US-MA, Manufacturing Sciences, Senior Engineer II SR0039884-MZ
As a key member of Manufacturing Sciences team, this individual will be responsible for providing technical and scientific leadership to support the cell culture processes of commercial manufacturing operations. Responsibilities will include monitoring of the process, containment of process failures and deviations that occur during cell culture processes, and coordination and implementation of associated corrective and preventative actions. The individual will also participate and function as the Manufacturing Sciences lead on technology transfer and process improvement teams. This individual will also provide expertise and leadership to the upstream Manufacturing Sciences group.
Job Function and Description
35% Floor Support Support ongoing operations on the manufacturing floor.
15% Continuous Improvement Work with manufacturing staff to identify opportunities to improve the consistency and robustness of process operations.
15% Provide technical expertise and leadership to the upstream Manufacturing Sciences group.
15% Process Monitoring A key part of this role will be assisting with continued development of the process monitoring capabilities for manufacturing cell culture operations.
10% Tech Transfer Support the transfer of phase I, II/III clinical processes into the existing GMP manufacturing facilities as define by Tech Transfer group
10% Quality System Support Lead consistent and well documented response to process operations events to support investigations, deviation closure as well assistance to change control/CAPA as appropriate.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
The candidate will:
Other Job Requirements
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