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

• Responsible for testing of Raw Materials, In-Processes, Finished Products and Stability Samples.
• Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, Safe Work Procedures (SWPs) as well as Apotex’s Health, Safety and Environmental policies.

Job Responsibilities

• Under minimum supervision perform analysis of raw materials, In-processes, finished products and stability samples with high degree of accuracy and precision using analytical instruments and established analytical procedures.
• Document results clearly in accordance with SOP’s
• Provide statistical analysis on test results as required.
• Organize work efficiently and utilize time effectively.
• Communicate technical information in a clear and concise manner, both verbally and in written form.
• Under supervision, perform intermediate precision as part of method transfer in conjunction with AD method validation.
• Other responsibilities as assigned by the supervisor.

Technology/Instrumentation (type & complexity)

• Sound working knowledge of UV-VIS, IR spectrophotometer, Karl Fisher, Auto-titrator, HPLC, GC, IC, balances, vacuum oven, microscope, osmometer, density meter, Hunter scan and Auto-actuation station.
• In addition, more complex techniques as required.

Experimental or Methodological Design (if applicable)

• Review specifications, test procedures and SOP’s prior to use and provide feed - back as required.

Relationship with Internal/External Customers & Stakeholders

• Act as key player within the team and help senior chemist when difficult task is performed.
• Liaise regularly with their internal customers to understand their needs, and keep them current with work progress.

Problem Solving Analysis

• Solve routine problems independently
• Identify complex problems with instruments, specifications and test methods and report them to the senior level for corrective action.

Decision Making/Autonomy

• Respond to queries from junior chemist and participate in training new staff if required.

Leadership/Professional Development of Self & Others

• Continually upgrade technical knowledge by taking appropriate courses.

Compliance & Due Diligence

• Perform all activities in compliance with SOP’s, cGMP and SHE
• Participate in reviewing department policies, procedures and standards impacting their area as required.

Job Requirements

• Bachelor of Science in chemistry or related field
• Minimum one to three year of experience in pharmaceutical

analytical laboratory.

• Possess (a) Laboratory computer skills

(b) Operational and trouble shooting skills related to analytical instruments. (c) Knowledge of GMP, GLP and WHMIS (d) Good knowledge of Pharmaceutical compendia.


Competency

Proficiency Level (1-5)



Interpersonal Communication

2



Customer Focus

2



Time Management

3



Functional/Technical Skills

3



Team Work

3



Compliance & Regulatory Knowledge

2

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.