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Chemist, Analytical Product/Method Life Cycle Management Specialist
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 key member of the Analytical Product/Method Life Cycle Management team, you will be responsible for evaluating new API sources, investigating commercial methods, and developing analytical methods for new API sources and commercial specifications. You will also conduct comprehensive testing of API and finished dosages, and generate regulatory submission documentation.
Key Responsibilities- Validate analytical testing procedures for drug substance and drug product under the guidance of a senior chemist.
- Perform initial testing and stability sample testing as per specifications.
- Investigate unexpected issues and provide solutions to resolve findings.
- Conduct other tests required for dosage submissions.
- Document and report results according to established SOPs.
- Provide technical support to other departments for responses to regulatory agency requirements.
- Refer contentious issues to the Scientific Leader with recommendations.
- Work collaboratively as a team member to achieve all outcomes.
- Adhere to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies, and HR policies.
- Education: Recognized post-secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or a related field.
- Knowledge, Skills, and Abilities:
- Knowledge of HPLC method validation.
- Knowledge of wet chemistry, analytical bench techniques, and Window-based software.
- Knowledge of automated data acquisition systems is an asset.
- Working knowledge of GC is an asset.
- Good written and verbal English communication skills.
- Experience:
- BSc with 1 year or MSc with 0 years or PhD with 0 year experience in a pharmaceutical lab in an R&D environment.
At Apotex, we are committed to fostering an inclusive, accessible work environment where all employees feel valued, respected, and supported.
We offer accommodation for applicants with disabilities as part of our recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
