Sudhakar Naik

Dedicated and motivated Officer with 3.0 years of experience in formulation development of Technology transfer & site transfer of oral solids, capsules dosage forms (OSD), Emulsions and suspensions. Complete knowledge on product development & process understanding, meticulous documentation and filing to ensure accuracy and regulatory compliance.

Officer– Technology transfer department at Shilpa Medicare LTD (2025-06 – Present)

• Preparation of trail feasibility batch protocols for the execution of feasibility batch and preparation of report.
• Responsible for RM, PM, SFG and FG code creation for new products.
• Analyze difference between equipment design and capacities and coordination with plant and other technical members in order smooth products transfer between R&D to plant.
• Review and finalization of draft BOM, MFC, MPC packing stability protocols sampling protocols in coordination with R&D production QA and documentation team.
• Involve in trouble shooting during transfer monitor execution of transfer revision of documents and process validation in order to enable smooth products transfer between R&D and plant.
• Support for manufacturing packing and engineering teams and trouble shooting for technical matters related to new projects new products introduction of smooth transfer of products from R&D to plant.
• Responsible for all QMS activities related to technology transfer products. CMO projects execution and supporting.

Research associate – Technology transfer department at RISING PHARMACEUTICALS LIMITED, Shamshabad (2023-08 – 2025-05)

• Review & extraction & segregation of updated documents from dossier.
• Review of product manufacturing Gap assessment, Raw material gap assessment & packing material gap assessment.
• Review of engineering batch/ scale up batch BMR & sampling plan. Execution of Scale up batch, Exhibit batches at respective CMO's. Review of batch reports, stability protocols & reports.
• Review of performing compatibility studies with respect to regulatory compliance.
• Coordinating with cross function teams, collection and sharing technical documents with FR&D, AR&D, Production, Quality assurance, Quality control and Regulatory affair departments.
• Preparation and review of batch records like BMR, BPR, stability protocols, stability reports, IC BMR. Scale up batches execution & batch records review

Master of Pharmacy in Pharmaceutics – Santhiram College of Pharmacy, JNTUA (2021 – 2023)