RESPONSIBILITIES

• Literature survey for the scientific understanding of the drug product and finding the qualitative and quantitative composition of the drug product.
• To support on the Raw material sourcing required for the drug product development.
• To perform the pre-formulation studies and other formulation studies involved during the development of the drug product.
• Preparation of protocols and reports for the various studies during the drug product development.
• Knowledge in the Quality by design (QbD), design of experiments and ICH regulatory guidances.
• Timely execute the compatibility studies, lab scale stability and other various studies for formulation development of injectable drug product.
• Interpretation of different analytical data (Chromatography, Physical tests etc.) and thereby planning the next experiments.
• Preparation and following of Product development reports (PDR), Standard Operating Procedures (SOP`s) in the premises.
• Preparation of Pilot batch manufacturing documents like Batch manufacturing record (BMR), Submission batch protocols, stability protocols etc.
• Support in the execution of Pilot batches in the manufacturing site.
• Demonstrate a sense of urgency and a “Can-do” attitude.

REQUIREMENTS

• Bachelor’s degree or higher in Pharmacy.
• 2 years of experience in a similar FR&D role within Pharmaceutical manufacturing.
• Excellent verbal and written communication skills in English is a must requirement.