About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, creative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Under supervision of reporting 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 with current regulatory ( DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
To work with the assigned project lead for Bioanalytical method development, Bioanalyitcal Method validation and Routine batch sample analysis (RBSA).
Involves in preparation of project specific solutions and sample preparation.
Documents all the work and results of all assignments as required.
Verifies and saves acquired results in Chromatography Data acquisition systems.
Creates sample sequences in Watson LIMS.
Performs Incurred sample reanalysis (ISR) selection, when required.
Performs Laboratory Investigation, and as required involves in Laboratory Investigation Report (LIR) preparation.
Operates general laboratory equipment and instrume
📌 Lead Research Scientist (India)
🏢 Apotex
📍 India