What are the responsibilities and job description for the Manufacturing Associate I (Night Shift) position at KBI Biopharma?
The Manufacturing Associate night shift will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and / or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH / conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance. The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities : learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability.
The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to various unit operations including media / buffer preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as to analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH / Conductivity / osmolality meters). Following task execution, the Manufacturing Associate I / II will review the executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance.
