Research Scientist- MS&T (OSD)

Role & responsibilities

• Review and provide technical inputs on Product Development Reports (PDR), Master Formula Cards (MFC), and Technology Transfer (TT) documents.
  
• Prepare product process-related risk assessments, protocols, and reports for feasibility trials and scale-up batches.
  
• Execute trial and scale-up batches, and prepare summary reports.
  
• Prepare and review Exhibit Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
  
• Support regulatory filing by providing intended commercial BMR, BPR, and stability evaluation summaries.
  
• Support regulatory in obtaining Test Licenses, Import Licenses, No Objection Certificates (NOC), and Manufacturing Licenses by providing the necessary product and process-related documents.
  
• Review and provide Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) as part of the Annual Product Review.
  
• Initiate New Product Introduction (NPI) procedures for new product manufacturing at the site.
  
• Responsible for implementation of Process Analytical Technology (PAT) at the manufacturing facility for process improvement.
  
• Exposure and experience in working on Injectable/Parenteral and Oncology projects.
  
• Review and provide technical inputs on PDR, MFC, and TT documents.
  
• Prepare product process-related risk assessments.
  
• Prepare and review Exhibit BMR and BPR.
  
• Initiate NPI procedures for new product manufacturing at the site.
  
• Support regulatory filing by providing intended commercial BMR, BPR, and stability execution summaries.
  
• Prepare Standard Operating Procedures (SOPs).
  
• Prepare position papers, justification reports, and technical reports.

• Position based at Formulation site- 40 Kms. away from Vadodara city.

Preferred candidate profile

B.Pharm or M.Pharm