Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.
Post : Research Scientist I- Bioanalytical
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.
• 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.
• 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
Qualification : Ph.D, M.Pharm, M.Sc
Experience : 4 to 6 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Bioanalytical
End Date : 30th April, 2019
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