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.
Under the supervision of the AR&D; Group Leader, conducts the activities related to the development/optimization of analytical methods and specifications for pharmaceutical actives as part of new product development or product life cycle management activities.
- Tests R&D; samples as and when required using various analytical techniques including HPLC/UPLC, GC, UV, IR, ROI, KF, IC, Auto titration, and any other standard Pharmacopoeial test methodology.
- Carries out work related to analytical method development, cleaning validation studies, and standard certification.
- Reports all testing results and deviations encountered during testing.
- Properly documents analytical data and information as directed, and reviews data for accuracy and completeness, and presents technical data in an organized manner.
- Assists senior staff with analytical method development activities and helps R&D; meet overall project deadlines.
- Promptly identifies and discusses problems related to instruments and methods of analysis with the Group Leader.
- Identifies the need for chemicals, gases, standards, glassware, and other supplies. Maintains an organized and safe laboratory environment
- Operates laboratory instrumentation such as, but not limited to, HPLC/UPLC, GC, KF, UV, IR, Autotitrator, etc.
- Develops proper techniques and operational expertise, including basic troubleshooting skills, with key laboratory instrumentation.
- Develops ability to critically assess results for accuracy and precision; suggests or determines critical parameters causing poor or inconsistent results.
- Continuously upgrades and adds to analytical skill set to include the ability to work with new instrumentation and the ability to learn and apply new analytical techniques (both instrumental and wet chemical).
- 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
- Sc. in Chemistry or B.Sc. in Chemistry with a minimum two years of experience in a related field or CET degree (or equivalent) with a minimum five years of experience in a closely related field.
- Knowledge, Skills and Abilities
- Experience operating instruments such as HPLC/UPLC, GC, IC, UV, IR, KF, Potentiometric Titrator etc.
- Experience with standard wet chemistry techniques routinely used in an analytical lab setting as applied in the pharmaceutical field.
- Familiar with cGMP.
- Familiar with USP, BP, EP, and ICH guidelines and procedures.
- Exposure to Method Development and Method Validation is an asset.
- The ability to work as a member of a team.
- Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
- The willingness to upgrade knowledge/education on an on-going basis.
- Good communication skills, both verbal and written.
- Knowledge of Windows, Microsoft Word, Excel, Empower and/or Chemstation/Chemstore software, LabX, Chromeleon.
- Sc. in Chemistry - minimum two years of experience in a related field
CET degree (or equivalent) - minimum five years of experience in a closely related field
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.
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