Post : Research Scientist-Bioanalytical
Job Description
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• Performs bioanalytical method development and validation for the quantification of drugs and metabolites.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Documents all the work and results of all assignments as required.
• Assists in the preparation of lab reports.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• To receive the plasma samples from the clinic and ensure their proper storage until further assay
• To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
• To oversee the raw data compilation and their archiving after completion of final reports.
• Performs routine maintenance on Mass Spectrometers and associated HPLC equipment.
• Applies assay for the routine batch analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.
• Performs additional related duties as assigned by Management
• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• Performs bioanalytical method development and validation for the quantification of drugs and metabolites.
• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
• Sets-up and ensures calibration of analytical systems and maintains instrument systems in good working order.
• Documents all the work and results of all assignments as required.
• Assists in the preparation of lab reports.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• To receive the plasma samples from the clinic and ensure their proper storage until further assay
• To write and revise SOPs as per need and maintain awareness of and adherence to all current SOPs.
• To oversee the raw data compilation and their archiving after completion of final reports.
• Performs routine maintenance on Mass Spectrometers and associated HPLC equipment.
• Applies assay for the routine batch analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques.
• Performs additional related duties as assigned by Management
Candidate Profile
• Minimum M.Sc. / M. Pharm / Ph.D
• 4 to 6 years of experience in Bioanalytical Laboratory.
• Knowledge of computerized data acquisition systems.
• Good knowledge of GLP requirements
• Minimum M.Sc. / M. Pharm / Ph.D
• 4 to 6 years of experience in Bioanalytical Laboratory.
• Knowledge of computerized data acquisition systems.
• Good knowledge of GLP requirements
Additional Information
Experience : 4-6 years
Qualification : M.Sc. / M. Pharm / Ph.D
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 25th December, 2018
Experience : 4-6 years
Qualification : M.Sc. / M. Pharm / Ph.D
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 25th December, 2018
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