Senior Research Scientist, AR&D

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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• Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements.
• Review of laboratory data, instrument logbook and reports wherever applicable.
• Initiation of departmental CCR's and tracking the progress to execute the proposed changes through QMS system.
• Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites.
• Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation.

• Prepares working plan for assigned projects and provides timeline to Manager. 
• Develops stability indicative analytical methods for drug substance and finished product  
• Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. 
• Applies AQbD approach to analytical method development where applicable. 
• Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. 
• Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. 
• Responsible for method verifications and publishing of analytical methods. 
• Maintenance and archival of analytical method validation documents. 
• Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. 
• Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. 
• Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.  
• Conducts other tests required for dosage submissions. 
• Conducts lab investigations for OOS and OOT results. 
• Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise  
• To prepare General, Operation and Calibration Standard Operating Procedures. 
• Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. 
• Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. 
• Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. 
• With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. 
• To participate in the mandatory trainings to execute the day to day job responsibilities.
• Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP.
• Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. 
• Practice and up-gradation of knowledge with respect to cGMP. 
• Performs all work in accordance with all established regulatory and compliance and safety requirements. 
• Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. 
• Ensures all instruments assigned with responsibility within group/department are well maintained. 
• Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. 
• Work as a member of a team to achieve all outcomes. 
• 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 and Environment policies, and HR policies.   
• All other relevant duties as assigned.

• Education
  • A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. 
• Knowledge, Skills and Abilities
  • knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. 
  • Knowledge in HPLC method development and method validation. 
  • Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports.  
  • Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities 
  • Should possess troubleshooting knowledge on Instruments and analysis. 
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. 
  • Working knowledge of LIMS is an asset. 
  • Good written and verbal English communication skills. 
• 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. 
  • Chromatographic method development and validation.

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.