Senior Scientist I - Cell Culture

We are seeking a highly motivated Senior Scientist I to join our Manufacturing Science and Technology (MSAT) group in the Product Development Science and Technology (PDS&T) organization supporting biologics manufacturing at the AbbVie Bioresearch Center based in Worcester, MA.  As part of the PDS&T Biologics organization, our group leads the process technology transfer, continuous improvement, validation, and continuous process verification activities for late-stage and commercial manufacturing of therapeutic proteins for AbbVie. We also provide technical support for manufacturing, GMP compliance, and regulatory filing.  The candidate should have extensive experience and comprehensive knowledge in process development, characterization, and validation of cell culture strategies to solve complex challenges across the AbbVie pipeline. The candidate will be expected to mentor and potentially supervise junior level scientists and productively manage several projects simultaneously in a dynamic and rapidly evolving project landscape.   

Responsibilities:

• Lead team on the design, execution, and data-analysis for process development, characterization, optimization, validation, and continuous process verification activities for large-scale GMP cell culture processes.  
• Identify, evaluate, and develop innovative technologies within the field of cell culture to improve product quality and process efficiency and robustness for biologics manufacturing processes 
• Lead team on technology and process transfer activities to GMP scale across AbbVie’s GMP manufacturing network. 
• Solve technical issues and support GMP manufacturing of therapeutic proteins, including organization of deviation investigations. 
• Participate in cross-functional teams to support CMC sections of regulatory filings 
• Author technical reports and validation documents  
• Interact with cross-functional groups (e.g. , process development, protein analytics, manufacturing, quality, and regulatory) 
• Author peer-reviewed articles and patents and present original work in conferences 
• Expertise in data analysis or programming techniques is preferred with experience in analyzing large complex data sets, including model development.  
• Highly autonomous and productive in performing laboratory research, requiring only minimal direction from or interaction with supervisor.