Yevgeniya Plekhov

Senior Scientist @Societal Cdmo

Project management- Write business proposals per customer request. Update proposals and create change orders if requested. Communicate with customers. Negotiate service quotes with customers. Attend meetings, write agenda and meeting minutes. Update customer on project status, conduct risk evaluation and develop risk mitigation strategies. Confirm that customer requests are within scope of the contract- Research - Design research experiments that includes preformualtion studies: solubility, excipient compatibility, forced degradation. Write Research Protocols and research reports. Write in-use study protocols and reports. Design finished dosage form (tablet, capsule, powder in the sachet, oral liquid, liquid in the vials, lyophilized dosage forms). Design formulation according to customer requirements and complying with FDA guidelines. Design packaging configuration for finished dosage form to provide stability and accurate and consistent delivery of the formulation to the patient. Design matching placebo as per clinical trial requirements that includes color, taste and texture matching. Conduct short term stability studies. Analytical - Evaluate new analytical method before they transferred to QC that includes HPLC, spectrophotometry, titration and other methods. Design and execute dissolution method development protocols and write reports.