Single Use Facility, Manufacturing Manager Devens, MA

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Summary: The Shift Manager leads and drives the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMPs). The Shift Manager is responsible for management of a group whose primary focus is on execution of manufacturing processes technical assessment of processes maintaining a culture of compliance innovation and within their functional group. The Shift Manger is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities provide investigation support analyze process/equipment data and identify and implement process improvements.

Major Duties and Responsibilities:

Provides direct oversight of the execution of manufacturing unit operations. These operations include but are not limited to the use of the following equipment and or systems: i.e. bioreactors chromatography systems media/buffer preparation equipment etc.) process automation systems (i.e. Delta V and Syncade Interactions OSI/Pi Historian) and supporting business systems (i.e. SAP. Veeva Vault Maximo etc.).
Drives right first time (RFT) execution of manufacturing unit operations by providing direct training guidance and problem solving on the floor in real time.
Takes an active role in selecting and developing the team. This includes leveraging both internal and external relationships to build the best team possible.
Ensures team adherence to Good Manufacturing Practices and standard operating procedures.
Ensures daily work coordination and distribution as demanded through the manufacturing schedule.
Is responsible for maintaining schedule adherence and cycle time. Reports variances and communicates impact to cross functional groups.
Manage daily communication to shift personnel. Supports and drives shift huddles and functional team meetings. Provides shift handover and communication working with other shift team members.
Ensures oversight for critical operations through systematic walk down and checks of equipment and functional areas prior to execution. Review critical attributes and drive decisions.
Build partnership with Manufacturing Operational Engineer Support to ensure daily data review and trends accomplished seamless operations.
Provide critical communications upwards downward and across as deemed fit
Ensure shift notes communication is complete and accurate. Provide critical update summary to the staff for all safety incidents and significant process deviations.
Initiates response team for critical issues managing team progress and providing detailed communication to management.