Purpose Statement

• Performs functions associated with cGMP manufacturing operations within the biologics production facility.
• Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
• Serves as a highly skilled subject matter expert within the manufacturing area, contributing to the development of concepts, techniques, and process improvements.
• Supports and drives troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan. 

Major Responsibilities:

• Executes manufacturing operations to perform operations including but not limited to equipment cleaning and set up as well as stream specific operations like:  

  • Upstream: Vial Thaw, Inoculation, Cell Culture and Recovery 

  • Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling  

  • Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, Sampling of raw materials.  

• Execute on computerized systems (such as Delta V, SAP and MES) for process control and data entry
• Adhere to safety requirements in all tasks, report incidents and near misses promptly, and assist with Safety, Health, and Environmental (SHE) incident investigations.
• Participates in resolution of anomalous processing events
• Assists lead in planning production schedule and leading area activities
• Performs advance process and equipment troubleshooting
• Coach and train junior biotechnologists in area of expertise
• Sets a positive team environment and inculcates a nurturing AbbVie culture