Chemist, Research and Development
2 months ago
About Apotex Inc.
Apotex Inc. is a global health company that specializes in the development and production 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 Summary
As a key member of the 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 new product development (NPD) processes and submissions.
Key Responsibilities
- Develop and implement working plans for assigned projects, providing timely updates to the Scientific Leader.
- Design and develop stability-indicative analytical methods for drug substances and finished products.
- Collaborate with the Scientific Leader to prepare analytical methods and technical reports.
- Validate analytical testing procedures for drug substances and drug products, including dissolution methods.
- Ensure analytical methods validation is conducted in accordance with approved validation protocols, with a focus on accuracy, precision, and compliance with laboratory SOPs and guidelines.
- Perform all analytical tests for drug substances, including assay, related compounds, identifications, and wet chemistry for API evaluation.
- Perform all analytical tests for PE/PO samples, including assay, degradation products, and dissolution.
- Perform all analytical tests for API releasing, including assay, degradation products, dissolution, and physical testing.
- Conduct other tests required for dosage submissions.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results.
- Document and report results in accordance with established SOPs.
- Provide technical support to other departments for issues related to the stability of drug substances and drug products, or responses to regulatory agency requirements.
- Work collaboratively as a member of the Analytical R&D team to achieve project outcomes.
- Develop and maintain strong relationships within the Analytical R&D team to ensure project delivery on time.
- Participate in departmental housekeeping and other relevant duties as assigned, in accordance with safety and GMP requirements.
- Ensure all instruments assigned to the team are well-maintained.
- Demonstrate corporate values in the performance of work and interactions with others.
- Perform additional related duties as assigned, in accordance with job responsibilities and departmental objectives.
- Work safely and collaboratively as a team member to achieve project outcomes.
- Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
- Ensure 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.
Requirements
- Education: Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field.
- Knowledge, Skills, and Abilities:
- Knowledge of instrumentation, including HPLC, GC, and IC, as well as Chromatographic Data Systems.
- Knowledge of UV, IR, and wet chemistry.
- Knowledge of 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.
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