Frankfurt, Hesse, Germany
Experienced Senior Project Manager with a demonstrated history of working in the biotechnology, clinical trials and supply chain industries. Skilled in biomanufacturing, supply chain, GMP and GCP processes. Strong program and project management professional with proven leadership skills.
Successful implementation of Phase I and BA/BE unit for clinical trials for international CRO - Comac Medical Ltd. in Belgrade, Serbia; Consultancy for sites selection to be included in Phase II/III clinical trial of novel vaccine. All sites successfully passed audits and are selected as primary or back up sites for a trial; Clinical site coordinator on site of Special gynecological hospital "Jevremova" in Belgrade, Serbia. Phase II/III clinical trial of Influenza vaccine, named “A phase 3 double blinded, randomized, placebo- controlled study to examine the safety and immunogenicity of a seasonal trivalent split inactivated influenza vaccine produced by Institute Torlak in 18–65 year old volunteers in Serbia”
Application for funds for influenza vaccine production; Budget justification and management; Equipment procurement for Influenza vaccine manufacturing facility; Preparation of plans for facility refurbishment; Quality assurance - cGMP introduction and maintaining in production process; Preparation of procurement, refurbishment and production plans, preparation of reports; Leading of production team (QA, QC, QP, clinical manager, medical officer and production personnel) through establishment, development and validation of production processes; Guide company through preclinical trial (documents preparation, approval and report on trial); Preparation of sponsor´s documents for clinical trial - Phase I (Investigator´s brochure, Study protocol, IMPD, etc.).
Project documents preparation for WHO project - Influenza vaccine production and control; Production process development, introduction and optimization; Supervising technicians in productions; Control tests development; SOP (Standard Operating Procedures) writing and introduction; Quality assurance in accordance with cGMP and ISO standards.
Taking care of production of vaccines, sera, devices and dietary supplements; Preparing of production plans and plans for improvement and development; Quality assurance; Meetings and collaboration with relevant national and international companies and agencies; Lead of Board for intellectual improvement at company.