Lymari Rodriguez Rosado Email & Phone Number

Accomplished Research Scientist with extensive experience in analytical testing and development for a wide variety of drug substances and drug products in leading pharmaceutical and biopharma companies. Expertise in interpretation of test results, method development, validation, technical transfer and Quality Control activities. Skilled at preparing protocols and technical reports in support of laboratory investigations and global regulatory submissions. Excellent communication, leadership and team building skills. Proficient in using Waters Empower software for acquisition, processing and reporting of chromatography data. Comprehensive background in production and inventory management. Fluent in English and Spanish.Expertise:* Development and validation of analytical methods* Testing of clinical supplies and stability samples* Review and approval of GMP test results* Writing of SOPs, methods, protocols and reports* Statistical analysis for data interpretation* Working knowledge of FDA, EMA and ICH guidelines* Formulation and technology transfer support* Laboratory investigations and change controls* Training of scientists under cGMPs* Qualification and calibration of GMP equipment* Coordination of product development activities* Experience with USP tests and other compendiaAnalytical Technologies:HPLC, UPLC, LC Prep, UV-Vis, PDA, LC-MS, GC-FID, GC-MS, FT-IR, dissolution, KF, disintegrationSoftware:Waters Empower, Agilent ChemStation, TotalChrom, PDLIMS, STARLIMS, SQL*LIMS, LabWare LIMS, Symyx ELN, Velquest ELN, eQRMS, TrackWise, DryLab, NuGenesis SDMS, ChemDraw, MS Office (Word, Excel, Access, PowerPoint and Outlook)

Listed skills include Hplc, Gmp, Validation, Analytical Chemistry, and 46 others.

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  University Of Puerto Rico-Rio Piedras

  Bachelor’S Degree