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[QUOTE=Guest-IJT;112806][b]Name [/b]: Arpita Chatterjee [b]Email [/b]: arpitaiit AT gmail.com [b]Designation / Skillset[/b] : Worked in Formulation R&D,Regulatory affairs ,Pharmacology in academics,Cell culture Dear Sir/Mam, I have nearly 4 yrs experience in leading MNC Pharmaceutical company,Worked in Formulation R&D ,Regulatory adffairs cell celture.I have pursued B.Pharm with distinction and M.Tech from IIT Chennai.I wish to work in the areas of Formulation R&D,Cell culture,Project management,RA,ip Etc. [u][b]Resume[/b][/u] : Seeking a challenging career with a Pharmaceutical Industry of high repute.. Location -Bangalore Professional Synopsis [b]- Total 3years 10 months experience in Pharmaceutical Company in the following areas [/b]: In Dr Reddy's Laboratories Ltd -Cell Culture (Upstream Fermentation Process) and in Formulation Development and in The Himalaya Drug Co in Regulatory Affairs. - Proficient in Strategic Planning & streamlining systems with proven ability to enhance Development and operational effectiveness and meet goals within the time & optimized parameters. - Possess problem-solving, research skills and interpersonal communication skills. [b]Employment Chronicle [/b]: [b]Aug'2007- June' 2010 [/b]: Dr Reddy's Laboratories Ltd, Hyderabad [b]Sept' 2010-till date [/b]: The Himalaya Drug Company, Bangalore [b]CAREER INTEREST [/b]: R&D [b]ACADEMIA [/b]: - M. Tech in Medical Biotechnology from Indian Institute of Technology,Dept of Biotechnology, Chennai in 2007 with 7.4/10 CGPA. - B. Pharm from Bharati Vidyapeeth's Poona College of Pharmacy, Pune in 2005 with 72% (Ist class with Distinction) - XII, ICSE from Mount Assisi School, Bhagalpur in 1997 with 60%. - X, ICSE from Mount Carmel School, Bhagalpur in 1995 with 80%. [b]- Currently pursuing PGDBA through correspondence [/b]:Specialisation: Operations Management from Symbiosis, Pune. [b]ACADEMIC PROJECT [/b]: (In IIT M.Tech) [b]Topic [/b]: Targeting Acid Sensitive Ion Channel (ASIC) for controlling acid mediated ischemic injury and anginal pain. [b]Area [/b]: Pharmaceutical Biotechnology, Medicinal Chemistry [b]Synopsis [/b]: - Selection of drug for alleviation of anginal pain& injury after stroke. - Explore whether the channel mediates in sensation of Angina & ischemia in CVS & CNS respectively. Worked on Cell lines to explore role of Acid sensing ion channel (present in vitro in N2A cell line ) in isachemic injury and angina pain.The ASIC gene was expressed in Hela cell line,CHO cell line by transfection and cytotoxicity based assay method were tried out by exposing to low pH 2.Performed LDH assay. 3.Cell deaths were evaluated by a drug named Amiloride. [b]KEY RESULT AREAS IN INDUSTRY [/b]: [b]Biologics Division,Dr Reddy’s Lab ,Hyderabad in Upstream Fermentor Lab [/b]: [b]CELL CULTURE [/b]: 1.Revivals of cells 2.Subculturing 3.Optimizing for culture growth and Viability. 4.Spinner vs Fermentor Experiments 5.Clone selection. 6.Media & Feed Preparation. 7.Metabolite Profiling. [b]Formulation Development& Scale up in IPDO,Dr Reddys, Hyderabad (for Regulated Markets) [/b]: [b]1. Technical Review of the Product [/b]: Product Development Report, Process Evaluation Data, Exhibit batch data ,study of impurities ,specifications etc &presenting the observations. 2. Execution of R&D Batch & Scale Up batch for robust , reproducible & scalable product.. 3. Responding to deficiency Queries from Formulation aspect to various regulatory agencies. 4. Formula Optimization and Process modification with Strategies. 5. Physicochemical Characterization of Reference listed drug. 6. Preformulation studies -API characterization. 7. Ensure the compatibility of API and excipients. 8. Optimizing formulation in cases of changes for eg API Particle size change. 9. Analyzing root causes of failures of batches & finding solutions for smooth validation of the product. 10.Monitoring stability studies. 11.Update on regulatory guidelines and worked withen the scope of stringent regulatory famework. 12.Co-ordination with RA, QA, QC, Analytical R&D ,IP etc. [b]Main projects in Solid Oral Formulations in Dr Reddy's Laboratories Ltd, Hyderabad [/b]: - Drug to treat Allergic Rhinititis - Drug to treat CNS Disorder. - NOTABLE HIGHLIGHTS - Scored 1st as Technical trainee in Ist technical review & got confirmation as Junior manager. - Received HK Firodia memorial award (Rs 5000 cash prize )for excellence in science and technology for Essay writing.(Focussed on Food Processing) - Successfully optimized parameters to obtain the acceptable values of Assay &UOD in a modified drug layering process. [b]International Regulatory Affairs, Himalaya Drug Co,Bangalore [/b]: - Dossier Compilation for Asian Market. - Review of documents as Formula & its revision, Process, Specifications & Specification revision, Active ingredient, Change control, Packaging, stability ,Impurities ,Clinical & Preclinical studies etc - Documentation and Life cycle management of all products’ documents Updating Regulatory guidelines such as ICH,CTD ,FDA etc Training - Training given by Dr. Reddy's to cover all areas of Pharma Industry & Research for 10 days. - Training by Fred Rowley on Unit Operation in Formulation for 3 days. [b]REFERENCES [/b]: 1. Mr I Srinivas Director,Formulation R&D Dr Reddy’s Laboratories Ltd,Hyderabad [b]Mail id [/b]:isrinivas AT sify.com 2.Dr K R Mahadik Principal & Professor. Poona College of Pharmacy and Research Centre Pune-38 ------------------------------------------------------- [b]More Information about this submission and submitter [/b]:- ___________________________________________________ Submission ID : 4210910 Date & Time : 4th Jun 2011 1:35 PM (UTC) IP Address : 117.192.126.34 Browser Info : Mozilla/5.0 (Windows NT 5.1; rv:2.0.1) Gecko/20100101 Firefox/4.0.1 Predicted Country : India[/QUOTE]