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Chemist, Research and Development
2 months ago
Apotex Inc. is a leading global health company that specializes in the development and manufacturing of high-quality, affordable medicines for patients worldwide. With a strong presence in over 75 countries, Apotex employs a diverse team of professionals in various fields, including research and development, manufacturing, and commercial operations.
Job SummaryAs a key member of our Analytical R&D team, the successful candidate will be responsible for performing a range of activities in analytical method development and validation, as well as conducting comprehensive testing for API evaluation, formulation evaluation, and API releasing for NPD processes and submissions.
Key Responsibilities- Method Development and Validation: Develop and validate analytical methods for drug substance and finished product, ensuring accuracy and precision in compliance with laboratory SOPs and guidelines.
- Testing and Evaluation: Perform all analytical tests for drug substance, including assay, related compounds, identifications, and wet chemistry for API evaluation.
- API Releasing: Conduct all analytical tests for API releasing, including assay, degradation products, dissolution, and physical testing.
- Lab Investigations: Conduct investigations for OOS and OOT results, documenting and reporting results as per established SOPs.
- Technical Support: Provide technical support to other departments for issues related to the stability of drug substance and drug product or for responses to regulatory agency requirements.
- Team Collaboration: Work 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.
- Instrument Maintenance: Ensure all instruments assigned with responsibility within the group/department are well maintained.
- Compliance: Demonstrate corporate values in the performance of work and interactions with others, ensuring personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Education: Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field.
- Knowledge and Skills: Knowledge of instrumentation such as HPLC, GC, and IC, including Chromatographic Data Systems, UV, IR, and wet chemistry. Working knowledge of GC or LIMS is an asset.
- Experience: Minimum 2 years' experience in a pharmaceutical or analytical lab, preferably in an R&D environment.
