Job Description

The Manufacturing Upstream Associate I is a hands-on position responsible for manufacturing operations that executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian-based biosimilars. Responsible for executing cell culture batches from 50L to 2000L volumes within a current Good Manufacturing Practice (cGMP) environment. 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.
• 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. 
• Uses 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. 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.