Prashant Gaikwad

• Professional with 12 years of experience in formulation development of solid oral dosage forms.
• Proven track record of developing Generic Formulations including Scale-up and Technology Transfer experience to Pilot/Exhibit Scale.
• Skilled in analyzing and interpreting research results and technical data
• Proficient in interaction with cross functional teams
• Experience in working in high pressure environments with strict deadlines.

• To understand project scope, define the activities and timelines and to ensure periodic monitoring and timely completion of the same.
• Lead on the execution/development of new formulations by investigating characteristics of API and its viability, safety and preformulation studies, defining the material characteristics, performing required testing, and conducting scale up studies.
• Identify the resource requirement for the projects such as materials, machine change parts as well as to assimilate all the literatur
• Responsiblee information collected by project teams and ensure appropriate usage throughout development.
• Responsible for pre-formulation, product development and establishing product stability as per the target market requirement and matching MMD profile with targeted reference product.
• Responsible for suitable pack selection and stability data interpretation.
• Coordinate with CFTs to ensure the targeted timelines of each project are met.
• Ensure smooth transfer of products from R&D to plant scale and perform gap analysis (technical) and provide technical support for site transfers/new launch products.
• Provide technical support for process improvement and troubleshooting on commercial batches as per requirement. Handle OOS/OOT/Deviation during batch execution / new launch products.
• Responsible for AVD / cost reduction batch execution as per the regulatory norms.
• Provide technical presentation at each stage of product development involving cross functional teams wherever required.

• Date of Birth: 01/07/1988
• Marital Status: Married

English, Marathi, Hindi

I consider myself familiar with pharmaceutical aspects. I hereby solemnly affirm that all the information furnished by me is true to best of my knowledge.