AMIT KUMER SARKER
****-*** ******** ****** ***** : 647-***-****
Scarborough, ON M1L 3G1 E-mail : **********.**@*****.***
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Objective:
Keenly interested in pursuing a career as Chemist in Sterling-Hoffman Life Sciences
Highlights Of Qualifications:
* Master degree in Biochemistry, currently being evaluated by CES, University of Toronto
* Proven success in using chemical and instrumental techniques such as FT-IR, HPLC and UV Spectrophotometer
* 8+ years experience in routine analysis of pharmaceutical preparations and raw materials
* Good knowledge of cGMP, GLP, WHMIS and established compendia
* Proficiency in Microsoft Word, Excel, Power point and Laboratory software’s
* Excellent problem solving and troubleshooting techniques
* Excellent communication, organizational and leadership skills
Accomplishments:
* Generated flow chart on work instruction (WI) of machineries which improved
worker’s skills and reduced employee’s injury cases
* Created foil design for a drug packaging which improved drug shelf life time
* Improved Site Master File (SMF) which brought about increased in vendor numbers
Professional Skills:
ANALYSIS
* Performed chemical testing of raw materials using analytical instrumentation
including FTIR, UV-VIS, HPLC, Dissolution Apparatus etc
* Performed analysis of generic drugs as per compendia and in-house method
* Performed stability study of existing products and also accelerated stability
study for newly developed products
* Analyzed complex biochemical specimens such as different body fluids
DEVELOPMENT
* Developed in-house testing procedure of finished product
* Developed product formulation including lab and pilot batch production
* Identified cause of poor analytical performance and provided solution
* Maintained reference standards, working standards and laboratory reagents
IMPLEMENTATION
* Data analysis, report writing and sample archiving into Laboratory Information Management System (LIMS) and SAIL software’s
* Transferred technology of new products developed by R&D to
Quality Control department
* Determined stability of generic drugs using HPLC & UV Spectrophotometer
* Approved serological report, maintained liaison with technical staffs
* Supervised analysis and data interpretation related to patient samples
VALIDATION
* Validated analytical method developed in laboratory
* Calibrated laboratory instruments as per SOP
* Performed clinical validation of automated analyzers
* Summarized process validation report on pilot batch production
DOCUMENTATION
* Prepared product master file and registration dossier for export market
* Maintained documents as record of developed pilot batch
* Generated documents for in-process control (IPC)
* Conducted in house cGMP training and audit
* Prepared departmental objective and analysis achievement
* Assisted in manufacturing and quality control to resolve technical issues
* Planned and organized clinical laboratory tasks
Employment History:
* Lab Technician (Co-op) Present
Maxxam Analytics Inc., Mississauga, Canada
* Sr. R&D Chemist 2004-2008
NAVANA Pharmaceutical Ltd., Bangladesh
* Quality Control Chemist 1999-2004
The ACME Laboratories Limited., Bangladesh
* Lab Technician 1995-1998
Gastro Liver Hospital & Research Institution., Bangladesh
Training And Education:
* Certificate on WHMIS-Computer Based 2008
Maxxam Analytics Inc., Mississauga, Canada
* Laboratory Training on API 2006
Sreeker Consultant, Hyderabad, India
* Master Degree in Biochemistry 1991-1992
University of Dhaka, Bangladesh
* Bachelor Degree in Biochemistry 1988-1991
University of Dhaka, Bangladesh
Career portfolio and references are available upon request