Hari Devulapally Email & Phone Number

1) Bioanalytical Function Lead with 16+ years experience in Bioanalysis of small and large molecule in a fully regulated GLP environment.2) Leading team of Scientists for Pk and Method development and Method validation and study sample analysis.3) Experienced in facing FDA, ANVISA, UK MHRA and other global regulatory inspections, fully understanding of Compliance requirements.4) Prepared analytical procedures, protocols, SOPs, STP, Reports, audit report closure, database, automatic calculation sheets, spread sheets using MS Excels and WATSON LIMS system. 5) Possess Strong Analytical skills with good Knowledge of extraction techniques and ability to extract compounds from Test Matrix using Liquid Liquid extraction techniques (LLE), Solid phase extraction (SPE), protein precipitation extraction (PPE) and Double extraction techniques for Derivatiazing procedures. 6) Performed Data acquisition on Waters (Xevo TQS ) coupled with ACQUITY UPLC waters, Sciex LCMSMS API 4500, API 5000 and Thermo LSMSMS platforms using Analyst software and Micomass instruments using Masslynx software and LC quan for thermo instruments.7) Review of Quality and interpreted bioanalytical data generated accordingly to study protocol and applicable regulatory requirements.8) Documented results by using Watsons LIMS and prepared study reports for study director and sponser's review and assessment.9) Initiated interaction with multiple function groups within company to establish a positive collaboration working environment.

Listed skills include Pharmaceutical Industry, Cro, Hplc, Lc Ms, and 2 others.