Patel - Lab Chemist - Mississauga, ON, Canada

Kamini Patel

Mississauga, ON, Canada

Services

Lab Chemist

Summary:

 A highly analytical and resourceful individual with two year and five month experience as an research associate in analytical development lab in research and development sector in a biopharmaceutical company
 Knowledge of the development, qualification, validation and report preparation of analytical methods such as HPLC based methods, electrophoresis methods, ELISA, to establish the purity and stability of drug substance and drug product
 Knowledge of target protein and impurity characterization
 Operational knowledge of analytical instrumentation like HPLC, UV-VIS spectrophotometer, UPLC, DIONEX, microplate plate reader, pH meter, osmometer
 In-depth knowledge of purification and characterization of biosimilar products and their production in small and large scale in GMP facility
 Knowledge of Endotoxin measurement technique
 Knowledge of ICH guidelines, US and Europe pharmacoea
 Great ability to function well within multidisciplinary teams
 Strong technical knowledge and outstanding communication skills
 Strong problem solving and troubleshooting skills
 Knowledge of a range of analytical techniques to conduct research and determine structure and purity of organic compounds
 Remarkable ability to work in a multidisciplinary, high-intensity environment.
 Strong analytical and research skills; self motivated, innovative thinker and decision maker
 strong planning, organizing and monitoring abilities - an efficient time-manager
 Hands on experience of preparations of SOP, development-qualification-validation report, specifications and process transfer documents
 Highly proficient in use of all applications of Microsoft Office with other basic programs
 Personal qualities: Analytical – precise – thorough – curious – patient – independent

Work History

edia Inspector

Ciba vision

December 2012 - February 2013

• ¬Media inspection of incubated containers (filled with TBS for the process simulation testing or media fill)
• Recording of results and documenting observations in the media observation documents
• Ensuring the media reading room is clean and inspection tables are clean
• Acquire knowledge via media reading training and passing media reading evaluation test, relevant to the area of responsibility
• Keep track of media reading lab supplies and inform microbiologist/media reading supervisor to place order on timely manner to avoid back orders and delays
• Assist in the movement of boxes (of media filled containers) from incubators to ware house.

Research Associate

Intas Biopharmaceuticals Ltd.

February 2010 - June 2012

• ¬Worked on different biosimilar products (proteins) like PTH (Parathyroid hormone), Interferon alfa 2b, Pegylated interferon, Pegylated erythropoietin.
• Assigned to develop analytical methods such as HPLC based methods (SE-HPLC, RP-HPLC, IE-HPLC), ELISA (for host cell protein determination), host cell DNA estimation method (using picogreen dye) and electrophoresis based methods (SDS-PAGE, Immuno-transfer, IEF) to analyze the quality of biosimilar products.
• Qualification of all the analytical methods and report preparation.
• Prepared documents like Method development, qualification and validation protocols and reports. Also prepared specifications, SOPs and technology transfer documents.
• Carried out consistency batches and scale-up batches in-process as well as batch release samples.
• Provided support to quality control department for analysis of clinical trial batches and validation of methods.
• Provided analytical method development and validation of methodologies to support scale-up of processes from bench top to pilot-scale and, as required, technology transfers to commercial plants
• Carried out stability samples and stability study report preparation.
• Provided analytical support to different departments like Up stream processing, down stream processing, drug product development.

Rsearch Associate

Intas Biopharmaceuticals

February 2010 - June 2012

 A highly analytical and resourceful individual with two year and five month experience as an research associate in analytical development lab in research and development sector in a biopharmaceutical company
 Knowledge of the development, qualification, validation and report preparation of analytical methods such as HPLC based methods, electrophoresis methods, ELISA, to establish the purity and stability of drug substance and drug product
 Operational knowledge of analytical instrumentation like HPLC, UV-VIS equipment, UPLC, DIONEX, microplate plate reader, pH meter, osmometer
 Aware of all techniques associated with modern laboratory synthesis
 In-depth knowledge of purification and characterization of biosimilar products and their production in small and large scale
 Knowledge of documentation preparation and procedure required for process transfer
 Great ability to function well within multidisciplinary teams
 Strong technical knowledge and outstanding communication skills
 Strong problem solving and troubleshooting skills
 Knowledge of a range of analytical techniques to conduct research and determine structure and purity of organic compounds
 Remarkable ability to work in a multidisciplinary, high-intensity environment.
 Strong analytical and research skills; self motivated, innovative thinker and decision maker
 strong planning, organizing and monitoring abilities - an efficient time-manager
 Highly proficient in use of all applications of Microsoft Office with other basic programs
 Personal qualities: Analytical – precise – thorough – curious – patient – independent

Intas Biopharmaceuticals

Qualifications & Certifications

Advanced Pharmaceutical Instrumrntation

Seneca College

Master of Science

Ganpat University

Bechlor of Science

M. G. Science Institute

vivekanand

Ganpat University Kherva

University of Gujrat

Gujarat Cancer and Research Institute (GCRI)

Ganpat Univercity

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