Chemist, Analytical Development

2 months ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs nearly 7,200 people in manufacturing, R&D, and commercial operations.

Job Summary

As a Chemist, Analytical Development, you will work under the supervision of a Scientist, Analytical Development, to develop and validate analytical methods for drug substances and finished products. Your responsibilities will include:

  • Preparing working plans for assigned projects and providing timelines to the Scientific Leader.
  • Developing stability-indicative analytical methods for drug substances and finished products.
  • Collaborating with the Scientific Leader to prepare analytical methods and technical reports.
  • Validating analytical testing procedures for drug substances and drug products, including dissolution methods.
  • Ensuring analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision, in compliance with laboratory SOPs and guidelines.
  • Performing all analytical tests for drug substances, including assay, related compounds, identifications, and wet chemistry for API evaluation.
  • Performing all analytical tests for PE/PO samples, including assay, degradation products, and dissolution.
  • Performing all analytical tests for API releasing, including assay, degradation products, dissolution, and physical testing.
  • Conducting other tests required for dosage submissions.
  • Conducting lab investigations for OOS and OOT results.
  • Documenting and reporting results as per established SOPs.
  • Providing technical support to other departments for issues related to the stability of drug substances and drug products or for responses to regulatory agency requirements.
  • Working as a member of a team to achieve all outcomes.
  • Developing and maintaining strong relationships within Analytical R&D to ensure project delivery on time.
  • Participating in departmental housekeeping and other pertinent duties as assigned, in accordance with safety and GMP requirements.
  • Ensuring all instruments assigned with responsibility within the group/department are well maintained.
  • Demonstrating corporate values in the performance of work and interactions with others.
  • Performing additional related duties as assigned, in accordance with job responsibilities and necessary departmental objectives.
  • Working in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstrating behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Ensuring 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 a related field.
  • Knowledge, Skills, and Abilities: Knowledge of instrumentation such as HPLC, GC, and IC, including Chromatographic Data Systems. Knowledge of UV, IR, and wet chemistry. Knowledge in HPLC method development and method validation. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of GC or LIMS is an asset. Good written and verbal English communication skills.
  • Experience: Minimum 2 years' experience in a pharmaceutical or analytical lab, preferably in an R&D environment.

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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