Gulzhan Menzeleeva Email & Phone Number

Rtp, Nc

United States

Designed, organized and delivered analytical testing, method validation, and method transfer activities for successful launch of multiple drug products (solid and inhaled dosage forms).• Led multiple Design of Experiment (DoE) studies in fast-changing environment.• Implemented new ways of working for high throughput testing using multiple automation equipment in parallel for Cascade Impaction testing and all available recourses effectively. • Recognized with Exceptional Science Award for delivery of necessary modification and validation of method for inhaled product in aggressive timeline for launching new product campaign.• Designed and executed experiments for comparison of performance of new equipment as part of method evaluation.• Performed method transfer activities to Contract Research and Global Manufacturing Supply laboratories for analytical methods (inhaled and solids products): authored transfer protocols and reports, performed testing, analyzed and compiled data. Recognized by multiple awards for completion method transfer activities in aggressive time lines.• Delivered comprehensive training to team members on test methods for inhaled products: Impurities, Cascade Impaction, Total Drug Content, Microscopic evaluation, Delivered Dose as well as Basic laboratory skills training for new starters. • Experienced in setting up laboratory in new site and closing laboratory activities (instruments change control, decommissioning etc.).• Participated in AMQbD (Analytical Method Quality by Design) activities. Contributed to regulatory submissions by compiling product stability data. • Authored and executed validation test cases for ELN (Electronic Laboratory Notebook) templates in LabWare.• Received multiple Bronze awards for completion of method transfer activities in aggressive timelines.

Rtp

Performed analytical high throughput testing of the inhalation products (MDIs) for stability studies and investigational work to support pharmaceutical regulatory submissions. Performed GMP CI testing for different (root cause investigations, stability) projects. Performed stability testing: Impurities, Content, DTU, TDC, Microscopic evaluation for inhaled products (MDIs). Performed method development, validation and performance qualification for ASRS (Andersen Sample Recovery System).• Participated in projects: ODT / LDT formulation development, SoluBeads, Gastric Retention Formulations, Oral Relenza and Oral Insulin.• Received awards for: Contribution to delivery of automated testing for Cascade Impaction testing; Delivery in challenging timeline supporting validation activities for impurities method in order to address FDA request as a part of sNDA submission; and Delivery of high quality results as a part of regulatory submissions.