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[QUOTE=rajeev soni;193321]RAJEEV B. SONI [b][/b]: rajeevsoni.bhu AT gmail.com PROFESSIONAL SNAPSHOT A Pharmacist with 7 years & 6 months of experience in formulation development for global markets, presently designated as Senior Research Scientist in Product Development Research department with Ranbaxy Research Laboratories, Gurgaon, a renowned research based Pharmaceutical Company. Educational Status - Qualified GATE 2003, scoring 99.01 Percentile with all India Ranking 61. Examinations Institution/ University Year Main Subjects studied % of Marks Obtained M.Pharm Institute of Technology, Banaras Hindu University 2005 Pharmaceutics, Biostatistics, Biopharmaceutics and Clinical Pharmacokinetics, Novel Drug Delivery System, Dissertation Work 81.2% B.Pharm Rajiv Gandhi University of Health Sciences, Karnataka 2002 Pharmaceutics, Pharm. Chemistry, Pharm. Analysis, Pharmacognosy, Pharmacology, Pharm. Microbiology, Forensic & Community Pharmacy, Biochemistry, Dispensing, Hospital and Clinical Pharmacy 60.6% Diploma in Total Quality Management & ISO 9000 Indian Institute of Management & Technology (IIMAT), Chennai 2002 Total Quality Management 74% Diploma in Business Organization and Management IIMAT, Chennai 2003 Business Management 71.5% - Currently pursuing Ph.D (Pharmacy) under the supervision of Prof. Dr. G.Vidyasagar. Thesis will be submitted latest by April 2012. International Research Publication - In Vitro and in Vivo Evaluation of Buccal Bioadhesive Films Containing Salbutamol Sulphate, Chemical and Pharmaceutical Bulletin, 58 (3) 307-311, March 2010. Core Competencies - Good understanding of quality based ICH guidelines, module 2 and module 3. - Effective coordination with team by educating stringent means for routine product development activities. - Coordination with Marketing for getting New Product Development Request in a specified format. - Preparation of technical write-up required for form 12, form 44 for new formulations. - To give technical support to regulatory affairs department in solving country specific product related queries. [b]- Coordination with Purchase and Production Planning Inventory Control (PPIC) regarding procurement of raw materials (Active along with Technical Package and Vendor COA, Inactives along with vendor COA), packing materials along with COA and miscellaneous materials (Tools [/b]: punch sets, packaging change parts as per physically evaluated market samples or other In-House product development strategies). Getting raw material and packing material code generated by PPIC department under timely authorization by QA. - Getting raw materials and packing materials tested by In-House Analytical Testing facility. Getting In-House COA generated accordingly. - Coordination with QA-Validation and Engineering departments for obtaining IQ/OQ/PQ reports of every machine and instruments in the premises of F&D department. Monitoring calibration of every instruments on timely basis. - Good understanding of literature survey along with Patents relevant for desired formulation development. - Good understanding of preformulation studies, formulation development trials, dissolution medium selection criteria, analytical (Assay, Dissolution, Related Substances) method validation work, comparative product characterization, ICH compliant stability studies in proposed/ alternative market pack and understanding of Bioequivalence (Pilot/Pivotal) studies. - Coordination with Packaging Development department and getting generated related Master Documents (Master Packing Card, Foil Artwork, Insert Artwork, Label Artwork, Carton Artwork). - Good understanding of Technology Transfer Documents (Test License, Pharmaceutics Development Report, Master Formula Card, Master Packing documents, Raw Material Specifications, Finished Product Specifications (Release and Regulatory), Standard Analytical Test Procedures, Stability Reports). - Good understanding of trouble shooting, as and when required, by analyzing process parameters of different manufacturing and packaging stages. Career Highlights Ranbaxy Research Laboratories, Gurgaon January 11 –Till Date - Responsible as Senior Research Scientist (PDR) to lead the team of Research Scientists & Research Associates. - Responsible for pharmaceutical development projects (New source API evaluation for solid orals) from development to technology transfer for leading markets (USA/ Brazil/ EU/ EM). - Trouble shooting by conducting lab trials (stage I, stage II, stage III) with application of DOE and data interpretation. - Pursuing gap analysis & Formulation support to Regulatory