Research Scientist, Ad-arpl-ar&d Ar

**About Apotex Inc.**

**Job Summary**:

- 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.

**Responsibilities**:

- Prepares working plan for assigned projects and provides timeline to Deputy 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.
- 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 protocol 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 guidance of scientists, 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.
- 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.
- 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.

**Job Requirements**:

- 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, 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
- B