Senior Analytical Chemist
2 weeks ago
About Apotex Inc.
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. Our company is committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.
Job Summary
As a Senior Analytical Chemist, 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 with accuracy and precision in compliance with laboratory SOP and guidelines.
- 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.
- Conduct other tests required for dosage submissions.
- Conduct lab investigations for OOS and OOT results.
- Document and report results as per established SOP's.
- Provide technical support to other departments for issues related to the stability of drug substance and drug product or for responses to requirements of regulatory agencies.
- Work as a member of a team to achieve all outcomes.
- Develop and maintain strong relationships within Analytical R&D to ensure that projects are delivered on time.
- Participate in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements.
- Ensure all instruments assigned with responsibility within group/department 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 necessary departmental objectives.
- Work in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate behaviors 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.
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