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.
With guidance of Scientist, Analytical Development, responsible for performing all activities in early development research, analytical method development and validation for new products, comprehensive testing of API and finished dosages, and preparation of regulatory submission documentation. Acts as a key member in the project working team.
- Prepares working plan for assigned projects and provides timeline to Scientific Leader.
- Develops stability indicative analytical methods for drug substance and finished product.
- Works with Scientific Leader to prepare analytical methods, validation protocols and technical reports.
- Performs validation of analytical testing procedure for drug substance and drug product including dissolution methods.
- Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines.
- Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation.
- Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution.
- Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.
- Conducts other tests required for dosage submissions.
- Conducts lab investigations for OOS and OOT results.
- With guidance of scientists, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products.
- Documents and reports results as per established SOP’s.
- Provides technical support to other department for the issues related to the stability of drug substance and drug product or for the responses to requirements of regulatory agencies.
- Work as a member of a team to achieve all outcomes.
- Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time.
- Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements.
- Ensures all instruments assigned with responsibility within group/department are well maintained.
- Demonstrates corporate values in the performance of the work and interactions with others.
- Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.
- 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.
- Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
- Knowledge, Skills and Abilities
- knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus.
- Wet chemistry and analytical bench techniques.
- 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 LIMS is an asset.
- Good written and verbal English communication skills.
- BSc with 5 years or MSc with 4 years or PhD with 2 years’ experience in a pharmaceutical lab in an R&D environment.
- Chromatographic method development and validation.
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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