Research Scientist, Analytical R&D

As a member of the Analytical Development team at Apotex Inc., you will be responsible for planning and executing various analytical method development and validation activities for new products, ensuring compliance with regulatory and safety requirements. You will review laboratory data, instrument logbooks, and reports, and initiate departmental Corrective and Preventive Actions (CCR) to track progress through the Quality Management System (QMS). Your key responsibilities will include: - Preparing working plans and timelines for assigned projects - Developing stability indicative analytical methods for drug substances and finished products - Ensuring compliance with cGLP, documentation, and implementation of quality systems - Performing analytical tests for drug substances, PE/PO samples, and API releasing - Conducting lab investigations for out-of-specification (OOS) and out-of-trend (OOT) results - Participating in technology transfer and collaborative validation activities - Troubleshooting complex issues related to the stability of drug substances and products Qualifications required for this role: - A graduate/post-graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field - Knowledge of instrumentation such as HPLC, GC, spectrophotometer, dissolution apparatus, and wet chemistry techniques - Experience in chromatographic method development and validation - Familiarity with regulatory guidelines, cGMP activities, and document preparation/review - Excellent written and verbal English communication skills At Apotex, we prioritize inclusivity and accessibility in the workplace, ensuring that all employees feel valued, respected, and supported. We also provide accommodations for applicants with disabilities during the recruitment process. If you require any accommodations for interviews or testing, please inform us in advance. Join our team at Apotex to contribute to the production of high-quality, affordable medicines for patients worldwide.,