Primary responsibilities include. Perform routine cleaning and disinfection operations for the production support and process equipment according to Standard Operating Procedures. Perform manufacturing and disinfection activities in areas including but not limited to Cell Culture, Purification, and Solution & Equipment Prep. Assist with writing and editing SOP’s and maintenance of production equipment. Maintain records and clean room environment to comply with regulatory requirements, GMP, and SOPs.Froulate and recommend improvements to manufacring policies and programs. Assist in training personnel.

Routine manufacturing operations on production equipment according to SOPs and procedures.Manufacturing activities of full scope, to work functions in Buffer Prep and Purification. Set up and operations of CIP and Buffer Transfers Training of staff members in Buffer Prep.Utilized Trackwise, SAP, LIMS system database. Reviewed Manufacturing Batch Records, Equipment Use Logs and Maintained records in a clean room environment to comply with regulatory requirements, cGMP, and SOPs

Routine manufacturing operations on production equipment according to SOPs and procedures.Recovery of unclarified cells thru Recovery filtration skids, UFDF systems, Chromatography skids and Columns.Manufacturing activities of full scope, to work functions in Cell Culture, Purification, Solution and Equipment Perp. Perform set up and operations of, Incubators, Wave bags, Bioreactors and Centrifuges.Experience in performing in Trackwise and LIMS system database. Review of Manufacturing Batch Records, Equipment Use Logs and Maintains records in a clean room environment to comply with regulatory requirements, cGMP, and SOPs. Responsible for the training of staff members.

Trained staff on Media and Equipment Prep operations, acting as a resource during internal and external inspections, troubleshooting issues within the facility, and leading and/or contributing on various projects.• Serve as departmental lead for corporate wide transition to disposable systems project• Serve as departmental lead for the compliance triage team and delegate any applicable action items to team members• Partner with facility engineer and perform quarterly facility inspections• Function as Operational Excellence lead for shift and act as a resource for any on-going projects• Contribute to Site safety goals through performing daily awareness sessions with team and presenting safety metrics at monthly staff meeting Manufacturing Operator• Worked on CIP validation and automation commissioning team during start-up• Lead P&ID system walk downs in the facility• Participated in Media Prep engineering lots• Participated in various Kaizen events

Primarily responsible for recognizingSafety and production goals, including; employee relations,Scheduling and evaluations, along with many of the duties of LineTechnician.• Coordinated a team to effectively start and run a new production line• Ran new line at substantially better up rates, recovery times and safety record• Created an atmosphere of teamwork and respectLine Technician Responsible for production, blending raw materials, setting and monitoring conditions in the Dye, Winder and Pelletizer areas, troubleshooting and problem solving, quality control and line testing.• Trained new employees, prepared, and supported them until working independently.• Started at entry level 1• Received above average annual reviews, resulting in promotion to