Kamila Wlodarczyk Email and Phone Number

• Develop, scale-up and evaluate manufacturing process for lipid nanoparticle-based drug formulations and technology transfer from R&D to Process Development and to GMP production• Serve as key representative on multidisciplinary project teams to help define process and equipment requirements• Prepare and execute manufacturing batch records of processes at the R&D, Process Development and GMP production scale; support all aspects of the manufacturing of materials for GLP toxicology studies as well as manufacture of clinical trial material• Work closely with in-house Research, Analytical, GMP Manufacturing, Project Management, Quality Assurance, Quality Control, and Supply Chain groups during execution of clinical manufacturing campaigns• Prepare equipment and process flow diagrams; participate in equipment selection, procurement and design• Write, review, and perform equipment Design, Installation, Operation and Performance Qualifications to clear equipment for use in GMP Suite or R&D laboratory• Prepare SOP's, technical reports and data summaries. Effectively communicate in oral and/or written form to internal and external audiences

• Worked on process development for pilot-scale manufacture of conjugate vaccine• Carried out troubleshooting, maintenance and validation of laboratory equipment• Managed 4-month long formulation study to improve immunological response of vaccine• Prepared technical reports and SOPs

• Carried out experiments in templated polymer synthesis and microfabrication techniques• Performed data analysis, troubleshooting of findings, and presentation of results to supervisor and coworkers• Performed literature review of scientific papers