Nerijus Makauskas

Design the studies based on the defined deliverables in the Scope of Work. Plan the activities to meet the project deliverables and timelines by working closely with project managers. Have a solid understanding of regulatory issues and the impacts on purification process. Serve as a technical expertise at the client meeting. Independently develop recombinant protein purification processes by procedures. Including, but not limited to: chromatography process, ultrafiltration / diafiltration, nanofiltration, process characterization and optimization, process scale up, scale down model qualification, viral clearance validation. Knowledgeable to perform trouble shooting and root cause analysis and risk assessment, provide the support to the production through product life time. Transfer developed downstream processes to manufacturing group, including documentation and technical know-how through training and side-by-side operations at the pilot runs. Be trained in general cGLP and GMP procedures and those specific to protein purification process. Execute and record experiments in laboratory notebook accurately and timely. Write/revise process development reports and technology transfer protocols as needed. Attend project-team meetings. Present and discuss the data and project progress at those meetings. Ensure and maintain safe laboratory environment and work practices. Help to maintain laboratory and order common supplies. Train others on lab protocols.

Cells disruption (Microfluidics, APV, bead mill, sonication), proteins purification in variable scale (Akta purifier, explorer), microfiltration, process optimization (DOE), bioanalytical techniques (PAGE, enzyme assays, spectroscopy).

Ensured establishment of GMO in all stages of their delivery to market and controled GMO disseminated for commercial and any other purposes, PCR research, DNA Sequencing