Role OverviewThe Manufacturing Associate II - Upstream is a hands-on position responsible for manufacturing operations that execute mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars.
What You Will Do
Execute cell culture batches from 50L to 2000L volumes within a current Good Manufacturing Practice (cGMP) environment, prepare media/buffers, filtration, aseptic procedures, biosafety cabinet and bioreactor operations, and cell removal filtration.
Requirements
- Demonstrate a sound knowledge and understanding of cGMP requirements
- Adhere to real-time documentation during production run and maintain accurate records/logs
- Set up, operate, and break down upstream equipment including bioreactors, depth filtration, and disposables
- Perform upstream processes at multiple scales in a cGMP environment
- Perform calculations for processing, weighing materials, chemical and reagent additions
- Use programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment
- Work with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment
- Follow all GMP instructions in the manufacturing area and take responsibility / ownership of environmental health and safety policies
- Coordinate the conduction of investigations and corrections for issues found during the batch execution process
- Comply with all company policies and standards
- Revision of solution preparation batch records, SOPs, Protocols and logbooks
- Providing support during quality audits and regulatory inspections
- Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes
- Perform label verification, receipt checks, and electronic inventory updates
- Coordinate with warehouse and planning teams for material readiness
- Managing material inventory inside cleanroom areas
]]>