About this role
Summary: Provides manufacturing science and technology (MSAT) support for internal and/or external manufacturing operations across multiple modalities. Supports technology transfer, process validation, and ongoing manufacturing support activities to ensure processes are implemented, operated, and maintained in a compliant and reliable manner.
Essential Duties and Responsibilities:
· Support internal and external technology transfer activities, including participation in facility fit assessments and high-level gap assessments.
· Generate, review, and support documentation associated with technology transfer, including process descriptions, master plans, reports, and technical documents.
· Provide technical support to manufacturing operations during start-up, engineering runs, validation, and routine manufacturing.
· Leverage engineering principles during problem solving and process support.
· Review manufacturing documentation generated by receiving sites, including batch records, automation recipes, SOPs, and change documentation.
· Gather, trend, and analyze process data to support process understanding and ongoing process performance monitoring.
· Participate in investigations and deviation assessments and support identification of root causes and corrective actions.
· Apply engineering principles to the development and execution of manufacturing support activities.
· Analyze data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing support activities.
· Work effectively in cross-functional teams to support timely execution oSAT deliverables.
· Ensure activities are performed in accordance with cGMP.
· May lead others.
· Perform other duties as assigned.
· Travel to internal manufacturing sites or external partners as required (