Job Description

About Apotex Inc. Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

• Under supervision of reporting manager, responsible for assisting in developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids.

Job Responsibilities

• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre\xe2\x80\x99s, 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, when required.

• Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.

• Performs raw data compilation, assists in project wrap-up.

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science.
• Knowledge, Skills and Abilities
  • Knowledgable of or experience with simple analytical or laboratory processes using HPLC or LC-MS/MS.
  • Fundamental understanding of concepts of GLP/SOPs, regulatory guidelines.
  • Good skills in MS Office.
  • Good in Communication skills.
  • Flexible to work
  • Strives to drive projects related to Bioanalytical effectively.
• Experience
  • Minimum 1-2 years experience in Bioanalytical.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.