

●Partake in project teams and actively represents ATS to meet project commitments and milestones.

●Maintain and develop scientific awareness regarding compendial updates and changes.

●Perform routine testing of APIs, Excipients, Raw Materials, and Drug Products in accordance with cGMP, USP/NF/EP/BP compendia while following standard operating procedure.

●Successfully accomplish executing method validation and method transfer.

●Fulfilled validation for APIs assay and impurities

●Validated method for chloride content by volumetric-potentiometric titration method.

●Train Junior chemists with analytical techniques for all the analytical laboratory instruments, like HPLC, GC, Potentio-Metric Titration, etc.…

Lead projects independently with minimal supervision.

Sun Pharmaceuticals October 2015 – March 2017

Chemist II

●Worked in cGLP and cGMP environment.

●Used USP, JP and EP to perform in house testing methods on Drug substances, and drug products.

●Utilized techniques of HPLC, GC, and wet chemistry tests in agreement with USP.

●Maintained full compliance with all cGMP Regulations and internal SOPs.

●Trained junior chemists with analytical techniques for all of the analytical laboratory instruments.

●Perform routine testing of APIs, Excipients, Raw Materials, and Drug Products in accordance with cGMP, USP/NF/EP/BP compendia while following standard operating procedure.

AUROBINDO PHARMACEUTICALS January 2011 – October 2015

Chemist I

●Worked in cGLP and cGMP environment.

●Used USP, JP and EP to perform in house testing methods on Drug substances, and drug products.

●Utilized techniques of HPLC, GC, and wet chemistry tests in agreement with USP.

●Maintained full compliance with all cGMP Regulations and internal SOPs.

●Trained junior chemists with analytical techniques for all of the analytical laboratory instruments.

●Perform routine testing of APIs, Excipients, Raw Materials, and Drug Products in accordance with cGMP, USP/NF/EP/BP compendia while following standard operating procedure.

Safet-Kleen System. January 2010 – December 2010

QC Chemist

●Sample preparation and analysis of a variety of materials such as fuel oil.

●Conducted oil analysis from in-process samples through re-refining process and certified finished lubricants.

●Performed analytical tests including GC/FID,ECD for PCB’s, HVOC and simple distillation, flash point. Viscometry, density measurement, PH, Karl Fisher water analysis, bomb, kinematic viscosity, calorimetry, titration for total chlorine, and VOC analysis by GC-MS.

●Recorded data from analyses into lab information system database.

●Performed QC experiments daily.

●Completed QA/QC logs and preventive maintenance records related to analysis for traceability. Assisted Laboratory Manager, Senior Chemist and technicians with daily laboratory activities.

●Responsible for the maintenance and calibration of Laboratory equipment. Knowledgably in ASTM standards.

●Ability to work effectively under pressure, while directing numerous projects concurrently with different deadlines.

AccuMed/ H.H.&P May 2008 – January 2010

QC Chemist

●Managed all lab instruments like U.V, F.T.I.R, IR, Spectrometer, GC(FID), HPLC, Dissolution, KF Titrate. Performed Wet analysis as well as volumetric solutions standardization and documentation.

●Calibrating melting apparatus, Viscometer, Analytical balance, pH meter, Karl Fischer, UV, FITR.

●Performing tests on in-process samples, finish product, stability sample, and process validation sample utilizing USP/NF, FCC method.

Indian Petrochemicals Co rp LTD. May 1984 – April 2007

Lab Chemist

●Knowledge of GC(FID) analysis of HVOC, VOC, PCBs, etc. for various Petroleum Hydrocarbon..

●Analysis of BTW,APHA color,KF.

●Working Knowledge of PILOT PLANT operation for various Hydro carbon fractionations cut.

●ASTM distillation of various Petroleum products, Flash point determination both by closed cup and by seta cup, bulk density etc.

●Handled loading and unloading Hydro Carbons like Butadiene 1:2, Butane-1 and Hydro Carbon off site storage and utility.

●Worked closely with hazardous and explosive chemicals like DEAC. (Di Ethylene Aluminum Chloride).

●Prepared of organic acid slurry (LABS) by sulfonation of LAB (Linear alkyl benzene).

●Trained on HAZWOPER as per requirement

EDUCATION

S.P. University 1980-1984

B.S in Chemistry

Contact this candidate