Downstream Manufacturing Associate Iii
Current•Develop and write process and cleaning methods for AKTA skids in UNICORN. •Assist with method validation and facilitate transfer to MSAT and Engineering teams.•Closely work with MSAT and Engineering teams on troubleshooting and validation of methods not directly written on both ITT and AKTA systems.•Provide detailed feedback on method and process improvements.•Operate ITT and AKTA chromatography skids for process, packing, and validation.•PAL and Axichrom column packing and unpacking operations, pulse test.•Execute production documents following GDP and cGMP and editing.•Downstream processing for multiple products.•Participated in C1D2 manufacturing method development and execution.•Assist in technology transfer for CGMP manufacturing.•Work with a client and traveling to client on-site to better understand ad help facilitate the transfer of process.•TFF skid operation.•Depth filtration and Milipore POD filtration.•Analytical equipment operation using Solo VPE UV Vis for protein concentration determination and reporting of the results.•Prepare buffers and solutions used in commercial products.•Maintain FDA inspection readiness.•Provide manufacturing support of electronic inventory and tracking system rollout.•Provide support for manufacturing workstation rollout and setup.•Edit BPRs, SPRs, SOPs, and logs to comply with CAPAs and maintain compliance.•Equipment inspection, troubleshooting and maintenance.•Perform chromatography operations including skid and column sanitization, equilibration, and product collection.•Participate in certified trainer program and provide new hire training in downstream operations.
