Post : Research Scientist
Job Summary
Under supervision of Team Leader or Group Leader or Dy.Manager, responsible for developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for the analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques. Responsible for interpreting data and completing the required reports and documentation
Under supervision of Team Leader or Group Leader or Dy.Manager, responsible for developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applies assay for the analysis of drugs and metabolites in biological fluids involving simple to complex analytical techniques. Responsible for interpreting data and completing the required reports and documentation
Job Responsibilities
• 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
Additional Information:
Location: Bangalore, KA
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Bioanalytical
End date : 20th June, 2018
Location: Bangalore, KA
Education: M.Pharm, M.Sc, Ph.D
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Bioanalytical
End date : 20th June, 2018
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