Manufacturing Associate Ii
Current• Assisted in the production of clinical and commercial products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) using SOPs and Batch Production Records• Executed operations in both upstream and downstream microbial manufacturing processes including shake flask fermentation, production fermentation, homogenization, resuspension, cell lysis, solubilization oxidation reactions, depth filtration, membrane filtration, column chromatography, ultrafiltration/diafiltration, formulation and bulk fill operations• Reviewed Batch Production Records and Solution Production Records for accuracy and completion as well proposed changes to documents to improve execution of procedures • Supported troubleshooting efforts for equipment and conducted functionality tests of repaired equipment• Obtained Aseptic Hood Qualifications for ISO 5 grade areas• Optimized the 5S program (lean manufacturing tool) to improve consistency and quality of facility operations• Mentored and trained new manufacturing employees on equipment and processing