Stephen Archer Email & Phone Number

Baltimore, Md, Us

Rockville, Md, Us

Brentford, Middlesex, Gb

Somerset, Nj, Us

Gaithersburg, Maryland, Us

- Support entire pilot plant purification, cell culture, fermentation, and support operations -Focus on Cell Culture- Rockwell Software Recipe Editor -Wrote and Maintained fixed tanks and bioreactor recipes- Perform inventory spare parts program in SAP for Cell Culture- Manage preventive maintenance plans in SAP for Cell Culture - Worked with quality groups to perform investigations into issues using Maximo and SAP work order system- Commissioned Millipore POD depth filters for Harvest Operations- Core team member on Million dollar project to Install and Commission Centrifuge for Harvest Operations- Team member on Million dollar project to Install and Commission High Temperature Short Time for viral inactivation of media- Team member on project to Install and Commission Refine Alternating Tangential Flow for Perfusion Harvesting- Worked in quality systems Trackwise with quality groups to improve process and equipment operations (SIPs, Pressure Holds, CIPs) using Non-Conformances and Validated System Change Requests- Process Information (OSI PI) Super User creating PI tags, saved PI process graphics, Trending for investigations and production records- Process Alerts Administrator for creating and maintaining email alarms on the PI system- Troubleshot communication issues Rockwell Software Devicenet issues - Wrote and equipment owner for Cell Culture SOPs- Troubleshoot automation issues with Rockwell Logix 500/5000 Systems: Recipe Editor, Equipment Editor, RSMACC, and RSView Studio- Trainer in Bioreactor operation, Fixed Tank operation, and special projects- Worked with development groups on Phase 1 and 2 production runs

Gaithersburg, Maryland, Us

- Write and Revise SOPs, MPRs, and SPRs for cGMP pilot lab..- Trainer in Inoculum and Sterile Operations, Bioreactor equipment, Fixed Tanks, and Transfers- Maintain cell culture growth from vial thaw to 2000L scale bioreactors in a multi-product pilot plant producing clinical material.- Work with Commissioning to install and start-up new Bioreactors, Portable and Fixed Tanks, Pall microfiltration and purification skids, automated CIP system, Analytical Suite and Process Control System.- Work with Validation to Validate the process on Bioreactors, Portable and Fixed Tanks, Pall skids, Analytical Suite, and Process Control System.- Team lead of developing CIP cycles and recipes for Fixed and Portable tanks, Bioreactors, and Lines.- Team lead on Microfiltration skid: Evaluated new filter cartridge selection for production with small scale testing with development group, Created MPR and SOP from scratch, Created all MF recipes, Performed process development to large scale, and worked with engineers to correct communication issue between Rockwell Logix clients and Batch and HMI servers. - Troubleshoot equipment issues with Rockwell Logix 5000 Systems: Recipe Editor, Equipment Editor, RSMACC, and RSView Studio

Gaithersburg, Maryland, Us

- Write and Revise SOPs, MPRs, and SPRs for cGMP pilot lab..- Trainer in Inoculum and Sterile Operations, Bioreactor equipment, and Fixed Tanks - Maintain cell culture growth from vial thaw to 500L scale bioreactors in a multi-product pilot plant producing clinical material.