Affairs department from driving grids (EU, USA, Brazil/ Mexico grids) for line extension of products to emerging markets (Rest of African & Rest of Latam countries). Ensuring country based requirement of Pharmacopoeial compliance of products. - Ensuring smooth launching of products in outsourced manufacturing locations. - Country based Query response for filed dossiers. - Execution of confidential technology transfer documents (API specs, IP/PR/FP specs and corresponding STP’s) through Documentum Compliance Manager (DCM) software. J.B. Chemicals and Pharmaceuticals Ltd, Ankaleshwar January 08 --January 11 - Was responsible as Manager (F&D) for Pharmaceutical Development projects; Project Tracking and coordination (Technical) for New Product Development; Responsible for technology transfer of Products; Project management of contract research project; Coordination with packaging development, procurement, Analytical, Costing, Marketing, Patent Cell, medical services, Production for both New Products and Site Transfer; Budgeting and Budgetary control. - Planning and execution of Exhibit Batches/ Validation Batches for India and Advanced Markets. - Execution of Process Validation Protocols/Reports, Test Batch Monitoring Protocols/ Reports, Review of Stability Protocols/ Reports. - Review of Analytical Method Validation Protocols and Reports - Trouble shooting for USA market and other advanced markets. - Demonstrated proficiency in generation and compilation of data required for quality overall summary and module 3, intended for EU. Also involved in effective coordination with Medical Services department regarding compilation of data concerning Non-clinical study reports and clinical study reports. Alkem Laboratories Ltd., Mumbai September 05-- January 08 - Formulation and Development of Solid Dosage Forms for USA Markets from Preformulation Studies to Final Pivotal Bio Batch execution. - Was responsible to develop, scale-up, and validate commercializable robust products for USA Market. Trouble shooting for process and products. Support stability group. Review and analyze stability data. - Worked in Novel Drug Delivery Systems such as In-Situ Gel based Oral sprays, Nasal Sprays, Sustained release tablets, Enteric coated tablets for Advanced Markets - Process development ; characterization, ranging and optimization; Facilitate Transfer of Technology (New products) ; Provide validation support for product site transfer ; Process audit, Identify process / product anomalies and address process deviations, regulatory guidance to internal partners. - Preparation of CTD (Module 2 & Module 3) for USA market. Lupin Limited, Mandideep February 02-- January 03 - Trainee Officer (Process Development-Formulation). - Dossier review, arrangement and adequate availability of all relevant documents (Master Formula Card, In-Process, Product Release and Regulatory Specifications, Raw Material (API and Excipients) Specifications, Stability Protocols). - Execution and Subsequent technology transfer of Oral and Sterile (Dry Powder for Injection) Cephalosporins Products pertaining to Advanced and Domestic Markets in USFDA, UKMHRA approved formulation manufacturing unit. - Ascertaining feasibility of trials and tooling development. Trouble shooting and route cause analysis. - Preparation of Manufacturing and Packing Batch Production Records (Intended/ Commercial/ Hospital Supply) pertaining to Domestic and Export Markets of Oral and Sterile Cephalosporin Products. - Preparation of Test Batch Monitoring, Process Validation Protocols, Stability Study Protocols, Hold Time Study Protocols and Compilation of Test Batch Monitoring, Process Validation, Stability Study, Hold Time Study Reports of Oral and Sterile Cephalosporin Products and other Reports of Experimental Batches conducted by Process Development Lab from time to time. [b]Reason for leaving [/b]: Joined M.Pharm course of prestigious IT, BHU on UGC Fellowship Instrument/Machine Skills - Experience in understanding instruments and machines like Silverson Homogeniser, Emulsiflex 160 Homogeniser, Sterile manufacturing tank, filtration tank, sterilization & depyrogenation tunnel, Compression machine, Rapid mixer granulator, Fitz Patrik® Roll compacter, Fluidised bed drier, Multimill, Supermill, , Planetary Mixer, Vibrosifter, Auto Coater with PLC, Brookefield Viscometer, Ultrasonicator, UV Spectrophotometer, IR moisture analyser. Computer Skills [b]- Operating Systems [/b]: MS- DOS, MS-WINDOWS - Working Knowledge of SAP, Documentum Compliance Manager Notice Period - One month or subject to relieving by present employer whichever is earlier.[/QUOTE]
