MODA-ES and MODA eLogs Proficient in SAPLaboratory Information Management System (LIMS) softwareAssist in the production of high-quality viral vectors, adhering to cGMP standards and internal SOPs.Perform transfection and amplification of viral vectors using various cell lines, ensuring optimal yields.Conduct quality control assessments, including PCR and sequencing, to validate vector integrity and functionality.Collaborate with cross-functional teams to troubleshoot production issues and implement process improvements.Maintain accurate and detailed laboratory records, ensuring compliance with regulatory requirements.Train junior technicians

Conducted the production and purification of viral vectors (e.g., AAV, lentivirus) for gene therapy applications.Performed cell culture techniques, including transfection and infection of mammalian cells, to optimize vector yield.Executed quality control assays, including PCR, ELISA, and flow cytometry, to ensure vector integrity and functionality.Collaborated with cross-functional teams to troubleshoot production issues and streamline workflows.Maintained detailed documentation in compliance with GMP regulations.

UNICORN software experience.Medium to Large-scale Chromatographic systems (ÄKTA).Tangential Flow Filtration experience utilizing cassettes.Nanofiltration and depth filtration.Direct experience in cell manufacturing/commercial biologic drug manufacturing operations in a GMPenvironment.

GMP manufacturing Buffer and Media PrepSupport daily manufacturing operations, ensuring compliance with cGMP guidelines and internal procedures.Operate and maintain manufacturing equipment, performing routine calibrations and preventive maintenance.Monitor production processes, collecting and analyzing data to ensure optimal performance and quality standards.Assist in the documentation of manufacturing activities, ensuring accuracy and compliance with regulatory requirements.Collaborate with cross-functional teams to identify and resolve production issues, implementing corrective actions as needed.