Job Description

The Manufacturing Downstream Associate is a hands-on position responsible for manufacturing operations that executes downstream processing tasks to purify recombinant proteins for a wide range of mammalian-based biosimilars. The employee will be responsible for purification of harvest material scale sizes 50L to 2000L within strict cGMP environments and execute strict quality documentation. This position also requires responsibilities such as preparation media/buffers, filtration, aseptic procedures biosafety cabinet and bioreactor operations, and cell removal filtration. 

Essential Duties & Responsibilities

Key responsibilities of the position include, but are not limited to – 

• Demonstrate a sound knowledge and understanding of cGMP requirements. Adhere to real-time documentation during production run and maintain accurate records/logs.
• Setup, operate, and break down downstream equipment including chromatography columns, controllers, and TFF systems.
• Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Perform calculations for processing, weighing materials, chemical and reagent additions. 
• Uses programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
• Works 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. Ensuring all operations comply with cGMP, safety, and data integrity standards.
• Performs other functions as required or assigned.
• Revision of solution preparation batch records, SOPs, Protocols and logbooks.
• Providing support during quality audits and regulatory inspections.

Material & Inventory Management

• 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.