Research Scientist, Analytical Development

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.

Job 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
  • BSc with 5 years or MSc with 3-4 years’ experience in a pharmaceutical lab in an R&D environment.
  • Chromatographic method development and validation.