On a typical day I perform formulation development (Critical Quality Attributes) and Process optimization (Critical Process Parameters) for Oral Solid and liquid dosage form using QbD as per the R&D director instructions. I Conduct physical/lab tests in making qualitative and quantitative analysis for formulation. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Perform developmental trial to improve existing product and processes. Prepare and review BMR/MMR; Product Development Report (PDR), Process Characterization/ Validation Protocols and Reports, Quality overall summary (QOS) and other necessary documents to support ANDA filing.
Supervise and provide guidance and direction to R&D technicians.
Consult and interact with Process Engineers, Manufacturing, Analytical R&D, Quality Control, Validation, and QA departments to coordinate pilot, submission (ANDA), registration, and Validation batch manufacturing.
Emcure has highly educated and experienced Scientists in R&D.
Hardest part of the job is to always move/run constantly from Manufacturing floor and R&D lab, since both the facility were completely separate from each other.
Most enjoyable part was working in a team as a family & friends.