Senior 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, responsible at project level for all activities in AR&D-Test Centre including method validation for new products, testing of PI, in-process, stability samples and finished dosages, and generating regulatory submission documentation. Acts as a key member in the project working team and provides support to junior chemists. Also, oversees lab activities in absence of Asst. Manager.
Job Responsibilities- Performs validation of analytical testing procedures for drug substance and drug product
- Ensures 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.
- Performs routine tests for drug substance release, drug product release , stability samples and in-process samples. .
- Conducts lab investigations for OOS and OOT results.
- Conducts other tests required for regulatory submissions.
- Guide junior chemists in complex testing and investigation
- 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.
- Develops and manages strong relationship with internal customers.
- 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
- Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
- With guidance from supervisor, performs trouble-shooting on complex issues
- Oversees the resolution of more complex issues related to the project.
- All other relevant duties as assigned.
- Education
- A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
- Knowledge, Skills and Abilities
- Sound working and theoretical knowledge of chromatographic systems
- Knowledge of UV, IR, wet chemistry, potentiometric titration, analytical bench techniques, Window-based software, and automated data acquisition systems.
- Knowledge in HPLC method development and method validation.
- Excellent written and verbal English communication skills.
- Leadership skills are an asset.
- Experience
- BSc with 5 years or MSc with 4 years or PhD with 2 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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