Analytical Chemist

6 days ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a leading global health company based in Canada, committed to delivering high-quality medicines that improve patients' lives worldwide.

The company employs approximately 7,200 people across various functions, including manufacturing, research and development (R&D), and commercial operations.

Apotex medicines are accessible in over 75 countries globally, thanks to its focus on vertical integration, which enables the development and sale of generic, biosimilar, and specialty products.

Job Summary

  • Responsible for conducting thorough testing of raw materials, in-process materials, finished products, and stability samples with high accuracy and precision using analytical instruments and established procedures.
  • Collaborate with the Analytical Development department to perform co-validation of analytical test methods.
  • Provide audited stability summary reports for regulatory submissions and prepare/update stability schedules for various drug products.

Key Responsibilities

  • Under minimal supervision, analyze raw materials, in-process materials, finished products, and stability samples with a high degree of accuracy and precision using analytical instruments and established procedures.
  • Document results clearly in accordance with Standard Operating Procedures (SOPs).
  • Perform statistical analysis on test results as required.
  • Organize work efficiently and utilize time effectively.
  • Communicate technical information clearly, both verbally and in written form.
  • Assist in method transfer and validation under supervision, including intermediate precision tests.
  • Other responsibilities as assigned by the supervisor.

Technology/Instrumentation

  • Possess sound working knowledge of UV-VIS spectrophotometers, Karl Fisher titrators, Auto-titrators, HPLC, GC, IC, balances, vacuum ovens, microscopes, osmometers, density meters, Hunter scanners, and Auto-actuation stations.
  • Familiarity with more complex techniques as required.

Experimental or Methodological Design

  • Review specifications, test procedures, and SOPs prior to use and provide feedback as necessary.

Relationship with Internal/External Customers & Stakeholders

  • Act as a key team player and assist senior chemists with challenging tasks.
  • Liaise regularly with internal customers to understand their needs and keep them informed about work progress.

Problem Solving Analysis

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

Decision Making/Autonomy

  • Respond to queries from junior chemists and participate in training new staff as needed.

Leadership/Professional Development of Self & Others

  • Continuously upgrade technical knowledge by attending seminars or taking relevant courses.

Compliance & Due Diligence

  • Perform all activities in compliance with SOPs, cGMP, and SHE policies.
  • Participate in reviewing departmental policies, procedures, and standards impacting their area as required.

Job Requirements

  • Bachelor of Science in Chemistry or a related field.
  • Minimum 3 years of experience in pharmaceutical analytical laboratories.
  • Possess laboratory computer skills.
  • Operational and troubleshooting skills related to analytical instruments.
  • Familiarity with GMP, GLP, and WHMIS regulations.
  • Familiarity with Pharmaceutical compendia.

We at Apotex value diversity and strive to create an inclusive work environment where all employees feel valued, respected, and supported.

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