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Date Created: 12/22/15
Shilla S. Niamehr Great Neck, NY 11024, 917.701.2188, email@example.com ____________________________________________________________________________ PROFESSIONAL HIGHLIGHTS Health science professional with extensive experience in pharmaceutical R&D, GLP, FDA regulations, and laboratory analysis. Demonstrated successful application of analytical and spectroscopic techniques (LC-MS/MS, HPLC, UPLC, PDA, UV-VIS, EC, Fluorescence) in separation and quantification of biological and non-biological samples (chiral/achiral). Strong laboratory experience in analytical and bioanalytical method development and validation of active pharmaceutical ingredients per regulatory agencies guidelines. Proficient in biological sample preparation and analysis (SPE, LLE and PPT). Proven ability in data and documentation review and approval. Expert technical writer. Wide knowledge in compliance with expertise in SOP writing and implementation. Excellent interpersonal, verbal, presentation and written communication skills with effective communication at all levels. Strong leadership skills. Vast knowledge of Instrumental softwares, instrument maintenance and troubleshooting: •Waters ZMD, HPLC and UPLC •Automation systems; Biomek and Tomtec. AB Sciex API Series •Waters MassLynx Watson LIMS •Waters Empower Nugenesis Data System •AB Sciex Analyst Microsoft Programs EXPERIENCE Scientist V, Bioanalytical Sciences, January 2010- January 2015 Forest Research Institute (subsidiary of Actavis), Farmingdale, NY Implemented complex multi analytes analytical and bioanalytical method validations to quantitate drugs and metabolites in various biological or non-biological matrices in support of toxicology, safety pharmacology, and clinical studies under regulatory agencies guidelines. Developed analytical and bioanalytical methods utilizingvariety of spectroscopic platforms (LC-MS/MS), automation workstations and bioanalytical extraction methods (e.g. SPE, LLE and PPT). Collected bioanalytical and drug metabolism data via experimentation to support product development. As a study leader supervised colleagues to perform sample analysis and quantification of drugs and metabolites in biological matrices in support of GLP clinical and no-clinical studies, review and acceptance of analytical data. Generated, audited and archived reports for method validations and bioanalytical studies. Performed maintenance and troubleshooting for Laboratories Instruments. Trained colleagues in various laboratory instruments and instrumental softwares. Established technically valid Standard Operating Procedures (SOPs) that presented current practices, reviewed and revised as appropriate to meet current FDA guidelines. Participated in Watson LIMS validation and training. Created in-house macros within Microsoft Excel program to automate routine calculations. Scientist II/III/IV, Bioanalytical Science, 2001- 2010 Forest Research Institute (subsidiary of Actavis), Farmingdale, NY 1 of 2 As a study leader supervised colleagues to perform sample analysis and quantification of drugs and metabolites in biological matrices in support of GLP studies. Participated in method validations and performed sample analysis to quantitate drugs and metabolites in various biological matrices. Maintained laboratories Instruments and resolved issues through effective troubleshooting. Provided formal and informal training for various laboratory instruments and instrumental softwares. PRIOR WORK EXPERIENCE Research Associate I Scientist - Pharmacokinetics/Drug Metabolism Purdue Frederick, Yonkers, NY 1992-1997 Participated in bioanalytical studies, assay validations and method development. As study coordinator, planed and organized routine operations for the entire Pharmacokinetics group. Provided HPLC data acquisition system support to the Pharmacokinetics group, trained new team members and participated in data acquisition system validation. Provided HPLC troubleshooting techniques to maximize sample throughput. Wrote and revised SOP's, equipment protocols, procedures and policies to meet current FDA guidelines. Participated in bioanalytical study report generation and archival. Summer Intern,6/1991-8/1991 Hoechst Celanese, Summit, NJ Participated in synthesis of third order nonlinear active copolymers to produce all optical waveguide devices, and development of the device design. Lab Assistant,6/1989-6/1990 Mount Sinai Hospital, NY, NY Measurement of enzyme activity in biological preparations utilizing Enzyme assay, Spectrophotometry, Fluorometry, and cell culture. EDUCATION Columbia University, School of Engineering, NY, NY B.S. Chemical Engineering, 1992 Yeshiva University, NY, NY B.A. Chemistry, 1992 Awards: The American Institute of Chemists Student Award,Yeshiva University Yablick Memorial Scholar, Columbia University PUBLICATION AbhijeetJakate, Partha Roy, Alpita Patel, Wattanaporn Abramowitz, Stefano Persiani, Julie Wangsa, Ram Kapil and Shilla Niamehr, “Effect of azole antifungals ketoconazole and fluconazole on the pharmacokinetics of dexloxiglumide”, Br J ClinPharmacol. Nov 2005;60(5):498-507. Brianne Weingarten, Hou-yehWang,Dale M. Roberts, Shilla Niamehr, “Determination of codein in human plasma by high-performance liquid chromatography with fluorescence detection”, Journal of Chromatography A, V696, Issue 1, April 1995, 83-92 K.Amsler,S.Ghatani (Niamehr), and B.A. Hemming (1991) cAMP-Dependent protein kinase epethelial cell properties. The American physiological Society.O363-6143:C1290- 99. PATENT Vertical Nonlinear Directional Coupler Using Polymer Thin Films. Robert A. Norwood James R. Sounik, Jacquelyn Popolo, Douglas Holcomb, Shilla S. Ghatani(Niamehr).Hoechst Celanese Patent No.30979C. 2 of 2
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