• Involvement in planning and execution of all operations in a cGMP (Current Good Manufacturing Practice) environment including:o Media and buffer preparationo Knowledge in DeltaV programo Generation and proliferation of cell cultures in shake flasks and fixed (stainless) and disposable bioreactors, centrifugation, and depth filtrationo Clean in Place (CIP) and Steam in Place (SIP) of fixed tanks/vessels and portable equipment and Clean out of Place (COP) of miscellaneous parts and equipmento Proficiency and routine maintenance of analytical equipment including: pH/conductivity meters, bioanalyzers, osmometers, benchtop centrifuges, cell counters and microscopes• Coordinate daily activities and projects with support groups including: Automation, Engineering, Facilities, Process Development, Quality Assurance and Control, Calibration, Validation, and Supply Chain• Operation and practical knowledge of glass washers, autoclaves, filters, pumps and analytical equipment to support and monitor the process

- Subject-matter expert on TransCyte Growth processes.- Qualified trainer in cell growth processes.- Experienced and knowledgeable in proper cell growth techniques.- Responsible for the generation and review of batch records and standard operating procedures.- Supported management with document change control process.Key Achievements- Instrumental in relaunching an FDA-approved product by actively collaborating with Product Development, Manufacturing Technical Support, Validation and Quality groups in establishing process controls and product specifications.- Managed the interpretation of research process development studies for FDA submission.- Collaborated with Engineering/Facilities and Validation in equipment initial setup and qualification.

- Performed and handled proper aseptic techniques on a regular basis.- Managed the interpretation of research process development studies for FDA submission.- Knowledge in proper operation of the autoclave.- Assisted in the development and execution of equipment validations.