1/510 Road street, Siruvallur village and post, Contact No: +91-8838801656 KalasappakkamT.K, Thiruvannamali DT,606906 OBJECTIVE: o To work on an innovative and challenging job to expose my talent and ability to undertake job responsibilities and strive for the success of the organization in which I am working. EDUCATION: o I’m doing Master of Pharmacy in TN Dr. MGR Medical University (Pursuing). o I was Completed my Bachelor of Pharmacy in TN Dr. MGR Medical University (2016 – 2020) o Carry out literature search on APIs, Formulation, Patent search, Selection of Excipients, Roles & Responsibilities: Technologies for the development of Solid oral dosage forms (Tablet: IR, DR and ER dosage forms, Capsules: Powder and Pellets filled), Parenteral dosage forms and developing robust formula and manufacturing process. o Prepare product development strategy and discuss day-to-day time-line updation of allocated projects with group leader and R&D Head. o Carry out pre-formulation studies like, formulation and excipient screening and compatibility studies, selection of Excipients and feasibility trials for process selection. o Prepare application for trade dress approval. o Assessment of projects requirements like RM/PM, tolling, change part, RLD samples etc. o Preparation and review of laboratory note book. o Plan, ensure and exhibit calibration for instruments and balance. o General laboratory monitoring and maintenance activity. o To ensure cGMP practice and regulatory requirement. o Preparation of various documentation like: Master Formula Card (MFR), Finished Product Specification, RM/PM Specification, Indent request, Stability protocol etc. Risk assessment, SOPs, etc. o Handle equipment like RMG, FBP/FBD, Multimills/co mills, Blenders, Compression Machine, Conventional coater/Auto coater, Capsule filling machine, Sonication, pH meter during product development. o Carry out optimization of formulation development which includes various key activities like; Trials and error, Solubility, Dissolution optimization, OPD study, Stability study, Process optimization and finalization and scale up batches. o Responsible for submission of trials and stability batches for analytical analysis (e.g. Dissolution, Assay, Related substance, content uniformity water content etc.). o Responsible for stability protocol preparation, review, compilation and interpenetration of stability results. o Carry out technology transfer of scale up batches to demonstrate feasibility and robustness of the formulation and selected manufacturing process. o Perform the execution of exhibit/process validation batches. o Preparation of final product development report (PDR) which broadly includes; Drug Substance details, Pre-formulation studies, Product development details, Innovator characterization, Stability studies, Packing details, Microbial attributes and Packaging/Container closure details. o Partner with manufacturing, QA, QC, SCM team and extend specialization to resolve any product related issues. o Extend cross functional support to RA and share Product Development Report for Dossier Submission. o Conducting the trouble shooting of formulations/product in terms of composition (formulation) and process (method of manufacturing). EXPERIENCE: o Executive in Manufacturing Science and Technology Department in Strides Pharma Science Limited, Karnataka from Jun.2023 to still now. o Executive in FR&D Department in Bal Pharma Limited, Karnataka from Aug.2022 to June 2023 for 11 months. o Executive in FR&D Department in Ultra Laboratories Pvt. Ltd Hassan, Karnataka from Feb.2021 to Aug.2022 for One and half Years. SKILLS & TECHNOLOGY: o Formulation development, Process development, Process Optimization, Stability Studies, ICH guidelines, FDA/EMEA/WHO guidelines, Technology Transfer, Patent Search, Immediate/Delayed/Extended Release Dosage form, Capsules, Sterile dosage forms, Scale up, Bioequivalence, Literature survey, ANDA, USFDA. EMEA, WHO, CDSCO/DCGI, Regulatory market. o Self-Confident o Sincere and dedicated in work o Punctuality and Hard work. o Ability to quickly adapt to new environments and learn new technologies. PERSONAL DETAILS: o Name: GOKUL V o Father’s Name: Mr. Vediyappan K o Date of Birth: 26.08.1999 o Marital Status: Single o Gender: Male o Religion: Hindu o Nationality: Indian o Blood Group: B+ o Language Known: Tamil, English (Read, Write and Speak), Kannada(Speak) DECLARATION: I hereby declare the information furnished above is true to the best of my knowledge and belief.