Manager, MSAT Direct Hire MA

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Job ID: 16009 Direct Hire MA

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Our client is a public, mid-sized therapeutics company in the northern suburbs of Boston & Cambridge with approved product already on market and a strong pipeline.  They are seeking an experienced Engineer with leadership abilities and cGMP experience with a focus on Process Controls, Statistics, Modeling, and Data Analytics to join their growing MSAT group.  This is your chance to lead the Process Controls function and have a major impact on getting therapeutics to market for rare disease!  

The main function of this role is to ensure that the manufacturing control strategy is implemented and compliant at internal manufacturing and/or external manufacturing partners.  You will also have the opportunity to expand upon and help build a culture of continuous improvement - Six Sigma and/or LEAN experience welcome!

Responsibilities include but are not limited to;
•  Building in-house capabilities and implementing process optimization.
•  Data analysis of our existing and developing operations.
•  Support implementation and validation of a centralized data collection system and manufacturing database.
•  Support and/or lead statistical modelling efforts via tools such as JMP and Minitab.
•  Work with appropriate continuous improvement tools such as OE and process controls integration.  Implementation visual management/MDI, project management excellence, VSA & Kaizen’s. 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS in Engineering or relevant discipline and 8+ years of experience or MS/MBA with 5+ years of experience.  Must have 5+ years of process modeling, controls strategy implementation and proven experience with statistical modeling techniques.  Previous hands on experience in automation and/or data collection systems such PI and iHistorian is desired, but not required.  Knowledge of SQL and database design desired.

Must be authorized to work in the US indefinitely to be considered and must be commutable to the northern suburbs of Boston & Cambridge or able to relocate with limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.