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Chemist, Analytical PLCM - Signet/Etobicoke

Date: Jan 8, 2022

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

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 guidance of Scientific leader, Analytical Product/Method Life Cycle Management, responsible for performing all activities in evaluation of new alternate API sources, investigations related to commercial methods, compendia method evaluations for any commercial products, laboratory support work for Manufacturing Technical Services and New Product Launch, analytical method development and validation for new API source and methods that are related to commercial specifications. Also responsible for closing validation gaps as per MLCM program for commercial test methods, comprehensive testing of API and finished dosages and generating regulatory submission documentation.  Acts as a key member in the project working team.

Job Responsibilities

  • Performs validation of analytical testing procedure for drug substance and drug product.
  • As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
  • Conducts investigation on unexpected issues as directed and provides solutions to resolve the findings.
  • Works with Scientific Leader to prepare analytical methods, and technical reports.
  • Possesses advanced knowledge of the instrumentation such as HPLC, GC and IC, including Chromatographic Data Systems. Knowledge of UV, IR, and Wet Chemistry.
  • Conducts other tests required for dosage submissions.
  • Documents and reports results as per established SOP’s.
  • Provides technical support to other department for the responses to requirements of regulatory agencies.
  • Refers more contentious issues, with recommendations, to Scientific Leader
  • Work as a member of a team to achieve all outcomes.
  • 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
    • Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
    • B.Sc or M.Sc or PhD.
  • Knowledge, Skills and Abilities
    • Knowledge of HPLC method validation.
    • Knowledge of wet chemistry, analytical bench techniques, Window-based software.
    • Knowledge of automated data acquisition systems is an asset.
    • Working knowledge of GC is an asset.
    • Good written and verbal English communication skills.

 

  • Experience
    • B.Sc with 3 years or MSc with 1 year or PhD with 0 year experience in a pharmaceutical lab in an R&D environment.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.