Organized the work of four analysts, gave guidance and instruction to successfully complete analysis for method transfer, verification and method validation.Wrote protocol and summary report for validation and method transfer.Assisted inn troubleshooting and resolving problems.

Successfully demonstrated the ability to independently conduct an ongoing project involving validation, method transfer, analytical analysis, including documentation and reporting of data for submission to FDA

Designs procedures independently using laboratory equpment and computer resources.Typically serve as a project leader/study director within group for complicated studies. Involved in planning my own work and supervising daily activities in the lab working under prescribed procedures (protocols/SOPs, STMs, etc...) Initiate and complete R&D, cGMP, cGLP studies and documents and reports data in accordance with regulatory guidelines. Plan and conduct studies. Monitor study procedures to ensure data accuracy and report quality. Conduct analyses, experiments, and investigations on substances for product and process development and application. Implement/perform qualitative/quantitative analyses and actively contribute to improvement of analytical methodologies. Responsibilities: quality and accuracy. •Conduct analyses and experimentation on substances, for such purposes as product and process development and application, quantitative and qualitative analysis, and improvement of analytical methodologies. •Design/perform complex experiments and procedures in accordance with all applicable regulatory (i.e., FDA, DEA, ICH, AOAC) requirements as defined by protocsol, standard test methods, and operating procedures. •Application of advanced mathematical concepts and operations to frequency distribution, determination of test reliability and validity. Analysis of variance, correlation techniques, sampling theory and factor analysis. •Evaluate/utilize equipment, and develop formulas, processes, and methods for solution of technical

• Provided method transfer and method deviation that involved analytical testing (Potency, RC, CU, BU and dissolution) for clean-out and finish product samples • Worked on method validation and performed analysis for specificity, linearity, repeatability, accuracy and reproducibility.• Analyzed raw material samples (appearance, ID test) and determined spectrum by using FTIR.• Provided swab samples from Pilot Plant instrumentations and performed clean out tests by using HPLC system. Determined conductivity.• Performed analytical testing (assays and dissolution) for comparison projects by using USP method.• Determined dissolution testing of extended-release products by Varian instrument.• Performed and documented analytical analysis for intermediates, in-process and stability samples from pilot plant by Water and 1200 Agilent HPLC using Empower system.• Organized and provided environmental monitoring for viable airborne and non-viable colonies.• Provided wet chemistry analysis (pH, conductivity, density, viscosity, hardness, moisture determination).• Organized QC Lab and had responsibility for calibration HPLC , UV spectroscopy and dissolution baths.• Reviewed analytical results , logged data in LIMS, represented diagrams and tables for presentation to validation, research and development group.• Handled and tracked all narcotic materials in compliance with Federal Policies.• Performed all procedures in accordance with GMP, GLP, SOPs and safety regulations as stipulated by FDA/CFR.

• Organized and provided laboratory work for analytical assays validation and impurities identification(prepared mobile phase, sample extractions and standards for analysis by using C18, C8, strong anion/cation exchange columns).• Conducted and documented instrumental analysis of flu medications, creams, controlled substances,and vitamins, utilizing HPLC, GC, Atomic Absorption, IC , and UV-VIS .• Determined extended-release products for dissolution testing by using Agilent system.