Senior Bioprocess Associate - Devens MA

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Position Summary 

The Senior Bioprocess Associate uses current Good Manufacturing Practices (cGMPs) in the execution of commercial manufacturing processes for the manufacture of therapeutic proteins used in medicines that are revolutionizing the treatment of serious disease. 


Key Responsibilities 

Works on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions, where the ability to recognize deviation from accepted practice is required.  
Adheres to Good Manufacturing Practices and standard operating procedures. 
Revise and create process documents and assist with process related investigations 
Train for proficiency in process automation and supporting business systems and in the operation of primary production equipment within the assigned functional area. 
Operates primary production equipment within the assigned functional area (i.e. bioreactors, chromatography skids, media or buffer preparation equipment, etc.) as instructed. 
Lead in maintaining material and components inventory level 
Support a safe work environment and contribute to area specific initiatives associated with work safety 
Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes.  
Completes work instructions and maintains a clean room environment to comply with regulatory requirements. 
Effectively uses in process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo, etc.) to maintain production records. 
Work on routine manufacturing assignments per written procedures that are moderately complex with minimal instructions 
Assist in revising and creating process documents (i.e., SOPs and Batch Records) and assist with process-related investigations. 
Assists with reviewing batch and exception reports associated with each manufacturing lot, in conjunction with supervisor and Quality representative. 
Aid with area specific initiatives associated with work safety