Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion,
Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work
seamlessly across all areas and will be an SME for multiple areas.
Leads new products introductions (NPIs) into CCTC with support from biological
development (BD) and tech transfer teams (MSAT). Ensures all activities are tracked and
performed to schedule.
Actively collaborates with BD and MSAT to ensure cross functional alignment with platform
process, equipment, raw materials and/or automation.
Manufactures products in various phases of product life cycles from clinical thru launch.
Clearly understands, communicates, and manages complexity in terms of documentation,
sample handling, automation and cGMPs etc. for different phases of product life cycle.
Manages, handles and troubleshoots single use technology (SUT) from end to end in
manufacturing process.
Monitors and controls all aspects of manufacturing processes using data trending and /or
statistical process control. Works cross functionally to ensure process is controlled and issues
are escalated and investigated.

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