Manager, Formulation development
Rising Pharmaceuticals
Total years of experience :14 years, 2 Months
● Responsible for delivering of new product development/site transfer activity with assigned timeline.
● New product Ideation
● Product development trouble shooting
● Monitor the lab activities and adhere to strict deadlines and standards for safety and quality product.
● Lead a team of scientists in product development work
● Write Review departmental SOP, protocol, technical report, finding the business opportunities and developing strategies
● Support Regulatory Department in Post development activity by preparing appropriate response to queries from regulatory bodies.
● Study analytical and bioequivalence data to draw conclusions
● Reformulation and cost reduction strategies for branded formulations
● Complex generic product development strategies
● Responsible for Identify and fix issues related to process inefficiencies.
● Experimental design and Formulation optimization
● Patent search and Infringement analysis
● Prepare of PDP, PDR, MFR, MPR, stability protocols and other documentation
● To coordinate with cross functional team to way forward the project
● Completed projects within budget and timeframe.
● Selection of drug candidates for ANDA and NDDS
● Complex generic product development strategies
● Experimental design and Formulation optimization
● Prototype development for characterization of novel dosage forms
● Pre-formulation development of NCEs
• Designed the project concepts and communicated to Funding agencies for grants
• Worked on various research projects
• Monitored PG and UG students for their research activity
• Taught Pharmaceutics and Biopharmaceutics, for UG and PG students
• Pre-formulation study
• Experimental design and Formulation optimization
• Formulation development and characterization of novel dosage forms
• Reformulation and cost reduction strategies for branded formulations