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Beroe Inc India Chennai : Pharma Research Analyst
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[QUOTE=jknmn;99255]Jitendra Kumar Nigam [b]e-mail [/b]: jknmn AT yahoo.com [b]OBJECTIVE [/b]: ___________________________________________________________________________________________ To work for an esteemed organization where I can explore my knowledge and technical competence for development of an organization, as an active member of a dynamic team. [b]- PROFESSIONAL,EXPERIENCE [/b]: _____________________________________________________________________________________ [b]Current [/b]: Senior Research Scientist, Analytical Development Laboratory, Jubilant Organosys Limited, Noida, India. (Since October 2005 to till date) [b]Previous [/b]:Senior Reseach Chemist Analytical Development Laboratory, Ranbaxy Laboratories Limited, Gurgaon, India. (Since April 2003 to September2005) Senior Executive Analytical, Morepen Laboratories Limited, Solan H.P., India. (Since October1998 to Feb-2003) Executive (R&D API synthesis), Morepen Laboratories Limited, Solan H.P., India. (Since June 1994 to Octber 1998) [b]TECHNICAL EXPERTISE [/b]: ____________________________________________________________________________________________ - Leading the team of scientists - Analytical method development and stability study of drug products - Preparation and Standardization of working standards. - Preparation of protocols for stability studies and preparation of - Complete analysis of generic drug products targeted for US EU SA and UK market. - Active support to formulation department for the complete stability studies of drug products to established the shelf life and their specifications. - API evaluation according to pharmacopoeia as well as vendor’s method. - Trouble shooting in routine analysis. - Manage, maintain and Calibration of analytical instruments. - Preparation of method transfer sheets and standard test procedures. - Ensuring regulatory compliance by maintaining of appropriate requisite documentation/records. - Technology transfer of various analytical methods for API/Formulations and excipient analysis from R & D area to plant area. - Mentoring and training postgraduate trainees and new recruits on chromatography and related techniques. - Analysis of raw materials, packing materials and other packaging componants. - Review and write the SOPs [b]INSTRUMENTAL EXPERTISE [/b]: ____________________________________________________________________________________________ [b]ANALYTICAL INSTRUMENTS [/b]: HPLC - Waters alliance (2695 separation module),having empower software. - Shimadzu prominence. - Agilent(1100 series) Preparatory HPLC (Waters, Agilent)for impurity seperation. UPLC - WATERS Acquity. UV-Visible Spectrophotometer – - Shimadzu 1601 with UV probe - Perkin Elmer Dissolution Apparatus [b]- USP-I & II [/b]: Distek (2100C), electrolab(TDT-08L) Autotitrator (Orion & Metrohm) and other laboratory instruments Other instruments like, rotavapour, crystallzers frability, viscosity, hardness, bursting strength appratus etc. [b]ACADEMIC CREDENTIALS [/b]: ____________________________________________________________________________________________ - Master of Chemistry majoring in Organic & Pharmaceutical Chemistry, DBS College Kanpur, Kanpur University, 1990. - Bachelor of Science from DBS College Kanpur, Kanpur University, 1988 [b]ACHIEVEMENTS & AWARDS [/b]: _____________________________________________________________________________________________ Recipient of 6 month Research fellowship (polymers research) Project at DBS college Kanpur affilated to Harcourt Butler Tech Institute Kanpur. [b]INDUSTRIAL TRAINING [/b]: _____________________________________________________________________________________________ Six months Industrial training at Morepen Laboratories Limted Ltd., Masoolkhana, Solan during M.Sc. [b]PROJECTS ACCOMPLISHED [/b]: ____________________________________________________________________________________________ - Synthesis of 6 Amino pencillonic acid carried out by enzymes reaction at bulk production scale. - Synthesis of various antibiotic molecules like Ampicillin Amoxycillin cloxacillin Sodium. - Synthesis of various hot zone molecules like Cisapride Salbactum sodium Loratadine and Omeprazole. Synthesis study carried out on a series of chemical reactions _________________________________________________________________________ METHOD DEVELOPMENT - Analytical Method Development for various APIs and drug products for different unions like US, EU, Brazil, Soth Africa and other ROW - Various wet chemistry method development for domestic and regulatory markets. METHOD VALIDATION - Preparation of analytical method validation protocol - Validation of Assay Method of Formulations and APIs - Validation Dissolution Method of solid dosage form - Validation of Related substances of formulation products and APIs DOCUMENTATION, TRAINING AND QUALIFICATION OF INSTRUMENTS - Review of Documents and Test Date Sheets - Preparation, implementation of Standard Operating Procedures (SOPs) - Preparation of General testing Procedures (GTPs) - Training of Personnel - Calibration and Validation of HPLC, UV, Dissolution apparatus. - Preparation of volumetric solutions and standardization - Calibration of Analytical Balance, stability humidity chambers photo stability chambers and other analytical labs instruments and equipments. Seminars and Training - Attended 10days training programme on total quality management - Attended Five days secession of guideline of risk management (ICH Q-9) - Training attended on LIMS and Neugensis software for comprehensive analytical labs solutions - Management skills effective communications - Delivered seminars on analytical method development and stability studies. Other informations Well acquanted with hazardious reactions like Hydrgenation, Methoxyllation chlorination bromination. Also performed reactions like, alkyl halide, Grignard reaction Reimer Tiemann reaction.etc. Approved chemical analyst from Drug controller Shimla H.P. [b]DECLARATION [/b]: _____________________________________________________________________________________ I hereby declare that the information furnished above is true and to the best of my knowledge. [b]Place [/b]: Noida [b]Date [/b]: 30/04/11 Jitendra Kumar Nigam[/QUOTE]
