Research Scientist
1 week ago
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
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Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for new products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.
Job Responsibilities- Performs validation of analytical testing procedure for drug substance and drug product.
- As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
- Conducts other tests required for dosage submissions.
- Documents and reports results as per established SOP's.
- Provides technical support to other department in response to deficiency letters from regulatory agencies.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours 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, Health and Environment policies, and HR policies.
- Liases at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and to understand their needs.
- Refers more contentious issues, with recommendations, to Supervisor
- Performs all work in accordance with all established regulatory, compliance and safety requirements.
- Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
- All other relevant duties as assigned.
- Education
- A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
- Knowledge, Skills and Abilities
- Knowledge of wet chemistry, analytical bench techniques, Window-based software.
- Knowledge of automated data acquisition systems is an asset.
- Knowledge of Auto/Manual dissolution test is an asset.
- Working knowledge of GC is an asset.
- Good written and verbal English communication skills.
- Experience
- BSc with 5 years or MSc with 3-4 years' 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.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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