Manager Analyst

Shanthini Sivappiragasam

*** ***** ********, *********** ** L5W 1R3 647-***-**** adbro2@r.postjobfree.com

Summary

Detail-Oriented with expertise in handling the laboratory equipment including HPLC, UPLC, LC/MS, as well as coordinating testing and development. Adept at developing new applications and products, providing technical solutions. Practiced in instrument monitoring and analytical method performance.

Highlights

Calibration of lab instruments

Reviewing documentations and Calculations

Compound optimization

Expert in Bioanalysis, R&D and Validations

Lab maintenance expert

MS Office- Word, Excel, Power Point

Efficiency in time management

Fluency in English language

Experience

SENIOR BIOANALYTICAL ANALYST PHARMA MEDICA RESEARCH INC, MISSISSAUGA.

SEP 2009 – OCT 2019

·Responsible for providing analytical training to new employees, as well as completing the proper documentation, as per SOP.

·Developing, troubleshooting and validating bioanalytical methods for analysis of drugs and metabolites in biological fluids, finished products via HPLC, UPLC, LC-MS/MS for bioavailability, bioequivalence and toxicology studies

·Responsible for reviewing, documenting, analyzing and interpreting data and scientific problems in supports of HC, FDA, EMEA and ANIVISA.

·Responsible for reviewing final data, chromatograms, integration and analytical methods.

·Experience in the analysis of drugs and metabolites in biological fluids.

·Extensive expertise in the Extraction techniques, such as Solid Phase Extraction, Liquid-Liquid Extraction, and Protein Precipitation Extraction.

·Strictly followed the principle outlines in the company’s Standard Operating Procedures.

·Responsible for the operation of a variety of all laboratory equipment including HPLC,GC, LC/MS, LC-MS/MS instruments:

·Responsible for the calibration and maintenance balances, pH meters, pipettes, freezers, water system, equipment for sample extraction, evaporation and fume hoods.

·Responsible for the coordination of clinical and pre-clinical studies by ensuring pools and randomization charts are prepared and all required supplies are ordered.

·Responsible for training and supervising bioanalytical technicians on various analytical methods as well as approving their documentation.

·Responsible for preparing and maintaining Standard Operating Procedures (SOPs), as required by the company.

·Responsible for performing method validations and writing analytical method reports.

·Serve as liaison with the Principal Bioanalytical Investigator, QC and QA departments to ensure all lab documentation and work is conducted in compliance with GLP/GMP, SOPs and sponsor protocols.

BIOANALYTICAL ANALYST PHARMA MEDICA RESEARCH INC, MISSISSAUGA.

MAR 2007 – SEP 2009

·Developing, troubleshooting and validating bioanalytical methods for analysis of drugs and metabolites in biological fluids via HPLC, LC-MS/MS for bioavailability, bioequivalence and toxicology studies.

·Preparation of the calibration standards and quality control samples, and extracted biological samples by liquid-liquid extraction, protein precipitation and solid phase extraction methods.

·Responsible for performing validation of assays in accordance with Health Canada and FDA guidelines.

·Preparing stock solutions, internal standards, buffers, mobile phases and other reagents, as needed.

BIOANALYTICAL TECHNICIAN PHARMA MEDICA RESEARCH INC, MISSISSAUGA.

SEP 2005 – MAR 2007

·Preparation of calibration standards and quality control samples, and extracted biological samples by liquid-liquid extraction, protein precipitation and solid phase extraction methods.

·Preparation of buffers, mobile phases and other reagents, as needed.

·Processing data, integrated chromatograms manually for manager review.

·Ensure all lab documentation and work is conducted in compliance with GLP/ GMP and SOPs.

PACKAGING OPERATOR PATHEON BY THERMO FISHER SCIENTIFIC, MISSISSAUGA

APR 2004–SEP 2005

·Work various positions on the packaging line including capping, cartoning, packing shippers in compliance with GMPs requirements to meet production targets.

·Inspection of packaged products for presence and correctness of lot number, expiry date and general packaging appearance and completeness.

·Ensure line cleanliness practices, procedures, SOPs and packaging instructions are followed.

·Maintain a safe working environment and report potential hazards.

Education

INDUSTRIAL PHARMACEUTICAL TECHNOLOGY (CERTIFICATE) SENECA COLLEGE 2003

·Related coursework: Lab Assay Methods, Liquid Chromatography, Gas Chromatography, Mass Spectrometry, Microbiology, Product Formulation, Biochemistry, Pharmaceutical Chemistry, Inorganic and Organic Chemistry, Pharmaceutical Quality Assurance Basics, Regulatory Affairs

BSC HONOURS, UNIVERSITY OF JAFFNA, SRI LANKA 1994

·Majors: Chemistry, Botany and Zoology

·Bioequivalence studies, successfully assessed by University of Toronto Comparative Education Service for equivalency

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