Senior Research Scientist - Stability Lab

Roles and Responsibilities

• 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.

Desired Candidate Profile

• 2-6 years of experience in a similar role within the pharmaceutical industry.
  
• Bachelor's degree (B.Pharma) or Master's degree (M.Pharma) in any specialization.
  
• Strong understanding of analytical techniques such as HPLC, GC, dissolution testing etc. .
  
• Experience with formulation development processes including solid orals & OSDs.