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Chemist, Analytical Development
2 months ago
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 almost 7,200 people in manufacturing, R&D, and commercial operations.
Job SummaryAs a Chemist, Analytical Development, you will be responsible for performing analytical method development and validation, as well as conducting comprehensive testing for API evaluation, formulation evaluation, and API releasing for NPD process and submission.
Key Responsibilities- Develop and implement analytical methods for drug substance and finished product.
- Work with the Scientific Leader to prepare analytical methods and technical reports.
- Perform validation of analytical testing procedures for drug substance and drug product.
- Ensure analytical methods validation is conducted according to approved validation protocol in a timely manner.
- Conduct all analytical tests for drug substance, including assay, related compounds, identifications, and wet chemistry for API evaluation.
- Conduct all analytical tests for PE/PO samples, including assay, degradation products, and dissolution.
- Conduct all analytical tests for API releasing, including assay, degradation products, dissolution, and physical testing.
- Document and report results as per established SOPs.
- Provide technical support to other departments for issues related to the stability of drug substance and drug product or for responses to regulatory agencies.
- Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
- Knowledge of instrumentation such as HPLC, GC, and IC, including Chromatographic Data Systems.
- Knowledge of UV, IR, and wet chemistry.
- Minimum 2 years' experience in a pharmaceutical or analytical lab, preferably in R&D environment.
At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.
